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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
| Musculoskeletal Injury Rehabilitation Research for Operational Readiness | FED |
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Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study.
SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain.
SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study.
METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function.
LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.
Recruitment, Pre-Screening (before consent), Study Introduction & Informed Consent:
Potential participants will be identified via four methods:
Eligibility will be determined in person. If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF and expresses interest in participating, an authorized study team member will initiate the formal consent discussion and, if applicable, obtain informed consent.
Baseline Data Collection (post-consent): Prior to receiving the assigned study treatment, participants will provide their contact information and complete a series of baseline outcome measures (Demographics CRF and Baseline Data Collection CRF) and have their plantar fascia thickness measured within the Podiatry clinic. A study team member will also acquire measurements of the participant's calf, ankle, and foot to calculate the appropriate PBMT dose.
Randomization: Participants will be randomly assigned to a study group (PBMT+UC or Sham PBMT+UC) using a computer-generated randomization model prepared by the study biostatistician.
Study Treatments (PBMT+UC or Sham PBMT+UC): All participants, regardless of study arm assignment, will be asked to complete the UC Protocol, which consists of a daily regimen of stretching and cryotherapy that includes 3-5 minutes of stretching upon waking, then approximately 3-5 minutes of stretching and 3-5 minutes of cryotherapy throughout the day, for the duration of 6 weeks.
Participants will receive PBMT or sham-PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on the treatment area (size).
Photobiomodulation Therapy (PBMT): PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. The Smart Hand Piece is calibrated to shutoff when moving too slowly, and warn the operator when moving too fast by vibrating. The therapy is delivered through a flexible optical fiber threaded through the hand piece, which contains a rolling sapphire massage ball. The PBM therapy will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin.
Sham-Photobiomodulation Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. The following safeguards will be in place to prevent exposure to PBM and potential unexpected crossover or protocol deviations, as follows:
The PBM device requires multiple steps to emit photons. The device first must be powered on, then settings are selected (in this case, power will be 25 watts, and the time will be determined by the algorithm based on the treatment area measurements). Next, there is a 'standby' button that is activated on the touch screen, and finally, there is a finger switch on the handpiece that must be pressed to initiate the treatment. There is a beep that sounds for the duration of the active treatment.
For the sham condition, the device will be turned on and the settings will be selected, but the standby button and the finger switch on the handpiece will not be activated. This way, there is no chance that the device will be emitting photons. Since the device will not emit active treatment, there will not be a beeping sound from the device; this beeping noise will be replicated in another way for the sham-PBMT. At the completion of the initial 6 weeks, Sham-PBMT participants will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If Sham-PBMT participants choose to cross-over and receive active PBMT, participants will re-complete all of the original study procedures (with the exception of screening).
Follow Up Data Collection: In addition to their 3x weekly for 3 weeks PBM or Sham-PBM treatments, participants will report to the study team in person approximately 3 weeks (+/- 3 days) and 6 weeks (+/- 3 days) after the start of their PBM or Sham-PBM treatment to complete the follow-up questionnaires, turn in their Pain Diary, and undergo ultrasound imaging to measure changes in plantar fascia thickness at 3-weeks and 6-weeks.
Long-term follow up questionnaires will be captured remotely (e.g., entered directly into REDCap using a personalized coded link with no log-in required, verbally over the phone with a study team member, etc.) at approximately 3-months (+/- 10 days/weeks) post-start of PBM treatment. For Sham-PBMT participants who cross-over, their 3-month follow-up will be timed from the first day of their active PBM treatment, not their Sham-PBM treatment. Reminder phone calls and emails will be sent to participants at the phone and email address provided to the study team before the 3-month follow-up time point. Participants will be evaluated for adverse events at each follow-up time point and any complications will be documented.
Study participation ends after the 3-month follow-up research activities are completed. Participants initially randomized to the PBMT group will participate in the study for approximately 3 months. Participants initially assigned to the Sham-PBMT group who choose to cross-over and receive active PBMT post-unblinding will be in the study for approximately 4.5 months total.
Ultrasound Measurement: Plantar fascia thickness will be measured by an MSK US trained provider utilizing an ultrasound system. The participant will be identified on the ultrasound system using only the assigned participant ID. The patient will be positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia will be evaluated in the long axis to determine the site to be measured as identified by the bony contour demonstrated. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured will be from the edge of the bone to the outer layer of the plantar fascia.
Plantar fascia thickness will be measured in two orthogonal planes (90 degrees different - long axis and short axis of the structure) at the site identified by the bone contour. The measurement will be conducted by MSK US trained providers, either in Physical Therapy or Physical Medicine and Rehab clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Usual Care + PBM Group | Active Comparator | Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. |
|
| The Usual Care + Sham (Placebo) PBM Group | Placebo Comparator | Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment. At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation Therapy (PBMT) | Device | Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | Baseline |
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 3-Week |
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 6-week |
| Foot and Ankle Ability Measure (FAAM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19952249 | Background | Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257. | |
| 15377971 | Background | Dyck DD Jr, Boyajian-O'Neill LA. Plantar fasciitis. Clin J Sport Med. 2004 Sep;14(5):305-9. doi: 10.1097/00042752-200409000-00010. No abstract available. |
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Any research data shared with an approved agency for review will be linked only to the participant's unique study ID and not with the personal identity of the participant. If the research data is used in scholarly presentations or journal articles, the investigators will protect the anonymity of individual participants and report only aggregate data where appropriate. Participants will not be individually identified in any publication or presentation of research results.
De-identified research data will be shared with Military Injury Rehabilitation Research for Operational Readiness (MIRROR) and maintained indefinitely for possible use in future research.
De-identified data will only be accessible by authorized study team members and oversight officials, the local Madigan Human Research Protections Office, the IRB, authorized staff from USU, and authorized staff from Musculoskeletal Injury Rehabilitation Research for Operational Readiness, which is based out of the department of Physical Medicine & Rehabilitation at USU, and is serving as the data coordinator.
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71 participants consented, 2 were withdrawn prior to randomization (1 self-withdrawal, 1 withdrawn by PI). 69 were randomized to the study treatments.
71 consented to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Usual Care + PBM Group | Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. Photobiomodulation Therapy (PBMT): Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. |
| FG001 | The Usual Care + Sham (Placebo) PBM Group | Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment. Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 participants withdrew from the study prior to randomization and 69 randomized participants were analyzed for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | The Usual Care + PBM Group | Participants that were assigned to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received receive 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size). PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | Posted | Mean | Standard Deviation | Percentage of function | Baseline |
|
All participants were evaluated for adverse events during their participation at each follow-up visits(3 weeks, 6 weeks, 3 months, 3-week cross-over, 6-week cross-over, 3-month cross-over) using a standard questionnaire on the IRB-approved follow-up case report form. From August 11, 2022, to October 31, 2024, 7 serious adverse events and three adverse events were documented during the study period. The events were not related to the research procedure.
All adverse events, regardless of severity were reported to the Principle Investigator. The study overall is considered to be minimal risk for study participants, defined as not substantially above what would be encountered in everyday life including provision of routine medical care for the condition of plantar fasciitis. All adverse events, regardless of severity were reported to the Principal Investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Usual Care + PBM Group | Participants that were assigned to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size). PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm Injury | Injury, poisoning and procedural complications | Systematic Assessment | At the 6-week follow-up, the participant informed the study team that they injured their arm at work and were hospitalized prior to the follow-up. The participant continues to follow up with the patient care management for the injury. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | At 3-week follow-up, the participant reported minor increase in foot pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Metzger, Scientific Program Manager | The Geneva Foundation | 253-383-1398 | emetzger@genevausa.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2023 | Feb 22, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2024 | Feb 22, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Participants will be randomly assigned to one of two treatment groups: usual care with PBM therapy, or usual care with sham PBM therapy.
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Single blind masking. The study team knew which group participants were randomized to. Participants did not know which group they were in until after 6 week follow up visit.
|
| Sham-Photobiomodualtion Therapy (Sham-PBMT) | Device | Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons. |
|
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.
| 3-month |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | Baseline |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 3-Week |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 6-Week |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 3-Month |
| Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | Baseline |
| Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | 3-Week |
| Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | 6-Week |
| 3-Week Cross-over |
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 6-Week Cross-over |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 3-Week Cross-over |
| Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 6-Week Cross-Over |
| Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 3-month Cross-over |
| Pain Diary and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 3-month Cross-over |
| 24559879 | Background | Rosenbaum AJ, DiPreta JA, Misener D. Plantar heel pain. Med Clin North Am. 2014 Mar;98(2):339-52. doi: 10.1016/j.mcna.2013.10.009. Epub 2013 Dec 10. |
| 12851352 | Background | DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013. |
| 24626080 | Background | Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113. |
| 25214839 | Background | Franceschi F, Papalia R, Paciotti M, Franceschetti E, Di Martino A, Maffulli N, Denaro V. Obesity as a risk factor for tendinopathy: a systematic review. Int J Endocrinol. 2014;2014:670262. doi: 10.1155/2014/670262. Epub 2014 Aug 19. |
| 21882780 | Background | Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006. |
| 23156094 | Background | Roy TC, Knapik JJ, Ritland BM, Murphy N, Sharp MA. Risk factors for musculoskeletal injuries for soldiers deployed to Afghanistan. Aviat Space Environ Med. 2012 Nov;83(11):1060-6. doi: 10.3357/asem.3341.2012. |
| 25280610 | Background | Cameron KL, Owens BD. The burden and management of sports-related musculoskeletal injuries and conditions within the US military. Clin Sports Med. 2014 Oct;33(4):573-89. doi: 10.1016/j.csm.2014.06.004. |
| 12756315 | Background | Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234. |
| 23054045 | Background | Orchard J. Plantar fasciitis. BMJ. 2012 Oct 10;345:e6603. doi: 10.1136/bmj.e6603. No abstract available. |
| 25239050 | Background | Franceschi F, Papalia R, Franceschetti E, Paciotti M, Maffulli N, Denaro V. Platelet-rich plasma injections for chronic plantar fasciopathy: a systematic review. Br Med Bull. 2014 Dec;112(1):83-95. doi: 10.1093/bmb/ldu025. Epub 2014 Sep 19. |
| 19083680 | Background | Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3. |
| 8913160 | Background | Tountas AA, Fornasier VL. Operative treatment of subcalcaneal pain. Clin Orthop Relat Res. 1996 Nov;(332):170-8. doi: 10.1097/00003086-199611000-00023. |
| 25709971 | Background | Miller LE, Latt DL. Chronic Plantar Fasciitis is Mediated by Local Hemodynamics: Implications for Emerging Therapies. N Am J Med Sci. 2015 Jan;7(1):1-5. doi: 10.4103/1947-2714.150080. |
| 20117600 | Background | Jones BH, Canham-Chervak M, Canada S, Mitchener TA, Moore S. Medical surveillance of injuries in the u.s. Military descriptive epidemiology and recommendations for improvement. Am J Prev Med. 2010 Jan;38(1 Suppl):S42-60. doi: 10.1016/j.amepre.2009.10.014. |
| 25936814 | Background | Canyilmaz E, Canyilmaz F, Aynaci O, Colak F, Serdar L, Uslu GH, Aynaci O, Yoney A. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):659-66. doi: 10.1016/j.ijrobp.2015.02.009. Epub 2015 Apr 28. |
| 19440137 | Background | Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009 Jun;17(2):100-4. doi: 10.1097/JSA.0b013e3181a3d60e. |
| 25844681 | Background | Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available. |
| 22045511 | Background | Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2. |
| 23912778 | Background | Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3. |
| 19913903 | Background | Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13. |
| 22541305 | Background | Tumilty S, McDonough S, Hurley DA, Baxter GD. Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):733-9. doi: 10.1016/j.apmr.2011.08.049. |
| 18248158 | Background | Tumilty S, Munn J, Abbott JH, McDonough S, Hurley DA, Baxter GD. Laser therapy in the treatment of achilles tendinopathy: a pilot study. Photomed Laser Surg. 2008 Feb;26(1):25-30. doi: 10.1089/pho.2007.2126. |
| 19708800 | Background | Tumilty S, Munn J, McDonough S, Hurley DA, Basford JR, Baxter GD. Low level laser treatment of tendinopathy: a systematic review with meta-analysis. Photomed Laser Surg. 2010 Feb;28(1):3-16. doi: 10.1089/pho.2008.2470. |
| 25450903 | Background | Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2. |
| 19347936 | Background | Oliveira FS, Pinfildi CE, Parizoto NA, Liebano RE, Bossini PS, Garcia EB, Ferreira LM. Effect of low level laser therapy (830 nm) with different therapy regimes on the process of tissue repair in partial lesion calcaneous tendon. Lasers Surg Med. 2009 Apr;41(4):271-6. doi: 10.1002/lsm.20760. |
| 18341419 | Background | Ng GY, Fung DT. The combined treatment effects of therapeutic laser and exercise on tendon repair. Photomed Laser Surg. 2008 Apr;26(2):137-41. doi: 10.1089/pho.2007.2145. |
| 9523774 | Background | Basford JR, Malanga GA, Krause DA, Harmsen WS. A randomized controlled evaluation of low-intensity laser therapy: plantar fasciitis. Arch Phys Med Rehabil. 1998 Mar;79(3):249-54. doi: 10.1016/s0003-9993(98)90002-8. |
| 24510123 | Background | Jastifer JR, Catena F, Doty JF, Stevens F, Coughlin MJ. Low-Level Laser Therapy for the Treatment of Chronic Plantar Fasciitis: A Prospective Study. Foot Ankle Int. 2014 Jun;35(6):566-571. doi: 10.1177/1071100714523275. |
| 25769363 | Background | Macias DM, Coughlin MJ, Zang K, Stevens FR, Jastifer JR, Doty JF. Low-Level Laser Therapy at 635 nm for Treatment of Chronic Plantar Fasciitis: A Placebo-Controlled, Randomized Study. J Foot Ankle Surg. 2015 Sep-Oct;54(5):768-72. doi: 10.1053/j.jfas.2014.12.014. Epub 2015 Mar 10. |
| 16309613 | Background | Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113. |
| 23137169 | Background | Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8. |
| 26257151 | Background | Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8. |
| 26610637 | Background | Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26. |
| 25184861 | Background | Redberg RF. Sham controls in medical device trials. N Engl J Med. 2014 Sep 4;371(10):892-3. doi: 10.1056/NEJMp1406388. No abstract available. |
| BG001 | The Usual Care + Sham (Placebo) PBM Group | Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment. Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time was calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | The Usual Care + Sham (Placebo) PBM Group | Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy was an inactive harmless treatment that was intended to mimic the active PBM treatment. Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball was warmed in the sham-PBMT. The device was turned on to make the red aiming beam visible, but the operator did not activate the switch to emit photons. |
|
|
| Primary | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up. | Posted | Mean | Standard Deviation | Percentage of function | 3-Week |
|
|
|
| Primary | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 62 enrolled participants completed 6-week follow-up and were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up. | Posted | Mean | Standard Deviation | Percentage of function | 6-week |
|
|
|
| Primary | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | 31 participants from the Usual Care + PBM Group and 4 participants from the Usual Care + Sham (Placebo) PBM Group completed 3-month randomized followed up. 26 randomized participants from the Usual Care + Sham (Placebo) PBM Group crossed over at 6-week follow-up and received the study intervention. | Posted | Mean | Standard Deviation | Percentage of function | 3-month |
|
|
|
| Primary | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | Posted | Mean | Standard Deviation | pain units on a scale | Baseline |
|
|
|
| Primary | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up. | Posted | Mean | Standard Deviation | pain units on a scale | 3-Week |
|
|
|
| Primary | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 62 enrolled participants were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up. | Posted | Mean | Standard Deviation | pain units on a scale | 6-Week |
|
|
|
| Primary | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | 31 participants from the Usual Care + PBM Group and 4 participants from the Usual Care + Sham (Placebo) PBM Group completed 3-month randomized followed up. 26 randomized participants from the Usual Care + Sham (Placebo) PBM Group crossed over at 6-week follow-up and received the study intervention. | Posted | Mean | Standard Deviation | pain units on a scale | 3-Month |
|
|
|
| Primary | Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | Posted | Mean | Standard Deviation | millimeters | Baseline |
|
|
|
| Primary | Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | 64 enrolled participants were analyzed for 3-week follow-up results. 3 participants that were assigned to the Usual Care + PBM Group and 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 3-week follow-up. | Posted | Mean | Standard Deviation | millimeters | 3-Week |
|
|
|
| Primary | Ultrasound Measurement (Plantar Fascial Thickness) | Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results. | 62 enrolled participants were analyzed for 6-week follow-up results. 2 participants that were assigned to the Usual Care + Sham (Placebo) PBM Group withdrew from the study prior to 6-week follow-up. | Posted | Mean | Standard Deviation | millimeters | 6-Week |
|
|
|
| Other Pre-specified | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | Posted | Mean | Standard Deviation | Percentage of function | 3-Week Cross-over |
|
|
|
| Other Pre-specified | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | Posted | Mean | Standard Deviation | Percentage of function | 6-Week Cross-over |
|
|
|
| Other Pre-specified | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | 3-Week Cross-over |
|
|
|
| Other Pre-specified | Pain Diary Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | 6-Week Cross-Over |
|
|
|
| Other Pre-specified | Foot and Ankle Ability Measure (FAAM) | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction. | Posted | Mean | Standard Deviation | Percentage of function | 3-month Cross-over |
|
|
|
| Other Pre-specified | Pain Diary and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes. | Posted | Mean | Standard Deviation | units on a scale | 3-month Cross-over |
|
|
|
| 0 |
| 31 |
| 2 |
| 31 |
| 1 |
| 31 |
| EG001 | The Usual Care + Sham (Placebo) PBM Group | Participants that were assigned to this group received Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment. Sham-Photobiomodualtion Therapy (Sham-PBMT): Sham-PBM treatment time was calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT was administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage was warmed in the sham-PBMT. The device was turned on, so the red aiming beam will be visible, but the operator did not activate the switch to emit photons. | 0 | 33 | 3 | 33 | 2 | 33 |
| EG002 | The Usual Care + Sham (Placebo) PBM Group With Cross-over to Intervention | Participants that were decided to cross-over to this group received active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments. Photobiomodulation Therapy (PBMT): Participants received PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments took approximately 5-10 minutes to administer at each session. Specific treatment parameters were based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants received 10 J/cm2, 25W output power, and the length of the treatment was dependent on treatment area (size). PBMT was administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members used the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback. | 0 | 26 | 2 | 26 | 0 | 26 |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | At the 3-week follow-up, the participant reported having an illness and was in quarantine. |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | At 6-week follow-up, participant reported having the flu. |
|
| Fluid in the Foot | Musculoskeletal and connective tissue disorders | Systematic Assessment | The participant had fluid in the foot and continues follow-up with a podiatrist who dis discovered the fluid. |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | At 3-week follow-up, participant reported that they went to ER due to significant amount of back pain. Participant continues to be monitored by the patient care management. |
|
| Hand Surgery | Surgical and medical procedures | Systematic Assessment | At baseline visit, participant reported having hand surgery. Participant continues recovery follow-up with their provider. |
|
|
| Skin reaction to unknown | Skin and subcutaneous tissue disorders | Systematic Assessment | After treatment 1, participant reported abnormal feeling on vein of right hand. |
|
| Scar from Dry Needling | Injury, poisoning and procedural complications | Systematic Assessment | As recorded during baseline, participant continues to have lump at arch location on both feet from dry needling procedure. |
|
Not provided
Not provided
| D013708 |
| Tendon Injuries |
| D014947 | Wounds and Injuries |