Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and beneficiaries 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 (PBM), or low level laser therapy, 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. Unfortunately, previous studies of PBM for treatment of plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on its clinical effectiveness.
SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the clinical effectiveness of photobiomodulation in conjunction with and compared to usual care to improve function and decrease pain and in patients. 3. Assess the difference between two photobiomodulation dose parameters in conjunction with and compared to usual care for plantar fasciitis treatment.
DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6 month) follow-up, measures of foot function and pain will be collected for analysis. The proposed methods will allow the study team to establish if PBM accelerates recovery compared to usual care, as well as determining the optimal dose for future trials comparing PBM to other, more invasive, therapies for plantar fasciitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants will complete 6 weeks of stretching and cryotherapy |
|
| PBM 10 Watts | Experimental | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks |
|
| PBM 25 Watts | Experimental | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretching | Other | Daily foot and ankle stretching protocol |
|
| 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 plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-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). A higher score means a better outcome. | Baseline, 3 weeks, and 6 weeks |
| Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS). This 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. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. | Baseline, 3 weeks, and 6 weeks |
| Foot and Ankle Ability Measure (FAAM) Long-term | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-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). A higher score means a better outcome. | 3 months and 6 months |
| Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Defense and Veterans Pain Rating Scale (DVPRS). This 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. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. | 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Dorsiflexion | Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group. | % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ann K Ketz, PhD | LRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landstuhl Regional Medical Center | Landstuhl | APO AE | 09180 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants will complete 6 weeks of stretching and cryotherapy Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching |
| FG001 | PBM 10 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output |
| FG002 | PBM 25 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation High Power: Photobiomodulation treatment with 25W power output |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants will complete 6 weeks of stretching and cryotherapy Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching |
| BG001 | PBM 10 Watts |
| 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 plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-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). A higher score means a better outcome. | 7 withdrew from Usual Care group; 2 each from treatment groups. | Posted | Mean | 95% Confidence Interval | percentage of total score | Baseline, 3 weeks, and 6 weeks |
|
Adverse event data were collected during the six weeks of active study treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants will complete 6 weeks of stretching and cryotherapy Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness and Tingling | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Grade 2, probably not related to treatment |
No sham group to neutralize bias related to intervention; Not able to compare the usual care group to the intervention group in long term follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Kobiela Ketz | Landstuhl Regional Medical Center | 8022656263 | annketz@gmail.com |
Not provided
| 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 | Apr 8, 2019 | Feb 5, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2016 | Mar 28, 2019 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D007053 | Ice |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cryotherapy | Other | Daily cryotherapy in conjunction with stretching |
|
|
| Photobiomodulation Low Power | Device | Photobiomodulation treatment with 10W power output |
|
|
| Photobiomodulation High Power | Device | Photobiomodulation treatment with 25W power output |
|
|
| Subject has New Medical Status |
|
| Physician Decision |
|
Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output
| BG002 | PBM 25 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation High Power: Photobiomodulation treatment with 25W power output |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Count of Participants | Participants |
|
| Number of Months with Plantar Fasciitis or Plantar Heel Pain | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | A numerical schema for skin color based on melanin pigment, which participants self-select. There is no inherent value to the numbers. 1- skin ivory, always freckles, always burns/peels, never tans; 2 - skin fair or pale, usually freckles, burns/peels often, rarely tans; 3 - skin fair to beige, might freckle, burns on occasion, sometimes tans; 4 - skin olive or light brown, doesn't really freckle, burns rarely, tans often; 5 - skin dark brown, rarely freckles, almost never burns, always tans; 6 - skin deeply pigmented dark brown, never freckles, never burns, always tans darkly. | Count of Participants | Participants |
|
| OG001 | PBM 10 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output |
| OG002 | PBM 25 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation High Power: Photobiomodulation treatment with 25W power output |
|
|
| Primary | Defense and Veterans Pain Rating Scale (DVPRS) | Defense and Veterans Pain Rating Scale (DVPRS). This 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. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. | 7 withdrew from Usual Care group; 2 each from treatment groups. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 weeks, and 6 weeks |
|
|
|
| Primary | Foot and Ankle Ability Measure (FAAM) Long-term | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-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). A higher score means a better outcome. | Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures. | Posted | Mean | 95% Confidence Interval | percentage of total score | 3 months and 6 months |
|
|
|
| Primary | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Defense and Veterans Pain Rating Scale (DVPRS). This 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. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. | Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months and 6 months |
|
|
|
| Secondary | Ankle Dorsiflexion | Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group. | Posted | Mean | Standard Error | percentage of change over time | % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | PBM 10 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output | 0 | 38 | 0 | 38 | 1 | 38 |
| EG002 | PBM 25 Watts | Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks Stretching: Daily foot and ankle stretching protocol Cryotherapy: Daily cryotherapy in conjunction with stretching Photobiomodulation High Power: Photobiomodulation treatment with 25W power output | 0 | 38 | 0 | 38 | 0 | 38 |
|
Not provided
Not provided
Not provided
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D053685 | Laser Therapy |
| D010789 | Phototherapy |
|
| Week 6 24 Hour Pain |
|
| Baseline Activity Interference |
|
| Week 3 Activity Interference |
|
| Week 6 Activity Interferece |
|
| Baseline Sleep Interference |
|
| Week 3 Sleep Interference |
|
| Week 6 Sleep Interference |
|
| Baseline Mood Interference |
|
| Week 3 Mood Interference |
|
| Week 6 Mood Interference |
|
| Baseline Stress Interference |
|
| Week 3 Stress Interference |
|
| Week 6 Stress Interference |
|
| 3 Months Sports Subscale |
|
|
| 6 Months ADL Subscale |
|
|
| 6 Months Sports Subscale |
|
|
| Month 6 24 Hour Pain |
|
|
| Month 3 Activity Interference |
|
|
| Month 6 Activity Interference |
|
|
| Month 3 Sleep Interference |
|
|
| Month 6 Sleep Interference |
|
|
| Month 3 Mood Interference |
|
|
| Month 6 Mood Interference |
|
|
| Month 3 Stress Interference |
|
|
| Month 6 Stress Interference |
|
|
|
| % change baseline to week 6 |
|