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The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skills-Based VR | Experimental | Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RelieveVRx | Device | Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale | Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Pre-intervention (week 0) only |
| Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale | Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Pre-intervention (week 0) only |
| Client Satisfaction Questionnaire | Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Post-intervention (week 8) only |
| System Usability Scale | Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent). | Post-intervention (week 8) only |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Impression of Change | The number of participants that improved "much or very much" or "minimally" on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program. | Post-intervention (week 8) only |
| Motion Sickness and Nausea |
| Measure | Description | Time Frame |
|---|---|---|
| Non-narcotic Pain Medications | Number of days that non-narcotic pain medications were taken in the last week. | Pre-intervention (week 0), Post-intervention (week 8) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan A Mace, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
No enrolled participants were excluded from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Skills-Based VR | Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Skills-Based VR | Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. RelieveVRx: Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale | Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Posted | Count of Participants | Participants | Pre-intervention (week 0) only |
|
Adverse event data were collected between baseline (Week 0) and post-test assessments (Week 9).
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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 | Skills-Based VR | Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brief, unrelated hospitalization | Infections and infestations | Non-systematic Assessment | ID 3 reported a 3-day inpatient hospitalization for a hip cyst unrelated to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild, related event due to "scuba" module | Psychiatric disorders | Non-systematic Assessment | ID 4 discontinued module 22 because they were "startled" by unexpectedly seeing a scuba diver in the immersive underwater environment. This was deemed a mild adverse event that was resolved by the participant skipping the module. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Mace | Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital | 617-724-7030 | rmace@mgh.harvard.edu |
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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 | Jun 22, 2023 | Jan 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001134 | Arm Injuries |
| D001265 | Athletic Injuries |
| D007718 | Knee Injuries |
| D014954 | Wrist Injuries |
| D016512 | Ankle Injuries |
| D018409 | Foot Injuries |
| D006230 | Hand Injuries |
| D005383 | Finger Injuries |
| D007869 | Leg Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent). |
| Post-intervention (week 8) only |
| Feasibility of Enrollment | We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent). | Throughout the study completion, approximately 1 year |
| Acceptability of Treatment | Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent). | Pre-intervention (week 0), Post-intervention (week 8) |
| Adherence to Pain Surveys | Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent). | Pre-intervention (week 0), Post-intervention (week 8) |
| Feasibility of Outcome Assessments | The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent). | Pre-intervention (week 0), Post-intervention (week 8) |
The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality).
| Pre-intervention (week 0), Post-intervention (week 8) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function). | Pre-intervention (week 0), Post-intervention (week 8) |
| Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). | Pre-intervention (week 0), Post-intervention (week 8) |
| Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). | Pre-intervention (week 0), Post-intervention (week 8) |
| Numerical Rating Scale (NRS) - Pain at Rest | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Numerical Rating Scale (NRS) - Pain With Activity | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing. | Pre-intervention (week 0), Post-intervention (week 8) |
| Pain Anxiety Scale (PASS) | The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety. | Pre-intervention (week 0), Post-intervention (week 8) |
| Pain Self-Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy). | Pre-intervention (week 0), Post-intervention (week 8) |
| Center for Epidemiologic Study of Depression (CESD) Scale | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms. | Pre-intervention (week 0), Post-intervention (week 8) |
| Cognitive and Affective Mindfulness Scale (CAMS) | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness. | Pre-intervention (week 0), Post-intervention (week 8) |
| Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale. | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
| Measure of Current Status (MOCS) | The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills. | Pre-intervention (week 0), Post-intervention (week 8) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Primary | Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale | Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Posted | Count of Participants | Participants | Pre-intervention (week 0) only |
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| Primary | Client Satisfaction Questionnaire | Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent). | Posted | Count of Participants | Participants | Post-intervention (week 8) only |
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| Primary | System Usability Scale | Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent). | Posted | Count of Participants | Participants | Post-intervention (week 8) only |
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| Secondary | Patient's Global Impression of Change | The number of participants that improved "much or very much" or "minimally" on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program. | Posted | Count of Participants | Participants | Post-intervention (week 8) only |
|
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| Secondary | Motion Sickness and Nausea | Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent). | Posted | Count of Participants | Participants | Post-intervention (week 8) only |
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| Secondary | Feasibility of Enrollment | We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent). | This benchmark indicates the number of participants enrolled out of total eligible. More participants were deemed eligible than the number that enrolled, ultimately making the overall number of participants greater than the number stated in the participant flow. | Posted | Count of Participants | Participants | Throughout the study completion, approximately 1 year |
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| Secondary | Acceptability of Treatment | Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent). | Posted | Count of Participants | Participants | Pre-intervention (week 0), Post-intervention (week 8) |
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| Secondary | Adherence to Pain Surveys | Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent). | Posted | Count of Participants | Participants | Pre-intervention (week 0), Post-intervention (week 8) |
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| Secondary | Feasibility of Outcome Assessments | The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent). | Posted | Count of Participants | Participants | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Non-narcotic Pain Medications | Number of days that non-narcotic pain medications were taken in the last week. | Out of 10 total participants, only 6 were included in the analysis for the Outcome Measure as they were taking non-narcotic medications during the study. | Posted | Mean | Standard Deviation | days per week | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance | The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality). | Posted | Mean | Standard Deviation | T-score | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function). | Posted | Mean | Standard Deviation | T-score | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). | Posted | Mean | Standard Deviation | Standardized subscale score | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized [(Actual raw score - lowest possible raw score/possible raw score range) *100], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). | Posted | Mean | Standard Deviation | Standardized subscale score | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Numerical Rating Scale (NRS) - Pain at Rest | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Numerical Rating Scale (NRS) - Pain With Activity | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Pain Anxiety Scale (PASS) | The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Pain Self-Efficacy Questionnaire (PSEQ) | The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy). | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Center for Epidemiologic Study of Depression (CESD) Scale | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Cognitive and Affective Mindfulness Scale (CAMS) | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| Other Pre-specified | Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale. | Posted | Mean | Standard Deviation | score on a scale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. |
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| Other Pre-specified | Measure of Current Status (MOCS) | The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0), Post-intervention (week 8) |
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| 0 |
| 10 |
| 1 |
| 10 |
| 1 |
| 10 |
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| fNIRS Movement | Psychiatric disorders | Non-systematic Assessment | RA observed ID8 becoming tearful while moving their injured limb during visit. RA assessed discomfort, and ID8 requested to proceed with protocol. ID8 did not display further signs of discomfort and confirmed interest in continuing the study. |
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