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Completed

NCT Number: NCT05552430

Virtual Reality for Pain in Acute Orthopedic Injuries

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatient adults in the Level 1 Trauma Center
  • Age 18 or older
  • Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation
  • Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase).
  • Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40
  • Has access to internet (Wi-Fi or wireless)
  • Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for >6 weeks
  • Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for >6 weeks)
  • Cleared by orthopedic surgeon for study participation

Exclusion criteria

  • Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR
  • Medical condition predisposing to nausea or dizziness.
  • Hypersensitivity to flashing light or motion.
  • Vision or severe hearing impairment.
  • Injury to eyes, face, or neck that impedes comfortable use of virtual reality
  • Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy)
  • Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery)
  • Current or prior untreated mental illness, substance use disorder, or suicidal ideation
  • Self-reported pregnancy
  • Currently in litigation or under Workman's Comp
  • Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months

Treatment and study plan

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.

Primary outcomes

  1. Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale

    Time frame: Pre-intervention (week 0) only

    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).

  2. Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale

    Time frame: Pre-intervention (week 0) only

    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).

  3. Client Satisfaction Questionnaire

    Time frame: Post-intervention (week 8) only

    Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).

  4. System Usability Scale

    Time frame: Post-intervention (week 8) only

    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).

Secondary outcomes

  1. Patient's Global Impression of Change

    Time frame: Post-intervention (week 8) only

    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.

  2. Motion Sickness and Nausea

    Time frame: Post-intervention (week 8) only

    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).

  3. Feasibility of Enrollment

    Time frame: Throughout the study completion, approximately 1 year

    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).

  4. Acceptability of Treatment

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  5. Adherence to Pain Surveys

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  6. Feasibility of Outcome Assessments

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent).

Other outcomes

  1. Non-narcotic Pain Medications

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    Number of days that non-narcotic pain medications were taken in the last week.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance

    Time frame: 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).

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  4. Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  5. Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  6. Numerical Rating Scale (NRS) - Pain at Rest

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  7. Numerical Rating Scale (NRS) - Pain With Activity

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  8. Pain Catastrophizing Scale (PCS)

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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.

  9. Pain Anxiety Scale (PASS)

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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.

  10. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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).

  11. Center for Epidemiologic Study of Depression (CESD) Scale

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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.

  12. Cognitive and Affective Mindfulness Scale (CAMS)

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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.

  13. Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  14. Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  15. Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  16. Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale

    Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.

    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.

  17. Measure of Current Status (MOCS)

    Time frame: Pre-intervention (week 0), Post-intervention (week 8)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Physical and Psychological Measures of Pain in Acute Orthopedic Injuries: Use of At-home Virtual Reality

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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