Chronic Pain, Fibromyalgia, Musculoskeletal Pain, Virtual Reality
Conditions
Brief summary
The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.
Interventions
BEHAVIORALPain Rehabilitation Virtual Reality (PRVR)
Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).
BEHAVIORALStandard Physiotherapy Rehabilitation (SPR)
Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 10 to 17 years old * Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture) * English Language Proficiency
Exclusion criteria
* Significant cognitive impairment (e.g., brain injury) * Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality) * Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VR Duration of Use Per Week | Baseline to end of treatment across 6-8 weeks, on average | This outcome is to assess Feasibility, Acceptability, and Utility of VR. |
| Participant Rated Ease of Use | End of treatment at 6-8 weeks, on average | This outcome is to assess Feasibility, Acceptability, and Utility of VR. |
| Participant Rated Enjoyment | End of treatment at 6-8 weeks, on average | This outcome is to assess Feasibility, Acceptability, and Utility of VR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain-related Fear and Avoidance | Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment | Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes. |
| Physical Function: Lower Extremity | Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment | Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. Overall score range: Min=0, Max=80; lower score indicates greater disability/worse outcomes. |
| Physical Function: Upper Extremity | Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment | Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of upper extremity functioning. Overall score range: 0 to 80, with greater scores indicating increased upper extremity functioning. |
Countries
United States
Participant flow
Recruitment details
This was originally conceived as a two-arm study, with patients randomized 1:1 to Pain Rehabilitation Virtual Reality (PRVR) or Standard Physiotherapy Rehabilitation (SPR). Early in the study, the design was changed from that point all participants were allocated to the PRVR arm.
Participants by arm
| Arm | Count |
|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) PRVR participants are allocated a VR headset for use in their physical therapy sessions and as part of their home exercise program (approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks). | 28 |
| Standard Physiotherapy Rehabilitation (SPR) SPR participants are allocated to sessions that are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 as part of their home exercise program (8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks). | 6 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Single-arm portion | Adverse Event | 1 | 0 |
| Single-arm portion | Withdrawal by Subject | 1 | 0 |
| Two-arm, randomization portion | Lost to Follow-up | 0 | 1 |
| Two-arm, randomization portion | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Pain Rehabilitation Virtual Reality (PRVR) | Standard Physiotherapy Rehabilitation (SPR) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 6 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 5 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 3 Participants | 19 Participants |
| Region of Enrollment United States | 28 Participants | 6 Participants | 34 Participants |
| Sex/Gender, Customized Female | 12 Participants | 4 Participants | 16 Participants |
| Sex/Gender, Customized Male | 14 Participants | 0 Participants | 14 Participants |
| Sex/Gender, Customized Other | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 6 |
| other Total, other adverse events | 1 / 28 | 0 / 6 |
| serious Total, serious adverse events | 0 / 28 | 0 / 6 |
Outcome results
Primary
Participant Rated Ease of Use
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Time frame: End of treatment at 6-8 weeks, on average
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Ease of Use | Easy | 6 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Ease of Use | Not at all easy | 0 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Ease of Use | A little easy | 4 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Ease of Use | No Response | 2 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Ease of Use | Very easy | 13 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Ease of Use | No Response | 1 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Ease of Use | Very easy | 0 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Ease of Use | Easy | 3 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Ease of Use | A little easy | 0 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Ease of Use | Not at all easy | 0 Participants |
Primary
Participant Rated Enjoyment
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Time frame: End of treatment at 6-8 weeks, on average
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Enjoyment | Enjoyed | 10 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Enjoyment | Not at all | 0 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Enjoyment | Enjoyed a little | 5 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Enjoyment | No response | 5 Participants |
| Pain Rehabilitation Virtual Reality (PRVR) | Participant Rated Enjoyment | Enjoyed very much | 5 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Enjoyment | No response | 1 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Enjoyment | Enjoyed very much | 0 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Enjoyment | Enjoyed | 0 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Enjoyment | Enjoyed a little | 3 Participants |
| Standard Physiotherapy Rehabilitation (SPR) | Participant Rated Enjoyment | Not at all | 0 Participants |
Primary
VR Duration of Use Per Week
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Time frame: Baseline to end of treatment across 6-8 weeks, on average
Population: Participants who completed the protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | VR Duration of Use Per Week | 30.5 Minutes per week | Standard Deviation 39.52 |
| Standard Physiotherapy Rehabilitation (SPR) | VR Duration of Use Per Week | 17.0 Minutes per week | Standard Deviation 6.36 |
Secondary
Pain-related Fear and Avoidance
Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes.
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Population: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | Pain-related Fear and Avoidance | baseline | 21.00 score on a scale | Standard Deviation 8.67 |
| Pain Rehabilitation Virtual Reality (PRVR) | Pain-related Fear and Avoidance | end of treatment | 15.84 score on a scale | Standard Deviation 9.66 |
| Pain Rehabilitation Virtual Reality (PRVR) | Pain-related Fear and Avoidance | 3-month follow-up | 15.58 score on a scale | Standard Deviation 8.05 |
| Standard Physiotherapy Rehabilitation (SPR) | Pain-related Fear and Avoidance | baseline | 18.00 score on a scale | Standard Deviation 3.41 |
| Standard Physiotherapy Rehabilitation (SPR) | Pain-related Fear and Avoidance | end of treatment | 17.5 score on a scale | Standard Deviation 11.7 |
| Standard Physiotherapy Rehabilitation (SPR) | Pain-related Fear and Avoidance | 3-month follow-up | 22.00 score on a scale | Standard Deviation 13.64 |
Secondary
Physical Function: Lower Extremity
Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. Overall score range: Min=0, Max=80; lower score indicates greater disability/worse outcomes.
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Population: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Lower Extremity | 3-month follow-up | 66.76 score on a scale | Standard Deviation 11.73 |
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Lower Extremity | baseline | 54.64 score on a scale | Standard Deviation 14.13 |
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Lower Extremity | end of treatment | 63.24 score on a scale | Standard Deviation 11.57 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Lower Extremity | end of treatment | 57.75 score on a scale | Standard Deviation 16.64 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Lower Extremity | 3-month follow-up | 71.50 score on a scale | Standard Deviation 9.57 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Lower Extremity | baseline | 46.83 score on a scale | Standard Deviation 19.9 |
Secondary
Physical Function: Upper Extremity
Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of upper extremity functioning. Overall score range: 0 to 80, with greater scores indicating increased upper extremity functioning.
Time frame: Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Population: Participants who were enrolled in the study were analyzed at baseline and those who completed treatment and 3-month follow-up surveys were analyzed at those timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Upper Extremity | baseline | 64.07 score on a scale | Standard Deviation 12.84 |
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Upper Extremity | end of treatment | 67.48 score on a scale | Standard Deviation 10.42 |
| Pain Rehabilitation Virtual Reality (PRVR) | Physical Function: Upper Extremity | 3-month follow-up | 72.40 score on a scale | Standard Deviation 7.96 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Upper Extremity | baseline | 69.83 score on a scale | Standard Deviation 14.61 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Upper Extremity | end of treatment | 75.75 score on a scale | Standard Deviation 3.5 |
| Standard Physiotherapy Rehabilitation (SPR) | Physical Function: Upper Extremity | 3-month follow-up | 78.00 score on a scale | Standard Deviation 3.37 |