Pain, Acute, Pain, Chronic
Conditions
Keywords
virtual reality, transcutaneous electrical nerve stimulation, analgesia
Brief summary
This study will test the effectiveness of an evidence-based, multi-modal, digital pain-reduction kit as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
Interventions
DEVICEDigital Pain Reduction Kit
A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
DEVICEActive Control
An active control TENS unit used to reduce acute localized pain.
Sponsors
Travelers
Samsung
AppliedVR Inc.
Bayer
Hollywog
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, age 18 or older 4. Seeking care for a musculoskeletal injury 5. Experiencing pain greater than 3 out of 10 on a visual analog scale 6. English or Spanish speaking 7. Owns a compatible Android or iOS smartphone device (excluding tablets)
Exclusion criteria
1. Unable to understand the goals of the study due to cognitive difficulty 2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units) 3. Pregnant (contraindication for TENS unit) 4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software 5. Hypersensitivity to flashing light or motion 6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Physical Function Short Form 8b | 60 days | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Pain Interference Short Form 8a | 60 days | PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average. |
| Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | 60 days | The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item (During the past seven days, how much did your pain affect your productivity while you were working?) with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item(During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?) with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities. |
| Patient Satisfaction Questionnaire (PSQ) 18 | 60 days | Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction. |
| Binary, Self-reported Opioid Use | 60 days | Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids). |
Countries
United States
Participant flow
Recruitment details
Initial Deployment: Inpatient trauma only, in-person recruitment of CSMC trauma patients with no opioid prescription. 3/28/2018 - 10/31/2018 Inpatient trauma + Pain Clinic. In-person recruitment of cLBP patients without opioid prescription at single CSMC pain specialty clinic. 11/1/2018 - 12/31/2018 Revised: Inpatient Trauma + Pain Clinic. Patients with opioid prescription allowed to participate. 1/1/2019 - 4/23/2019 Revised: Pain Clinic only, recruitment fully remote. 4/23/2019 - End
Pre-assignment details
Of 1156 patients assessed for eligibility, 245 met criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Digital Pain Reduction Kit Participants in the experimental arm will be assigned the digital pain reduction kit consisting of a transcutaneous electrical nerve stimulation unit to be used as needed and a virtual reality headset to be used as needed or at least once a day. Remote clinical support is provided for patients who volunteer information to be viewed by clinicians.
Digital Pain Reduction Kit: A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain. | 67 |
| Active Control Participants in the active control arm will receive standard of care as provided by their physician in addition to a transcutaneous electrical nerve stimulation unit.
Active Control: An active control TENS unit used to reduce acute localized pain. | 69 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Inpatient Trauma Only | Lost to Follow-up | 3 | 12 |
| Inpatient Trauma Only | socioeconomic burden | 1 | 0 |
| Inpatient Trauma+Pain Clinic | Disease burden | 1 | 0 |
| Inpatient Trauma+Pain Clinic | Lost to Follow-up | 2 | 5 |
| Inpatient Trauma+Pain Clinic | Unhappy with allocation | 0 | 2 |
| Inpatient Trauma+Pain Clinic, no Opioid | Disease burden | 1 | 0 |
| Inpatient Trauma+Pain Clinic, no Opioid | Lost to Follow-up | 0 | 5 |
| Pain Clinic Only, Fully Remote | Disease burden | 6 | 5 |
| Pain Clinic Only, Fully Remote | EMR | 0 | 1 |
| Pain Clinic Only, Fully Remote | Language barrier | 0 | 1 |
| Pain Clinic Only, Fully Remote | Lost to Follow-up | 27 | 47 |
Baseline characteristics
| Characteristic | Digital Pain Reduction Kit | Total | Active Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 16 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 120 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 21 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 115 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PROMIS - Physical Function Short Form 8b | 34.5 units on a scale STANDARD_DEVIATION 6.5 | 36.60 units on a scale STANDARD_DEVIATION 6.69 | 38.6 units on a scale STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 28 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) White | 38 Participants | 84 Participants | 46 Participants |
| Sex: Female, Male Female | 44 Participants | 92 Participants | 48 Participants |
| Sex: Female, Male Male | 23 Participants | 44 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 142 |
| other Total, other adverse events | 0 / 103 | 2 / 142 |
| serious Total, serious adverse events | 0 / 103 | 0 / 142 |
Outcome results
Primary
PROMIS - Physical Function Short Form 8b
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Time frame: 60 days
Population: Participants with a week 1 response.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Pain Reduction Kit | PROMIS - Physical Function Short Form 8b | 34.5 units on a scale | Standard Deviation 6.5 |
| Active Control | PROMIS - Physical Function Short Form 8b | 38.6 units on a scale | Standard Deviation 6.3 |
Comparison: We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.p-value: 0.11195% CI: [-4.15, 0.43]Mixed Models Analysis
Secondary
Binary, Self-reported Opioid Use
Investigators will examine opioid utilization using binary self-reported opioid use (e.g. 0=did not use opioidss;1=used opioids).
Time frame: 60 days
Population: Includes all respondents to both primary outcome week 1 and opioid surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Pain Reduction Kit | Binary, Self-reported Opioid Use | 11 Participants |
| Active Control | Binary, Self-reported Opioid Use | 15 Participants |
Comparison: We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.p-value: 0.85295% CI: [0.07, 9.07]Regression, Logistic
Secondary
Patient Satisfaction Questionnaire (PSQ) 18
Patient Satisfaction Questionnaire (PSQ) 18 which includes questions in 3 relevant domains: general satisfaction, communication, and accessibility of care. All subscales are scored so that high scores reflect satisfaction with medical care. Each domain averages responses to items with a range of 1-5, with 5 indicating the highest satisfaction.
Time frame: 60 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Digital Pain Reduction Kit | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ General Satisfaction | 3.25 score on a scale | Standard Deviation 0.15 |
| Digital Pain Reduction Kit | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ Communication | 3.55 score on a scale | Standard Deviation 1.02 |
| Digital Pain Reduction Kit | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ Access | 3.2 score on a scale | Standard Deviation 0.85 |
| Active Control | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ General Satisfaction | 3.49 score on a scale | Standard Deviation 0.12 |
| Active Control | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ Communication | 3.84 score on a scale | Standard Deviation 0.8 |
| Active Control | Patient Satisfaction Questionnaire (PSQ) 18 | PSQ Access | 3.52 score on a scale | Standard Deviation 0.1 |
Comparison: For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.p-value: 0.46795% CI: [-0.23, 0.49]t-test, 2 sided
Secondary
PROMIS - Pain Interference Short Form 8a
PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. A single Pain interference score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. By comparison, a Pain Interference T-score of 40 is one SD lower pain than average.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Pain Reduction Kit | PROMIS - Pain Interference Short Form 8a | 64.8 score on a scale | Standard Deviation 7.4 |
| Active Control | PROMIS - Pain Interference Short Form 8a | 63.2 score on a scale | Standard Deviation 7.2 |
Comparison: We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.p-value: 0.61295% CI: [-1.84, 3.12]Mixed Models Analysis
Secondary
Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)
The WPAI:LBP was created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Lower Back Pain. The WPAI:LBP productivity loss subscale consists of a single item (During the past seven days, how much did your pain affect your productivity while you were working?) with a 0-10 response scale where 0 indicates pain had no effect, and 10 indicates pain completely prevented work. The presenteeism sub-scale consists of a comparison two items, yielding percent of hours missed due to pain. Finally, the activity impairment subscale consists of one item(During the past seven days, how much did your pain affect your ability to do your regular daily activities, other than work at a job?) with a 0-10 response scale where 0 indicated pain had no effect, and 10 indicated pain completely prevented daily activities.
Time frame: 60 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Digital Pain Reduction Kit | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Presenteism (%hours) | 26.9 score on a scale | Standard Deviation 22.6 |
| Digital Pain Reduction Kit | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Productivity | 7.3 score on a scale | Standard Deviation 2.3 |
| Digital Pain Reduction Kit | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Activity Impairment | 7.1 score on a scale | Standard Deviation 2.8 |
| Active Control | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Presenteism (%hours) | 26.4 score on a scale | Standard Deviation 16.8 |
| Active Control | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Productivity | 7.1 score on a scale | Standard Deviation 1.9 |
| Active Control | Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0) | WPAI: Activity Impairment | 7.0 score on a scale | Standard Deviation 2.5 |
Comparison: For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.p-value: 0.8795% CI: [-5.51, 4.66]t-test, 2 sided
Comparison: For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.p-value: 0.78795% CI: [-0.54, 0.54]t-test, 2 sided
Comparison: For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.p-value: 0.56995% CI: [-0.88, 0.48]t-test, 2 sided