Trial Outcomes & Findings for Virtual Reality Treatment for Adults With Chronic Back Pain (NCT NCT04468074)
NCT ID: NCT04468074
Last Updated: 2022-06-23
Results Overview
Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
COMPLETED
NA
72 participants
Change from pre-treatment to post-treatment = 8 weeks.
2022-06-23
Participant Flow
Participants were recruited via online (e.g., social media) advertising between December 2019 and September 2020. The first participant was enrolled on June 9, 2020, and the last participant was enrolled in October 2020.
Of 1,346 applicants, 270 met inclusion criteria. Of these, 72 were enrolled in the study; however, 11 withdrew before start / randomization. 61 participants started the study (completed randomization). After a 2-week baseline period, participants were randomized into the Experimental and No Intervention Groups.
Participant milestones
| Measure |
Therapy Group
Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
1. An education session on the science behind chronic pain and a basic overview of the VR therapy.
2. A session to customize the VR experience to match the participant's own pain experience.
3. A training session on the use of the VR hardware and software.
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.
Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
|
Standard of Care (SOC) Group
The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Treatment for Adults With Chronic Back Pain
Baseline characteristics by cohort
| Measure |
Therapy Group
n=31 Participants
Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
1. An education session on the science behind chronic pain and a basic overview of the VR therapy.
2. A session to customize the VR experience to match the participant's own pain experience.
3. A training session on the use of the VR hardware and software.
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.
Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
|
Standard of Care (SOC) Group
n=30 Participants
The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
Outcome measures
| Measure |
Therapy Group
n=30 Participants
Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
1. An education session on the science behind chronic pain and a basic overview of the VR therapy.
2. A session to customize the VR experience to match the participant's own pain experience.
3. A training session on the use of the VR hardware and software.
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.
Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
|
Standard of Care (SOC) Group
n=30 Participants
The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
|
|---|---|---|
|
Change in Pain Intensity and Interference.
|
-1.5 units on a scale
Standard Deviation 1.7
|
-0.5 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline (average of survey data at beginning and end of a 2-week baseline period) and at the end of the 8 week therapy / control period.Population: Intent to Treat
Quality of Life (HRQoL SF-12) Questionnaire: yes / no questions and 3-point / 6-point Likert Scale questions; e.g., 1 = \[negative impact\] all of the time (worse outcome), 6 = \[negative impact\] none of the time. HRQoL results in two sub-scales / components (Physical and Mental). The mean of these was taken to result in a single value.
Outcome measures
| Measure |
Therapy Group
n=30 Participants
Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
1. An education session on the science behind chronic pain and a basic overview of the VR therapy.
2. A session to customize the VR experience to match the participant's own pain experience.
3. A training session on the use of the VR hardware and software.
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.
Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
|
Standard of Care (SOC) Group
n=30 Participants
The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
|
|---|---|---|
|
Change in Quality of Life.
|
3.68 units on a scale
Standard Deviation 4.7
|
.89 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Population: Intent to treat
Oswestry Low Back Pain Disability Questionnaire (OLBPD). 6-point Likert Scale questions on impact of pain on various life aspects; e.g., 1 = no negative impact, 6 = prevents normal activity (worse outcome). Participants completed questionnaire at the beginning and end of a 2-week baseline period and at the end of the 8 week therapy / control period. The starting values were the average of the two reported pain measures at the beginning and end of the baseline period
Outcome measures
| Measure |
Therapy Group
n=30 Participants
Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions:
1. An education session on the science behind chronic pain and a basic overview of the VR therapy.
2. A session to customize the VR experience to match the participant's own pain experience.
3. A training session on the use of the VR hardware and software.
Upon completion, participants begin using the VR therapy app at home once a day, 5 times a week (minimum), for a total of 8 weeks. The VR app contains different training exercises. A workbook provides a schedule and background on each of the training sessions.
Therapy Group participants may continue their other pain treatment regimes, and are asked to notify the research team of any changes.
Virtual Reality Therapy for Chronic Pain: 1) A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy 2) Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
|
Standard of Care (SOC) Group
n=30 Participants
The SOC Group (no-intervention) completes a daily pain survey. SOC Group participants are asked to maintain their pain treatment regimes, and are asked to notify the research team of any changes.
|
|---|---|---|
|
Change in Back Pain Disability.
|
-4.22 units on a scale
Standard Deviation 6.2
|
-.37 units on a scale
Standard Deviation 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.A questionnaire asking participants to list the type and dosage / frequency of medication and therapies the participant is using for their back pain and for any other medical conditions. The list and dosage of medications and the type and frequencies of therapies will be compared pre- and post-treatment (8-week interval) to assess change in other pain therapies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Patient Reported Outcomes Measurement Information System (PROMIS) short form for Sleep Disturbance: 8 items. 5-point Likert scales: 5 = not at all, 1 = very much (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Patient Reported Outcomes Measurement Information System (PROMIS) short form for Fatigue: 8 items. 5-point Likert scales: 1 = not at all, 5 = very much (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Survey of Pain Attitudes (SOPA) Short Form. 6-point Likert scale: 5 = This is very untrue for me, 1 = This is very true for me \[worse outcome\].
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true \[worse outcome\], 4 = exactly true.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Before Therapy Period begins (pre-treatment; after 2-week baseline).Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).Patient Global Impression of Change (PGIC). 7-point scale: 0 = no change (condition has got worse \[worst outcome\]), 10 = a great deal better, and a considerable improvement that has made all the difference.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from pre-treatment to post-treatment = 8 weeks.Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from pre-treatment to post-treatment = 8 weeks.Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).Questionnaire with 10 questions on usability of the VR device; 5-point Likert scale: 1 = strongly disagree, 5 = strongly agree (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study).Questionnaire with 14 questions about the participant's sense of presence in the virtual environment - based on IGP Presence Questionnaire; 5-point Likert scale: 1 = fully disagree, 5 = fully agree (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of the Therapy Period (post-treatment; approx. 10 weeks into study)Questionnaire with 10 questions about the participant's sense of embodiment in the virtual reality environment - based on the Gonzalez-Franko Embodiment Questionnaire; 7-point Likert scale from -3 = strongly disagree to +3 = strongly agree (worse outcome is a function of the question).
Outcome measures
Outcome data not reported
Adverse Events
Therapy Group
Standard of Care (SOC) Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place