Virtual Reality Treatment for Adults With Chronic Back Pain
Study Details
Study Description
Brief Summary
Participants with chronic back pain will complete an online eligibility questionnaire. After signing a consent form, eligible participants enter a two-week baseline period ("Baseline Period") during which they complete a daily pain survey. Following the Baseline Period all participants complete an MRI scan. After the MRI, scan participants are randomized into a treatment group ("Therapy Group") or a no-intervention group ("Standard of Care Group" or "SOC Group") with a ratio of 1:1 (treatment:SOC). Therapy Group participants receive education about chronic pain. They also participate in sessions to personalize their Virtual Reality (VR) experience, and to complete training on the use of the VR hardware and software. Therapy Group participants complete the treatment for 8 weeks ("Therapy Period"), after which they return the VR equipment. All participants take a second MRI scan approximately 8-weeks after the first MRI; for the Therapy Group this is at the end of the Therapy Period. After the Therapy Period, Therapy Group participants continue to complete daily pain surveys during a two-week follow-up period ("Follow-Up Period"). All participants complete self-reported clinical outcomes and behavioral measures surveys before and after the Baseline Period, 4 weeks after the first MRI (for Therapy Group this is mid-way through the Therapy Period), and before and after the Follow-Up Period. For Therapy Group participants the study ends with the final surveys and an exit interview at the end of the Follow-up Period. Study Extension (Add-on): SOC Group participants may receive the treatment after the Follow-Up period. Those who elect to do so will complete the same set of surveys as the Therapy Group did during the treatment phase; however, since there is no comparison group, data from this study extension is not used in the main outcomes analyses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapy Group Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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. |
Device: Virtual Reality Therapy for Chronic Pain
A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy
Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises
Other Names:
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Change in Pain Intensity and Interference. [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.
Secondary Outcome Measures
- Change in Quality of Life. [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.]
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.
- Change in Back Pain Disability. [Change from pre-treatment to post-treatment = 8 weeks.]
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
Other Outcome Measures
- Change in Pain Bothersomeness. [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).
- Change in Medications and Therapies. [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.
- Change in Pain Catastrophizing. [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).
- Change in Fear of Pain. [Change from pre-treatment to post-treatment = 8 weeks.]
Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome).
- Change in Fear of Movement. [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).
- Change in Sleep Quality. [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).
- Change in Fatigue Symptoms. [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).
- Change in Depression. [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).
- Change in Pain Attitudes. [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].
- Change in Self-efficacy. [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.
- Expectations of Treatment Success. [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).
- Impression of Treatment Success. [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.
- Change in Optimism [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).
- Change in Emotion Regulation. [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).
- Change in Mindfulness. [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.
- Change in Pain Coping Strategies. [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).
- Change in Structural (Brain) MRI. [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.
- Change in Resting-State Functional MRI. [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.
- Change in Diffusion Tensor Imaging (DTI) MRI. [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.
- Assessment of Usability of VR Device. [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).
- Assessment of Sense of Presence in the VR Environment. [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).
- Assessment of Sense of Embodiment in the VR Environment. [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants aged 21 to 70 with Chronic Back Pain.
-
Chronic Back Pain will be defined according to criteria established by recent NIH task force. Pain duration must be ≥ 3 months, with back pain being an ongoing problem for at least half the days of last 6 months; i.e., either pain every day for past 3 months, or half or more of the days for past 6+ months.
-
Subjects must rate pain intensity at ≥ 4/10 on Brief Pain Inventory (average pain over the last week).
-
Participants must also be comfortable and able to communicate via email, text message, or phone in English. Participants must also be comfortable using a video-conferencing service such as Zoom to complete the on-line sessions.
Exclusion Criteria:
-
Applicants, who are pregnant, planning pregnancy, or breastfeeding
-
Back pain associated with compensation / litigation within 1 year.
-
Leg pain greater than back pain (suggests neuropathic pain; may be less responsive to psychological therapy).
-
Chronic pain other than chronic back pain.
-
Diagnoses of schizophrenia, multiple personality dissociative identity disorder.
-
History of major depressive disorder not controlled with medication or other conditions that produce significant cognitive or emotional disability.
-
History of substance abuse.
-
Inability to undergo MRI (determined at screening; see XVI: Risks to Participants).
-
Any clinically significant unstable medical abnormality or acute or chronic disease of cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems; including: history of cardiovascular disease or issues (e.g., recent heart attack), stroke; brain surgery, or brain tumor; Diabetes; cancer (last 12 months); diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus; polymyositis; or Cauda Equina syndrome.
-
History of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime except pediatric febrile seizures.
-
History of vertigo, dizziness, susceptibility to motion sickness
-
History of head injury within 6 months,
-
Unexplained, unintended weight loss of 'â• 20 lbs in past year.
-
Self-reported history of (digital) eye strain or computer vision syndrome.
-
Unable or unwilling to meet study attendance requirements.
-
MRI contraindications as determined by MRI safety screen (e.g., pregnancy, metal in body, claustrophobia, using the standard screen conducted by the MRI imaging facility).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado, Boulder | Boulder | Colorado | United States | 80301 |
Sponsors and Collaborators
- CognifiSense Inc.
- University of Colorado, Boulder
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Marta Ceko, Ph.D., University of Colorado, Boulder
- Principal Investigator: Lynn Webster, MD, CognifiSense Inc.
- Principal Investigator: Tassilo Baeuerle, CognifiSense Inc.
Study Documents (Full-Text)
More Information
Publications
- 19-0526
- 1R43NR017575-01A1
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group |
|---|---|---|
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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. |
| Period Title: Overall Study | ||
| STARTED | 31 | 30 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group | Total |
|---|---|---|---|
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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 of all reporting groups |
| Overall Participants | 31 | 30 | 61 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.1
(10)
|
33.5
(9.2)
|
34.2
(9.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
48.4%
|
15
50%
|
30
49.2%
|
| Male |
16
51.6%
|
15
50%
|
31
50.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
9.7%
|
2
6.7%
|
5
8.2%
|
| Not Hispanic or Latino |
24
77.4%
|
23
76.7%
|
47
77%
|
| Unknown or Not Reported |
4
12.9%
|
5
16.7%
|
9
14.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
6.5%
|
0
0%
|
2
3.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
3.3%
|
1
1.6%
|
| Black or African American |
1
3.2%
|
2
6.7%
|
3
4.9%
|
| White |
28
90.3%
|
26
86.7%
|
54
88.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
3.3%
|
1
1.6%
|
Outcome Measures
| Title | Change in Pain Intensity and Interference. |
|---|---|
| Description | Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group |
|---|---|---|
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [units on a scale] |
-1.5
(1.7)
|
-0.5
(1.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Therapy Group, Standard of Care (SOC) Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Quality of Life. |
|---|---|
| Description | 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. |
| Time Frame | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat |
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group |
|---|---|---|
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [units on a scale] |
3.68
(4.7)
|
.89
(3.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Therapy Group, Standard of Care (SOC) Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0159 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 2.79 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Back Pain Disability. |
|---|---|
| Description | 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 |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat |
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group |
|---|---|---|
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [units on a scale] |
-4.22
(6.2)
|
-.37
(4.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Therapy Group, Standard of Care (SOC) Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0066 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Net) |
| Estimated Value | -3.85 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Pain Bothersomeness. |
|---|---|
| Description | Pain Bothersomeness Scale. 0-10 scale: 0 = not at all bothersome; 10 = extremely bothersome) (Source: Cherkin et al. 2016). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Medications and Therapies. |
|---|---|
| Description | 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. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Pain Catastrophizing. |
|---|---|
| Description | Pain Catastrophizing Questionnaire (PCS). 4-point Likert scale: = not at all, 4 = all the time (worse outcome). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Fear of Pain. |
|---|---|
| Description | Fear of Pain Questionnaire. 5-point Likert scale: = not at all, 5 = extreme (worse outcome). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Fear of Movement. |
|---|---|
| Description | Tampa Scale of Kinesiophobia (TSK). 4-point Likert scale: = strongly disagree, 4 = strongly agree (worse outcome). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Sleep Quality. |
|---|---|
| Description | 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). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Fatigue Symptoms. |
|---|---|
| Description | 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). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Depression. |
|---|---|
| Description | Patient Reported Outcomes Measurement Information System (PROMIS) short form for Depression: 8 items. 5-point Likert scales: 5 = never, 1 = always (worse outcome). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Pain Attitudes. |
|---|---|
| Description | 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]. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Self-efficacy. |
|---|---|
| Description | General Self-Efficacy Scale. 4-point Likert scale: 1 = not at all true [worse outcome], 4 = exactly true. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Expectations of Treatment Success. |
|---|---|
| Description | Expectations of Treatment Success Survey. 0 to 10 scale: 0 = none, 10 = most (best outcome). |
| Time Frame | Before Therapy Period begins (pre-treatment; after 2-week baseline). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Impression of Treatment Success. |
|---|---|
| Description | 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. |
| Time Frame | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Optimism |
|---|---|
| Description | Life Orientation Test (LOT-R). 5-point Likert scale: 0 = strongly disagree, 4 = strongly agree (worse outcome is a function of the question). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Emotion Regulation. |
|---|---|
| Description | Emotion Regulation Questionnaire (ERQ). 7-point Likert scale: 1 = strongly disagree, 7 = strongly agree (worse outcome is a function of the question). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Mindfulness. |
|---|---|
| Description | Mindful Attention Awareness Scale (MAAS). 7-point Likert scale: 0 = almost always (worse outcome), 7 = almost never. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Pain Coping Strategies. |
|---|---|
| Description | Coping Strategies Questionnaire (CSQ). 7-point Likert scale: 0 = never do, 7 = always do that (worse outcome is a function of the question). |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Structural (Brain) MRI. |
|---|---|
| Description | Acquire 2 structural MRI brain scans (before and after treatment) to measure brain gray matter changes due to treatment. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Resting-State Functional MRI. |
|---|---|
| Description | Acquire 2 functional MRI brain scans (before and after treatment), during which the participants will rest, to measure functional brain changes due to treatment. |
| Time Frame | from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change in Diffusion Tensor Imaging (DTI) MRI. |
|---|---|
| Description | Acquire 2 DTI MRI scans (before and after treatment) to measure brain white matter changes due to treatment. |
| Time Frame | Change from pre-treatment to post-treatment = 8 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment of Usability of VR Device. |
|---|---|
| Description | 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). |
| Time Frame | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment of Sense of Presence in the VR Environment. |
|---|---|
| Description | 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). |
| Time Frame | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment of Sense of Embodiment in the VR Environment. |
|---|---|
| Description | 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). |
| Time Frame | At the end of the Therapy Period (post-treatment; approx. 10 weeks into study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 8 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Therapy Group | Standard of Care (SOC) Group | ||
| Arm/Group Description | Therapy Group participants start the treatment period with three 1 ½ hour introductory sessions: An education session on the science behind chronic pain and a basic overview of the VR therapy. A session to customize the VR experience to match the participant's own pain experience. 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 | 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. | ||
All Cause Mortality |
||||
| Therapy Group | Standard of Care (SOC) Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/30 (0%) | ||
Serious Adverse Events |
||||
| Therapy Group | Standard of Care (SOC) Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/30 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Therapy Group | Standard of Care (SOC) Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/30 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Marta Ceko |
|---|---|
| Organization | University of Colorado, Boulder |
| Phone | 443-835-6587 |
| Marta.Ceko@colorado.edu |
- 19-0526
- 1R43NR017575-01A1