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Virtual Reality Treatment for Adults With Chronic Back Pain
NA trial testing Virtual Reality Therapy for Chronic Pain in Chronic Pain in 72 participants. Completed in 14 June 2021.
| Lead sponsor | CognifiSense Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 9 June 2020 |
| Primary completion | 13 April 2021 |
| Estimated completion | 14 June 2021 |
| Sites | 1 location across United States |
CognifiSense Inc.
Adults 21 to 70, any sex, with Chronic Pain or Back Pain Lower Back Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brief Pain Inventory-short form (BPI-SF). Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable.
| Group | Value | 95% CI |
|---|---|---|
| Therapy Group | -1.5 | ± 1.7 |
| Standard of Care (SOC) Group | -0.5 | ± 1.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Therapy Group | 3.68 | ± 4.7 |
| Standard of Care (SOC) Group | .89 | ± 3.5 |
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
| Group | Value | 95% CI |
|---|---|---|
| Therapy Group | -4.22 | ± 6.2 |
| Standard of Care (SOC) Group | -.37 | ± 4.5 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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