Clinical trial NCT04409353: Virtual Reality Therapy for Chronic Low Back Pain
Official title: Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Virtual Reality
Chronic Low Back Pain
Analgesia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-06-01
Enrollment: 413
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.

Detailed description: This is a randomized double-blind, placebo-controlled trial for individuals with chronic lower back pain. This study investigates the effect of at-home virtual reality (VR) pain reduction therapies on a set of outcome measures. The primary outcome is Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will enroll 360 analyzable participants into one of three VR therapy groups. Data collection will occur at home via personal computer or smartphone (iPhone/android), with baseline data collected one week before the intervention is mailed to the patient. Participants will have the VR headset for 90 days. Patients are also sent Fitbit smartwatches to track physical activity.

Eligibility criteria: Inclusion Criteria:

1. Able to provide consent to participate in research
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age 13 or older
4. An ongoing low back-pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months.
5. Ability to comprehend spoken and written English
6. Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email.

Exclusion Criteria:

1. Presents with a condition that interferes with virtual reality usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the virtual reality images or follow audio instructions
2. Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital
3. Received surgical procedure within the previous 8 weeks
4. Surgery is planned within the next 3 months
5. Is currently using a spinal cord stimulator
6. Has low back pain attributable to a recognizable, specific pathology, including spinal infection, cancer, fracture, or inflammatory spondylopathies, consistent with the NIH Task force on Research Standards for chronic low back pain
7. Previously participated in a virtual reality clinical trial

Primary outcomes:
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 30
timeFrame: From baseline to day 30
Secondary outcomes:
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) at Day 60 and Day 90
timeFrame: From baseline to day 60, from baseline to end of treatment at day 90
measure: Change From Baseline in Pain Catastrophizing Survey Short Form 6 (PCS SF-6) at Day 90.
timeFrame: From baseline to end of treatment at day 90
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Day 90
timeFrame: From baseline to end of treatment at day 90
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance to Day 90
timeFrame: From baseline to end of treatment at day 90
measure: Change From Baseline to Day 90 in Weekly Average Opioid Usage
timeFrame: From baseline to end of treatment at day 90
Other outcomes:
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 6b at Day 90
timeFrame: From baseline to end of treatment at day 90
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4 at Day 90
timeFrame: From baseline to end of treatment at day 90
measure: Biometric Data From Fitbit Charge 4 - Change in Average Daily Steps
timeFrame: From day 1 to end of treatment at day 90
measure: Biometric Data From Fitbit Charge 4 - Change in Average Sleep Score
timeFrame: From day 1 to end of treatment at day 90
measure: Change in Overall Effect of Treatment From Baseline to Day 90 Measured by Patient's Global Impression of Change (PGIC)
timeFrame: Measured at end of treatment at day 90
Locations:
city: Los Angeles
country: United States
facility: Samuel Eberlein
state: California
Study officials:
affiliation: Cedars-Sinai
name: Brennan Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birckhead B, Eberlein S, Alvarez G, Gale R, Dupuy T, Makaroff K, Fuller G, Liu X, Yu KS, Black JT, Ishimori M, Venuturupalli S, Tu J, Norris T, Tighiouart M, Ross L, McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 15;11(6):e050545. doi: 10.1136/bmjopen-2021-050545.