Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorVA Office of Research and Development
About this trial
The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit project will directly benefit Veterans and VA Services by demonstrating efficacy of a new, non-medication treatment for Veterans with CLBP in need of non-opioid treatment options. Neuromodulation including iTBS is now offered at over 50 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-medication treatment for Veterans with CLBP is of great need given the high prevalence of CLBP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1 month stability in pain management strategies
Can read and speak English
Able to participate in strengthening, stretching, range of motion exercise via yoga as determined by study physician
Chronic Low Back Pain (CLBP): pain in the low back that persists for >6 months and is of moderate to severe intensity with a score of >5 on specific items on the Brief Pain Inventory (BPI) demonstrating disability of at least 20% on the Oswestry Disability Index (ODI)
Disqualifiers
Contraindications to combined intermittent theta burst (iTBS)/transcranial magnetic stimulation (TMS), (e.g., epilepsy, psychotic spectrum disorders [i.e. bipolar, schizophrenia], history of anoxic brain injury)
Moderate to severe heart disease
Contraindications to MRI (e.g., claustrophobia, implanted ferromagnetic device such as pacemaker or cardiac defibrillator)
Pain believed to be associated with cardiac or ischemic conditions
Trial design
Design model
Parallel
Treatments tested in this trial
intermittent theta burst stimulation
DeviceTranscranial magnetic stimulation (TMS) is a non-invasive neuromodulatory treatment. TMS has been FDA cleared since 2008 for treatment resistant depression. It is now FDA cleared for a few other indications including migraine. Magnetic pulses are delivered through a coil placed on the scalp and when the magnetic field reaches brain cells, it changes to an electric current that can increase or decrease excitability depending on the treatment parameters. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS only takes 3 minutes to deliver and is theorized to induce a window of neuroplasticity that lasts at least 1 hour. The Magventure with Magoption x100 Stimulator and associated coil the investigators are using can be set to deliver active (real) or sham (fake or inactive) TMS. The sham device is designed to look, sound and feel like real TMS.
LoveYourBrain Yoga Program
BehavioralThis yoga program is evidence-based, standardized and manualized. It is developed by the LoveYourBrain Foundation (www.loveyourbrain.com). Each yoga session includes 10 min of breathing exercises, 45 min of gentle yoga or stretching exercises, 15 min of guided meditation, and 20 min of facilitated discussion with psychoeducation, detailed in a manual to ensure standardization of program content across time and instructors.
Treatment groups
213 Participants
are divided into 3 treatment groupsGroup A: active-combined intermittent theta burst (iTBS)+yogaExperimental treatment 2 interventions
Group B: sham-combined intermittent theta burst (iTBS)+yogaPlacebo comparator 2 interventions
Group C: active-combined intermittent theta burst (iTBS)aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Brief Pain Inventory - Pain Severity
The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items related to pain severity and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 40.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment2
Brief Pain Inventory - Pain Interference
The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. t has 7 main items related to pain interference and each item is scored on a scale of 0 to 10 with 0 meaning "Does not interfere", and 10 meaning "Completely Interferences". Minimum (best) score would be 0 and maximum (worst) score would be 70.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatmentSecondary outcomes
1
PROMIS Pain Interference - Short Form 6b
The Pain Interference - Short Form 6b is a 6-item self-report measure of pain interference. Each item is scored on a scale of 1 "not at all" (better) to 5 "very much" (worse). Minimum (best) possible raw score would be 6 and maximum (worst) possible raw score would be 30. Raw scores are converted with a conversion chart from the manual to a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment2
PROMIS Physical Function with Mobility Aid
The Physical Function with Mobility Aid is an 11-item self-report measure of daily life functioning and mobility. Each item is scored on a scale of 5 "without any difficulty" (best) to 1 "unable to do" (worst). The maximum (best) possible raw score is 55 and the minimum (worst) possible raw score is 11. Raw scores are converted with a conversion chart from the manual to a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment3
Wellbeing Signs Tool
The well being signs tool is a self-report measure that starts with an open ended question of "what matters most to you in your life right now?" followed by 3 items on a scale of 0 to 10 with 0 being the worst and 10 being the best wellbeing. The minimum (worst) possible score is 0 with the maximum (best) possible score of 30.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatment4
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire is a self-report measure that asks about confidence in doing things at the present time despite the pain. It has 2 items and each item is has a scale of 0 to 6 with 0 being "not at all confident" (worst) and 6 being "completely confident" (best). The total minimum (worst) possible raw score would be 0 and total maximum (best) possible raw score would be 12. A person with a score of 5 or less might be considered in need of help with their confidence in functioning in the presence of their pain. A score of 8 or higher reflects a desirable level of pain self-efficacy or confidence in functioning in the presence of pain.
Time frame
Baseline (Pre-intervention, Endpoint (after last iTBS+yoga treatment, approximately 6 weeks), Follow-Up at 1 week, 2 weeks, 6 weeks and 6 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov
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