Chronic Low Back PainPhase 3VIBRANTNCT07158567
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
A Phase 3 study testing intermittent theta burst stimulation and LoveYourBrain Yoga Program in people with Chronic Low Back Pain and Musculoskeletal Pain, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Low Back Pain, Musculoskeletal Pain
- What is being tested?
- intermittent theta burst stimulation and LoveYourBrain Yoga Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2026to 31 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Epilepsy, active seizure disorder, personal history of a seizure or individuals with a family history of epilepsy or seizure in a first degree relative
- Current prescription of psychostimulants (e.g., amphetamines), anticholinergics, tricyclic antidepressants, and antipsychotics or other medications that may increase their risk of having seizures
Show all 14Show fewer
- Intracranial lesion
- History of ischemic or hemorrhagic stroke
- History of moderate to severe traumatic brain injury (TBI)
- History of or current psychosis not due to an external cause (e.g., due to illicit drug use)
- Other neurological conditions (e.g., neurodegenerative disorders)
- Active suicidal ideation with Columbia Suicide Severity Rating Scale (CSSRS) 3
- Are pregnant or nursing
- Within 12 weeks of a major surgery/operation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Howard S Gordon, MD, 312-569-7331, howard.gordon2@va.gov
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Gabriella G Amador, Gabriella.Amador@va.gov
William Wolf, PhD, (708) 202-5689, William.Wolf@va.gov
About this study
Official title: Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low Back PaiN Treatment: VIBRANT
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.
Read the detailed description
Significance to VA: Chronic low back pain (CLBP) is the leading cause of disability worldwide and the most common location of chronic pain among Veterans. Medications are the treatment mainstay for CLBP and yet >50% of chronic pain patients receiving medications are treatment resistant. Lack of pain relief from medications can lead to non-prescription opioid use, opioid use disorder, and Veteran death from opioid overdose, which occurs at a higher rate than US Civilians. This Merit will directly benefit Veterans and VA Services by developing a new, neuromodulatory, non-opioid neurorehabilitation treatment for Veterans with CLBP who do not find existing options to be effective or preferable. Innovation and Impact: Yoga is an activity, and mindfulness-based behavioral intervention and is safe and recommended for CLBP. Given the room for improvement of available treatments and considering the life-threatening opioid epidemic, building an evidence base for novel, precise, non-medication approaches for pain management has high impact for VA Healthcare. The non-invasive treatment transcranial magnetic stimulation (TMS) applied to the motor cortex (M1) reduces pain and has remote effects including neuromodulation of pain pathways. Intermittent theta burst stimulation (iTBS), a type of patterned, excitatory TMS, increases M1 excitability. iTBS can prime the brain to boost the impact of interventions provided during this window of enhanced excitability. By activating the M1 through iTBS prior to participation in an evidence-based yoga program, the investigators theorize that iTBS will boost the effects of yoga resulting in improvements in pain, function and quality of life and these improvements will be sustained. The purpose of this Merit project is to demonstrate efficacy and additive effect of combined iTBS and yoga (iTBS+yoga) and vs. yoga or iTBS alone on improving pain, function, analgesic use, self-efficacy, quality of life (QOL) and well-being among Veterans with CLBP. This Merit is a natural progression of a VA RR\&D-funded SPiRE suggesting that iTBS+yoga is safe, feasible, and acceptable among Veterans of all genders with CLBP and provides preliminary evidence of improvements from pre- to post-treatment in pain and QOL. The investigators will build on this evidence and add innovation by testing the additive effects of iTBS+yoga vs. yoga and iTBS each alone. For this Merit, the investigators will complete a randomized controlled trial among 3 groups of Veterans with CLBP receiving (1) active-iTBS+yoga, (2) sham-iTBS+yoga, or (3) active-iTBS alone. Specific Aims: Aim 1 will determine efficacy and sustainability of iTBS+yoga on pain, function, analgesic use, self-efficacy, QOL and well-being among Veterans with CLBP. Aim 2 will determine acceptability of iTBS+yoga for Veterans with CLBP. Exploratory Aim 3 will examine gender and common comorbidity measures as moderators of iTBS+yoga treatment effect. Methodology: The intervention will be provided in small group settings once a week for 6 weeks. Ac-tive- or sham-iTBS will be administered immediately prior to yoga. The investigators will be using an existing, evidence-based, manualized yoga program (LoveYourBrain Yoga). The investigators will collect outcome data related to pain, function, analgesic use, self-efficacy, QOL and well-being, as well as structural MRI data for iTBS neuronavigation. Path to Translation/Implementation: Completion of this Merit project will provide preliminary data for future applications focused on treatment responsiveness and a future larger scale multi-site pragmatic effectiveness study. This Merit project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with CLBP in need of non-opioid treatment options. TMS is now offered at over 50 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment.
- Conditions
- Chronic Low Back Pain, Musculoskeletal Pain
- Being tested
- intermittent theta burst stimulation, LoveYourBrain Yoga Program
- Keywords
- chronic low back pain, transcranial magnetic stimulation, TMS, neuromodulation, yoga, complementary and integrative health, musculoskeletal pain
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
Also called transcranial magnetic stimulation (TMS), Magventure
Transcranial 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 ProgramBehavioural
Also called yoga, hatha-based yoga
This 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.
| Study group | Role | What they receive |
|---|---|---|
| active-combined intermittent theta burst (iTBS)+yoga | Experimental | real or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class Receives: Device: intermittent theta burst stimulation; Behavioral: LoveYourBrain Yoga Program |
| sham-combined intermittent theta burst (iTBS)+yoga | Placebo comparator | fake, inactive or sham intermittent theta burst stimulation (designed to look, sound and feel like real or active stimulation) provided prior to participation in small group LoveYourBrain Yoga program class Receives: Device: intermittent theta burst stimulation; Behavioral: LoveYourBrain Yoga Program |
| active-combined intermittent theta burst (iTBS)alone | Active comparator | real or active intermittent theta burst stimulation alone (no yoga participation) Receives: Device: intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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-treatment
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.
Measured: 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-treatment
Secondary outcomes (7)
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.
Measured: 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-treatment
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.
Measured: 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-treatment
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.
Measured: 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-treatment
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.
Measured: 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-treatment
Veterans Rand 36 Item Health Survey (VR-36)
The VR-36 is a 36-item self-report measure of health-related quality of life. The VR-36 yields mental and physical component scores (MCS and PCS), with higher scores indicating better health-related quality of life.
Measured: 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-treatment
Pain Catastrophizing Scale (PCS)
The pain catastrophizing scale is a 13-item self report measure that asks about the types of thoughts and feelings associated with pain. The participant indicates the degree to which they think they have these thoughts and feelings when they are in pain on a scale of 0 "not at all" (best) to 4 "all the time" (worst). The minimal (best) possible score is a 0 and the maximum (worst) possible score is a 52. Item scores are summed into a total score (PCS-T) and 3 subscale scores rumination (PCS-R, Items 8,9,10 and 11), magnification (PCS-M, Items 6,7,13), and helplessness (PCS-H, Items 1,2,3,4,5, and 12). A total score above 30 indicates clinically relevant level of catastrophizing.
Measured: 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-treatment
Analgesic use
A medication inventory will be completed including opioids, other prescription and over the counter pain medications. The medication, dose, frequency and mode (e.g., oral, intramuscular injection, etc..) will be recorded. The investigators will use total dosage over the 6 week study intervention and 6 month follow up period of medications as the outcome.
Measured: 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-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Oct 2026 (estimated)
- Primary completion1 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single, blind, randomized, 3 parallel group design: (1) active-iTBS+yoga, (2) sham-iTBS+yoga, and (3) active-iTBS alone
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy A Herrold, PhD BA, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158567
- Sponsor's protocol ID
- RRD2-003-24W
- Other IDs
- 1 I01 RD000449-01A1
- Acronym
- VIBRANT
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low Back PaiN Treatment: VIBRANT
- ClinicalTrials.gov ID
- NCT07158567
- Acronym / sponsor ID
- VIBRANT / RRD2-003-24W
- Conditions
- Chronic Low Back Pain, Musculoskeletal Pain
- Keywords
- chronic low back pain, transcranial magnetic stimulation, TMS, neuromodulation, yoga, complementary and integrative health, musculoskeletal pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Significance to VA: Chronic low back pain (CLBP) is the leading cause of disability worldwide and the most common location of chronic pain among Veterans. Medications are the treatment mainstay for CLBP and yet >50% of chronic pain patients receiving medications are treatment resistant. Lack of pain relief from medications can lead to non-prescription opioid use, opioid use disorder, and Veteran death from opioid overdose, which occurs at a higher rate than US Civilians. This Merit will directly benefit Veterans and VA Services by developing a new, neuromodulatory, non-opioid neurorehabilitation treatment for Veterans with CLBP who do not find existing options to be effective or preferable. Innovation and Impact: Yoga is an activity, and mindfulness-based behavioral intervention and is safe and recommended for CLBP. Given the room for improvement of available treatments and considering the life-threatening opioid epidemic, building an evidence base for novel, precise, non-medication approaches for pain management has high impact for VA Healthcare. The non-invasive treatment transcranial magnetic stimulation (TMS) applied to the motor cortex (M1) reduces pain and has remote effects including neuromodulation of pain pathways. Intermittent theta burst stimulation (iTBS), a type of patterned, excitatory TMS, increases M1 excitability. iTBS can prime the brain to boost the impact of interventions provided during this window of enhanced excitability. By activating the M1 through iTBS prior to participation in an evidence-based yoga program, the investigators theorize that iTBS will boost the effects of yoga resulting in improvements in pain, function and quality of life and these improvements will be sustained. The purpose of this Merit project is to demonstrate efficacy and additive effect of combined iTBS and yoga (iTBS+yoga) and vs. yoga or iTBS alone on improving pain, function, analgesic use, self-efficacy, quality of life (QOL) and well-being among Veterans with CLBP. This Merit is a natural progression of a VA RR\&D-funded SPiRE suggesting that iTBS+yoga is safe, feasible, and acceptable among Veterans of all genders with CLBP and provides preliminary evidence of improvements from pre- to post-treatment in pain and QOL. The investigators will build on this evidence and add innovation by testing the additive effects of iTBS+yoga vs. yoga and iTBS each alone. For this Merit, the investigators will complete a randomized controlled trial among 3 groups of Veterans with CLBP receiving (1) active-iTBS+yoga, (2) sham-iTBS+yoga, or (3) active-iTBS alone. Specific Aims: Aim 1 will determine efficacy and sustainability of iTBS+yoga on pain, function, analgesic use, self-efficacy, QOL and well-being among Veterans with CLBP. Aim 2 will determine acceptability of iTBS+yoga for Veterans with CLBP. Exploratory Aim 3 will examine gender and common comorbidity measures as moderators of iTBS+yoga treatment effect. Methodology: The intervention will be provided in small group settings once a week for 6 weeks. Ac-tive- or sham-iTBS will be administered immediately prior to yoga. The investigators will be using an existing, evidence-based, manualized yoga program (LoveYourBrain Yoga). The investigators will collect outcome data related to pain, function, analgesic use, self-efficacy, QOL and well-being, as well as structural MRI data for iTBS neuronavigation. Path to Translation/Implementation: Completion of this Merit project will provide preliminary data for future applications focused on treatment responsiveness and a future larger scale multi-site pragmatic effectiveness study. This Merit project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with CLBP in need of non-opioid treatment options. TMS is now offered at over 50 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- single, blind, randomized, 3 parallel group design: (1) active-iTBS+yoga, (2) sham-iTBS+yoga, and (3) active-iTBS alone
| Arm | Type | Receives |
|---|---|---|
| active-combined intermittent theta burst (iTBS)+yoga | Experimental | Device: intermittent theta burst stimulation, Behavioral: LoveYourBrain Yoga Programreal or active intermittent theta burst stimulation provided prior to participation in small group LoveYourBrain Yoga program class |
| sham-combined intermittent theta burst (iTBS)+yoga | Placebo comparator | Device: intermittent theta burst stimulation, Behavioral: LoveYourBrain Yoga Programfake, inactive or sham intermittent theta burst stimulation (designed to look, sound and feel like real or active stimulation) provided prior to participation in small group LoveYourBrain Yoga program class |
| active-combined intermittent theta burst (iTBS)alone | Active comparator | Device: intermittent theta burst stimulationreal or active intermittent theta burst stimulation alone (no yoga participation) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
- Epilepsy, active seizure disorder, personal history of a seizure or individuals with a family history of epilepsy or seizure in a first degree relative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulationAlso: transcranial magnetic stimulation (TMS), MagventureTranscranial 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. | Device | active-combined intermittent theta burst (iTBS)+yoga, active-combined intermittent theta burst (iTBS)alone, sham-combined intermittent theta burst (iTBS)+yoga |
| LoveYourBrain Yoga ProgramAlso: yoga, hatha-based yogaThis 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. | Behavioural | active-combined intermittent theta burst (iTBS)+yoga, sham-combined intermittent theta burst (iTBS)+yoga |
Primary outcome
Brief Pain Inventory - Pain Severity
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-treatment
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.
Brief Pain Inventory - Pain Interference
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-treatment
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.
7 secondary outcomes
PROMIS Pain Interference - Short Form 6b
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-treatment
PROMIS Physical Function with Mobility Aid
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-treatment
Wellbeing Signs Tool
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-treatment
Pain Self-Efficacy Questionnaire
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-treatment
Veterans Rand 36 Item Health Survey (VR-36)
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-treatment
Pain Catastrophizing Scale (PCS)
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-treatment
Analgesic use
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-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- The NICHD Data and Specimen Hub (DASH) is a centralized resource that allows researchers to share and access de-identified dataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy A Herrold, PhD BA principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intermittent theta burst stimulation and LoveYourBrain Yoga Program in people with Chronic Low Back Pain and Musculoskeletal Pain, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy A Herrold, PhD BA ((708) 202-5867, amy.herrold@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Pain Severity (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-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.