Chronic Low Back PainNCT02552992
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
A study testing Yoga and Self-Directed Mind-Body Program in people with Chronic Low Back Pain, run by University of California, San Francisco.
Trial summary
This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Yoga and Self-Directed Mind-Body Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain lasting > 6 months
- Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).
- English language fluency
Who cannot join
- BMI > 40
- Inability to provide informed consent
- Recent diagnosis of abdominal aneurism
- Recent diagnosis of metastatic cancer
- Recent diagnosis of discitis
- Recent diagnosis of disk disease
Show all 32Show fewer
- Recent diagnosis of spinal stenosis
- Recent diagnosis of spondylolisthesis
- Recent diagnosis of infectious cause of back pain
- Recent diagnosis of fracture of vertebra
- Recent diagnosis of Fibromyalgia
- Recent diagnosis of rheumatoid arthritis
- Recent diagnosis of ankylosing spondylitis
- Recent diagnosis of paralysis
- Pregnancy
- Prior or planned back surgery
- Blindness or severe vision problems
- Deafness or severe hearing problems
- Bipolar or manic depression and not taking medication
- Major depression
- Psychoses (major)
- a substance abuse condition
- Dementia
- Unable to get up and down from the floor
- Involvement in a lawsuit related to back pain
- Lack of transportation
- Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
- Currently (within the past 3 months) using yoga classes for more than 15 minutes per week
- Inability to be contacted by phone or email
- no computer access
- schedule does not allow for participation in classes/home practice
- planning to move out of town or take a long vacation during the period of the study
About this study
This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability. This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice.
- Conditions
- Chronic Low Back Pain
- Being tested
- Yoga, Self-Directed Mind-Body Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Self-Directed Mind-Body ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Yoga Classes | Experimental | Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording. Receives: Behavioral: Yoga |
| Self-Directed Mind-Body Program | Active comparator | Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living. Receives: Behavioral: Self-Directed Mind-Body Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Roland Morris Disability Questionnaire
Measured: 6 months
Secondary outcomes (2)
Change in Numeric Rating Scale for Pain
Measured: 6 months
Change in Pain Medication Usage Survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionDec 2016
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 University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Zion Health Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552992
- Sponsor's protocol ID
- UCSFCHR14-14148
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2015
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
- ClinicalTrials.gov ID
- NCT02552992
- Acronym / sponsor ID
- UCSFCHR14-14148
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mount Zion Health Fund
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability. This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Classes | Experimental | Behavioral: YogaStudy Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording. |
| Self-Directed Mind-Body Program | Active comparator | Behavioral: Self-Directed Mind-Body ProgramStudy Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic low back pain lasting > 6 months
- Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).
- English language fluency
Key exclusion criteria (32 listed)
- BMI > 40
- Inability to provide informed consent
- Recent diagnosis of abdominal aneurism
- Recent diagnosis of metastatic cancer
- Recent diagnosis of discitis
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 |
|---|---|---|
| Yoga | Behavioural | Yoga Classes |
| Self-Directed Mind-Body Program | Behavioural | Self-Directed Mind-Body Program |
Primary outcome
Change in Roland Morris Disability Questionnaire
Time frame: 6 months
2 secondary outcomes
Change in Numeric Rating Scale for Pain
Time frame: 6 months
Change in Pain Medication Usage Survey
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Self-Directed Mind-Body Program in people with Chronic Low Back Pain, run by University of California, San Francisco.
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 3 inclusion and 32 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: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Roland Morris Disability Questionnaire (time frame: 6 months). 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 19 Nov 2019.