Back Pain Lower Back ChronicBack to HealthNCT01343927
Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations
A study testing Weekly yoga classes, Individual physical therapy treatment and Education in people with Back Pain Lower Back Chronic, run by Boston Medical Center at 8 sites in United States.
Trial summary
A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Weekly yoga classes, Individual physical therapy treatment and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to Dec 2014
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current non-specific low back pain persisting for at least 12 weeks
- 18-64 years old
- Mean low back pain intensity for the previous week of 4 or greater on a 0 to 10 numerical rating scale (0=no pain to 10=worst possible pain)
- English fluency sufficient to follow treatment instructions and answer survey questions.
Who cannot join
- New CLBP treatments started within the previous month or anticipated to begin in the next 3 months
- Known pregnancy
- Inability to understand English at a level necessary to understand treatment instructions and survey questions
- Previous back surgery or back fracture
- Specific CLBP pathologies (including spinal canal stenosis, severe scoliosis, spondylolisthesis, ankylosing spondylitis, large herniated disk)
- Severe or progressive neurological deficits
Show all 15Show fewer
- Sciatica pain equal to or greater than back pain
- Active or recent cervical radiculopathy
- Active or planned worker's compensation, disability, or personal injury claims
- Lack of consent
- Significant participation in yoga or physical therapy in the last six months
- Has read The Back Pain Helpbook or the Back Book in the previous six months
- The principal investigator judges the participant to be unable to participate in the study due to serious medical and/or psychiatric comorbidities
- Has previously participated in the Yoga Dosing Study or the Physical Therapy Pilot
- Plans to move out of the Boston area in the next year
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boston Medical Center
Boston, Massachusetts, 02118
South End Community Health Center
Boston, Massachusetts, 02118
Dimock Health Center
Boston, Massachusetts, 02119
Dorchester House MultiService Center
Dorchester, Massachusetts, 02112
Codman Square Health Center
Dorchester, Massachusetts, 02124
Upham's Corner Health Center
Dorchester, Massachusetts, 02125
Greater Roslindale Medical and Dental Center
Roslindale, Massachusetts, 02131
South Boston Community Health Center
South Boston, Massachusetts, 02127
About this study
Official title: Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.
Read the detailed description
Chronic low back pain (CLBP) affects 5-10% of U.S. adults annually and disproportionately impacts individuals from minority and low income backgrounds due to disparities in access and treatment. Our previous Yoga Dosing Study of 95 adults with chronic low back pain recruited from Boston Medical Center and affiliated community health centers showed that both once per week and twice per week yoga classes for 12 weeks were similarly effective for reducing pain and improving back related function. We concluded that due to the superior convenience and lower cost of once per week compared to twice per week classes, a once per week yoga protocol was optimal for the current study. Evidence from multiple studies supports a moderate benefit in CLBP for exercise therapy individually-delivered by a physical therapist. Moreover, physical therapy is the most common, reimbursed, non-pharmacologic treatment recommended by physicians for CLBP. However, no studies to date have done a head-to-head comparison of the effectiveness of yoga and physical therapy for CLBP. To ultimately reduce disparities in CLBP for minority populations, patients, providers, and health insurers need to know how a complementary therapy such as yoga compares in effectiveness to more well established treatments such as physical therapy (PT) and education. If yoga is superior to education and has similar effectiveness as PT but costs less with greater adherence, the potential therapeutic and economic implications would be substantial. Alternatively, if yoga is inferior, this information will help guide better treatment decisions and reduce unnecessary expenditures on inferior treatments.
The present study (Back to Health) is a 52 week comparative effectiveness randomized controlled trial of once per week yoga classes, individually delivered physical therapy (PT), and education for chronic low back pain (CLBP) in 320 individuals from predominantly minority backgrounds recruited from Boston Medical Center and affiliated community health centers. The 52 week trial starts with an initial 12 week Treatment Phase followed by a 40 week Maintenance Phase. Back to Health has the following three specific aims:
- In the 12 week Treatment Phase, we will enroll 320 adults with chronic low back pain(CLBP) from predominately low-income minority communities and compare the effectiveness (co-primary endpoints pain and function) between (1) a standardized protocol of one yoga class per week; (2) a standardized exercise therapy protocol based on an evidence-based clinical guidelines individually delivered by a physical therapist; and (3) an educational book on self-care for CLBP
- For adults with CLBP who have completed the initial 12 week yoga or physical therapy(PT) Treatment Phases, compare effectiveness (co-primary endpoints pain and function)between patients participating in a structured yoga maintenance program, a structured PT maintenance program, or no structured maintenance program.
- Determine the cost-effectiveness of yoga, PT, and education for adults with CLBP at 12 weeks, 6 months, 9 months, and one year from three perspectives: society, third party payers, and the participant.
For the 12 week Treatment Phase, participants are randomized in a 2:2:1 ratio into (1) a standardized once per week hatha yoga class supplemented by home practice; (2) a standardized evidence-based exercise therapy protocol individually delivered by a physical therapist and supplemented by home practice; and (3) education delivered through a self-care book. The study co-primary endpoints are mean pain intensity over the previous week measured on a 11 point numerical rating scale and back-specific function measured using the 23 point modified Roland Morris Disability Questionnaire. We hypothesize: (1) yoga will be noninferior to physical therapy; and (2) both yoga and physical therapy will be superior to education.
For the 40 week Maintenance Phase, yoga participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance yoga program or no maintenance yoga program. Similarly, physical therapy participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance PT program or no maintenance PT program. Education participants will be encouraged to continue to review and follow the recommendations of their educational materials. We hypothesize: (1) maintenance yoga will be non-inferior to maintenance PT; (2) maintenance yoga and maintenance PT will be superior to no yoga maintenance and no PT maintenance, respectively; and (3) maintenance yoga and maintenance PT will both be superior to education.
We will also take advantage of a comprehensive integrated set of patient databases, self-report cost data, and study records to compare at 3 months, 6 months, 9 months, and one year the cost-effectiveness of yoga, physical therapy, and education from three perspectives: society,third-party payer, and the participant. Qualitative data from interviews and focus groups will add subjective detail to complement quantitative data.
Results from the Back to Health Study will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Weekly yoga classes, Individual physical therapy treatment, Education
- Keywords
- Chronic low back pain, Community health center, Yoga, Physical therapy, Minority populations, Health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly yoga classesBehavioural
Manualized 12-week Hatha yoga intervention developed specifically for chronic low back pain in adult populations; classes meet once each week at community-based locations.
Individual physical therapy treatmentBehavioural
12 weeks of fifteen individual physical therapy sessions divided as follows: Week 1 intake appointment; weeks 2-4 two appointments per week; weeks 5-12 one appointment per week.
EducationBehavioural
Participants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Active comparator | 12 weeks of weekly yoga classes plus 40 weeks of either drop-in classes or home practice. Receives: Behavioral: Weekly yoga classes |
| Physical Therapy | Active comparator | 15 individual physical therapy treatment sessions over 12 weeks plus 40 weeks with either 5 booster sessions or home practice. Receives: Behavioral: Individual physical therapy treatment |
| Education | Active comparator | "The Back Pain Helpbook" which gives exercises and tips for self-care pain management. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Average Pain intensity in previous week
Intensity of pain in previous week as measured on a 10 point numerical scale (0-10).
Measured: 12 wks
Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability
Utilize modified 23-point scale standardized Roland Morris questionnaire to asses back pain specific disability.
Measured: 12 wks
Secondary outcomes (5)
Change from baseline in Pain Medication use in the previous week
Specific self-reported pain medication use in previous week.
Measured: 12wks
Satisfaction with assigned intervention at 12 weeks
Self-reported satisfaction with intervention using 5-point Likert scale from very dissatisfied to very satisfied
Measured: 12 wks
Global improvement in back pain at 12 weeks
Self-reported rating of global improvement since start of study using 7-point Likert scale from extremely worsened to extremely improved
Measured: 12wks
Change from Baseline for Health related Quality of Life using SF-36 survey
Use standardized Quality of life SF-36 questionnaire.
Measured: 12wks
Work productivity
Use standardized Work Productivity and Activity Impairment questionnaire to assess employment status and productivity
Measured: 12wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Robert B Saper, MD, MPH, Principal investigator, Boston University School of Medicine/ Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343927
- Sponsor's protocol ID
- H-29779
- Other IDs
- R01AT005956
- Acronym
- Back to Health
- Status last verified
- Feb 2019
- First submitted
- 20 Apr 2011
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27.
PubMed 19943573Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
PubMed 23878604Joyce C, Kelly KC, Gurnani S, Sherman KJ, Roseen EJ, Saper RB. "In Class We Were All One." A Qualitative Exploration of Yoga and Educational Interventions for Predominantly Low-Income and Minority Adults with Chronic Low Back Pain. J Integr Complement Med. 2022 Nov;28(11):870-877. doi: 10.1089/jicm.2022.0557. Epub 2022 Aug 1.
PubMed 35914101Joyce CT, Chernofsky A, Lodi S, Sherman KJ, Saper RB, Roseen EJ. Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain. J Orthop Sports Phys Ther. 2022 Jul;52(7):470-483. doi: 10.2519/jospt.2022.10813. Epub 2022 May 18.
PubMed 35584010Marshall A, Joyce CT, Tseng B, Gerlovin H, Yeh GY, Sherman KJ, Saper RB, Roseen EJ. Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain. Pain Med. 2022 Apr 8;23(4):834-843. doi: 10.1093/pm/pnab318.
PubMed 34698869Joyce C, Roseen EJ, Keysor JJ, Gross KD, Culpepper L, Saper RB. Can Yoga or Physical Therapy for Chronic Low Back Pain Improve Depression and Anxiety Among Adults From a Racially Diverse, Low-Income Community? A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jun;102(6):1049-1058. doi: 10.1016/j.apmr.2021.01.072. Epub 2021 Feb 5.
PubMed 33556352Roseen EJ, Gerlovin H, Felson DT, Delitto A, Sherman KJ, Saper RB. Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial. Pain Med. 2021 Feb 4;22(1):165-180. doi: 10.1093/pm/pnaa153.
PubMed 32662833Berlowitz J, Hall DL, Joyce C, Fredman L, Sherman KJ, Saper RB, Roseen EJ. Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial. Pain Med. 2020 Oct 1;21(10):2529-2537. doi: 10.1093/pm/pnaa150.
PubMed 32500130Roseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.
PubMed 31667747Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
PubMed 28631003Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
PubMed 24568299
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations (Back to Health)
- ClinicalTrials.gov ID
- NCT01343927
- Acronym / sponsor ID
- Back to Health / H-29779
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Chronic low back pain, Community health center, Yoga, Physical therapy, Minority populations, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Apr 2011 (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.
A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.
Detailed description
Chronic low back pain (CLBP) affects 5-10% of U.S. adults annually and disproportionately impacts individuals from minority and low income backgrounds due to disparities in access and treatment. Our previous Yoga Dosing Study of 95 adults with chronic low back pain recruited from Boston Medical Center and affiliated community health centers showed that both once per week and twice per week yoga classes for 12 weeks were similarly effective for reducing pain and improving back related function. We concluded that due to the superior convenience and lower cost of once per week compared to twice per week classes, a once per week yoga protocol was optimal for the current study. Evidence from multiple studies supports a moderate benefit in CLBP for exercise therapy individually-delivered by a physical therapist. Moreover, physical therapy is the most common, reimbursed, non-pharmacologic treatment recommended by physicians for CLBP. However, no studies to date have done a head-to-head comparison of the effectiveness of yoga and physical therapy for CLBP. To ultimately reduce disparities in CLBP for minority populations, patients, providers, and health insurers need to know how a complementary therapy such as yoga compares in effectiveness to more well established treatments such as physical therapy (PT) and education. If yoga is superior to education and has similar effectiveness as PT but costs less with greater adherence, the potential therapeutic and economic implications would be substantial. Alternatively, if yoga is inferior, this information will help guide better treatment decisions and reduce unnecessary expenditures on inferior treatments.
The present study (Back to Health) is a 52 week comparative effectiveness randomized controlled trial of once per week yoga classes, individually delivered physical therapy (PT), and education for chronic low back pain (CLBP) in 320 individuals from predominantly minority backgrounds recruited from Boston Medical Center and affiliated community health centers. The 52 week trial starts with an initial 12 week Treatment Phase followed by a 40 week Maintenance Phase. Back to Health has the following three specific aims:
- In the 12 week Treatment Phase, we will enroll 320 adults with chronic low back pain(CLBP) from predominately low-income minority communities and compare the effectiveness (co-primary endpoints pain and function) between (1) a standardized protocol of one yoga class per week; (2) a standardized exercise therapy protocol based on an evidence-based clinical guidelines individually delivered by a physical therapist; and (3) an educational book on self-care for CLBP
- For adults with CLBP who have completed the initial 12 week yoga or physical therapy(PT) Treatment Phases, compare effectiveness (co-primary endpoints pain and function)between patients participating in a structured yoga maintenance program, a structured PT maintenance program, or no structured maintenance program.
- Determine the cost-effectiveness of yoga, PT, and education for adults with CLBP at 12 weeks, 6 months, 9 months, and one year from three perspectives: society, third party payers, and the participant.
For the 12 week Treatment Phase, participants are randomized in a 2:2:1 ratio into (1) a standardized once per week hatha yoga class supplemented by home practice; (2) a standardized evidence-based exercise therapy protocol individually delivered by a physical therapist and supplemented by home practice; and (3) education delivered through a self-care book. The study co-primary endpoints are mean pain intensity over the previous week measured on a 11 point numerical rating scale and back-specific function measured using the 23 point modified Roland Morris Disability Questionnaire. We hypothesize: (1) yoga will be noninferior to physical therapy; and (2) both yoga and physical therapy will be superior to education.
For the 40 week Maintenance Phase, yoga participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance yoga program or no maintenance yoga program. Similarly, physical therapy participants will be re-randomized in a 1:1 ratio to either a structured ongoing maintenance PT program or no maintenance PT program. Education participants will be encouraged to continue to review and follow the recommendations of their educational materials. We hypothesize: (1) maintenance yoga will be non-inferior to maintenance PT; (2) maintenance yoga and maintenance PT will be superior to no yoga maintenance and no PT maintenance, respectively; and (3) maintenance yoga and maintenance PT will both be superior to education.
We will also take advantage of a comprehensive integrated set of patient databases, self-report cost data, and study records to compare at 3 months, 6 months, 9 months, and one year the cost-effectiveness of yoga, physical therapy, and education from three perspectives: society,third-party payer, and the participant. Qualitative data from interviews and focus groups will add subjective detail to complement quantitative data.
Results from the Back to Health Study will help determine whether it is justifiable for yoga, currently a "complementary" therapy, to become an acceptable "mainstream" treatment for chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Active comparator | Behavioral: Weekly yoga classes12 weeks of weekly yoga classes plus 40 weeks of either drop-in classes or home practice. |
| Physical Therapy | Active comparator | Behavioral: Individual physical therapy treatment15 individual physical therapy treatment sessions over 12 weeks plus 40 weeks with either 5 booster sessions or home practice. |
| Education | Active comparator | Behavioral: Education"The Back Pain Helpbook" which gives exercises and tips for self-care pain management. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Current non-specific low back pain persisting for at least 12 weeks
- 18-64 years old
- Mean low back pain intensity for the previous week of 4 or greater on a 0 to 10 numerical rating scale (0=no pain to 10=worst possible pain)
- English fluency sufficient to follow treatment instructions and answer survey questions.
Key exclusion criteria (15 listed)
- New CLBP treatments started within the previous month or anticipated to begin in the next 3 months
- Known pregnancy
- Inability to understand English at a level necessary to understand treatment instructions and survey questions
- Previous back surgery or back fracture
- Specific CLBP pathologies (including spinal canal stenosis, severe scoliosis, spondylolisthesis, ankylosing spondylitis, large herniated disk)
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 |
|---|---|---|
| Weekly yoga classesManualized 12-week Hatha yoga intervention developed specifically for chronic low back pain in adult populations; classes meet once each week at community-based locations. | Behavioural | Yoga |
| Individual physical therapy treatment12 weeks of fifteen individual physical therapy sessions divided as follows: Week 1 intake appointment; weeks 2-4 two appointments per week; weeks 5-12 one appointment per week. | Behavioural | Physical Therapy |
| EducationParticipants given "The Back Pain Helpbook" and periodic newsletters addressing back pain and self care. | Behavioural | Education |
Primary outcome
Change from Baseline in Average Pain intensity in previous week
Time frame: 12 wks
Intensity of pain in previous week as measured on a 10 point numerical scale (0-10).
Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability
Time frame: 12 wks
Utilize modified 23-point scale standardized Roland Morris questionnaire to asses back pain specific disability.
5 secondary outcomes
Change from baseline in Pain Medication use in the previous week
Time frame: 12wks
Satisfaction with assigned intervention at 12 weeks
Time frame: 12 wks
Global improvement in back pain at 12 weeks
Time frame: 12wks
Change from Baseline for Health related Quality of Life using SF-36 survey
Time frame: 12wks
Work productivity
Time frame: 12wks
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 7 Feb 2019.
- Background: PubMed 19943573Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27.
- Background: PubMed 23878604Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
- Derived from this study: PubMed 35914101Joyce C, Kelly KC, Gurnani S, Sherman KJ, Roseen EJ, Saper RB. "In Class We Were All One." A Qualitative Exploration of Yoga and Educational Interventions for Predominantly Low-Income and Minority Adults with Chronic Low Back Pain. J Integr Complement Med. 2022 Nov;28(11):870-877. doi: 10.1089/jicm.2022.0557. Epub 2022 Aug 1.
- Derived from this study: PubMed 35584010Joyce CT, Chernofsky A, Lodi S, Sherman KJ, Saper RB, Roseen EJ. Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain. J Orthop Sports Phys Ther. 2022 Jul;52(7):470-483. doi: 10.2519/jospt.2022.10813. Epub 2022 May 18.
- Derived from this study: PubMed 34698869Marshall A, Joyce CT, Tseng B, Gerlovin H, Yeh GY, Sherman KJ, Saper RB, Roseen EJ. Changes in Pain Self-Efficacy, Coping Skills, and Fear-Avoidance Beliefs in a Randomized Controlled Trial of Yoga, Physical Therapy, and Education for Chronic Low Back Pain. Pain Med. 2022 Apr 8;23(4):834-843. doi: 10.1093/pm/pnab318.
- Derived from this study: PubMed 33556352Joyce C, Roseen EJ, Keysor JJ, Gross KD, Culpepper L, Saper RB. Can Yoga or Physical Therapy for Chronic Low Back Pain Improve Depression and Anxiety Among Adults From a Racially Diverse, Low-Income Community? A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jun;102(6):1049-1058. doi: 10.1016/j.apmr.2021.01.072. Epub 2021 Feb 5.
- Derived from this study: PubMed 32662833Roseen EJ, Gerlovin H, Felson DT, Delitto A, Sherman KJ, Saper RB. Which Chronic Low Back Pain Patients Respond Favorably to Yoga, Physical Therapy, and a Self-care Book? Responder Analyses from a Randomized Controlled Trial. Pain Med. 2021 Feb 4;22(1):165-180. doi: 10.1093/pm/pnaa153.
- Derived from this study: PubMed 32500130Berlowitz J, Hall DL, Joyce C, Fredman L, Sherman KJ, Saper RB, Roseen EJ. Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial. Pain Med. 2020 Oct 1;21(10):2529-2537. doi: 10.1093/pm/pnaa150.
- Derived from this study: PubMed 31667747Roseen EJ, Gerlovin H, Femia A, Cho J, Bertisch S, Redline S, Sherman KJ, Saper R. Yoga, Physical Therapy, and Back Pain Education for Sleep Quality in Low-Income Racially Diverse Adults with Chronic Low Back Pain: a Secondary Analysis of a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):167-176. doi: 10.1007/s11606-019-05329-4. Epub 2019 Oct 30.
- Derived from this study: PubMed 28631003Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
- Derived from this study: PubMed 24568299Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
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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.
Robert B Saper, MD, MPH principal investigator
Boston University School of Medicine/ Boston Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly yoga classes, Individual physical therapy treatment and Education in people with Back Pain Lower Back Chronic, run by Boston Medical Center at 8 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 15 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 from Baseline in Average Pain intensity in previous week (time frame: 12 wks). 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?
On the ClinicalTrials.gov record for NCT01343927, which also lists 11 linked publications.
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 7 Feb 2019.