Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan

Chronic Pain Clinical Trial

Official title:

Yoga for Chronic Low Back Pain: A Type 1 Hybrid Implementation-Effectiveness Pragmatic Randomized Control Trial in the Cleveland Clinic Employee Health Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319691
• Other study ID #: 22-132
• Status: Completed
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study uses clinical trial and implementation science methodology to specifically assess the effectiveness of yoga into the management of chronic low back pain (cLBP) within the Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid effectiveness-implementation design, which tests a clinical intervention while collecting data on implementation. Studying and implementing evidence-based, non-pharmacologic interventions is an important strategy for improving pain management and reducing opioid use disorder.

Description:

The investigators will use a single (investigators) blinded two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga Later group) who will receive usual care. After the 24 week study period, participants in the Yoga Later Group will be offered the yoga intervention in a non-study format as well as a free yoga mat and access to online yoga for LBP videos.

The screening and enrollment process will all occur remotely and involves the following: 1) A telephone or Information Technology approved, The Health Insurance Portability and Accountability Act (HIPAA-secure), virtual meeting platform where participants provide consent for completion of eligibility screening through a standardized questionnaire; 2) if eligible, provision of information about the study presented by study personnel with use of an Institutional Review Board approved information page for informed consent, answering all questions about the study, and assuring participant understanding through the "teach back" method.

Randomization occurs after administering the baseline survey. Investigators will use a computerized randomization procedure built into the study management system, RedCap, to randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be used.

The study interventions start within approximately one week of baseline data collection and randomization. Participants will be asked to complete questionnaire forms at baseline, weeks 6, 12 and 24. All participants throughout the entire 24-week study can continue to receive routine medical care including doctor visits and pain medication.

The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is structured and reproducible. The full instructor manual and participant manual are available online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed by the Cleveland Clinic lead yoga instructor.

Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The degree of difficulty of postures learned increases with each segment. For each segment, the participants gradually learn a sequence of 12-15 poses. The protocol provides variations and uses various aids (e.g., chair, strap) to accommodate a range of physical abilities. Participants are strongly encouraged to practice at home for 30 minutes daily on days which they do not attend yoga class. To facilitate home practice, participants will be given a free yoga mat, participant manual, and provided access to online videos prepared by the study instructors.

Ten percent of online yoga classes will be virtually observed and assessed by a study team member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase consisting of larger optional classes for maintenance will follow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 15, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 18-64 years old

• Current non-specific LBP persisting =12 weeks with average pain intensity =4 for the previous week on an 11-point numerical rating scale

• Ability to speak and understand English

Exclusion Criteria:

• Any severe psychiatric or medical comorbidity in the Principal Investigator's judgment that would make study participation unsafe or not feasible.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Behavioral:
• Yoga
The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase during which, yoga participants will receive a reproducible standardized weekly yoga intervention delivered virtually with additional resources for home practice, followed by a 12-week Follow-up Phase.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Robert Saper	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. — View Citation

Saper 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. — View Citation

Saper 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. — View Citation

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. — View Citation

Saper 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Medical Expenditures for low back pain	Total and back-related medical expenditures for all participants for the six month study period will be compared between the yoga (Arm 1) and wait-list (Arm 2) control groups.; Cost of implementing the intervention will be measured to demonstrate the feasibility of evaluating cost-effectiveness of yoga compared to usual care for cLBP from the perspective of the payer.	Baseline to Week 24
Other	Participant Satisfaction	Acceptability will be measured by participant satisfaction with treatment (5-point Likert scale, 1 = very dissatisfied to 5 = very satisfied) and answers to open-ended questions about the effect of yoga, facilitators and barriers.	Baseline to week 24
Other	Sleep Quality	Overall change in sleep quality from baseline to weeks 6, 12 and 24, measured by PROMIS Sleep disturbance Short Form 8a, item #1, range: 0-4, with higher scores reflecting better sleep quality. Raw score at each time point will used for analysis.	Baseline to week 24
Primary	Self-reported average pain intensity for the previous week	11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain	Baseline
Primary	Change of self-reported average pain intensity for the previous week	11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain	Week 12
Primary	Self-reported back-related function	Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function	Baseline
Primary	Change of self-reported back-related function	Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function	Week 12
Secondary	Change of self-reported average pain intensity for the previous week	11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain	Week 24
Secondary	Change of self-reported back-related function	Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function	Week 24
Secondary	Analgesic use	Self-reported pain medications usage; dosage reported in milligrams	Baseline
Secondary	Analgesic use	Change of self-reported pain medications usage; dosage reported in milligrams	Week 12
Secondary	Analgesic use	Change of self-reported pain medications usage; dosage reported in milligrams	Week 24
Secondary	Global improvement	Overall improvement by self-report (6-point Likert scale, 1 = very worse to 6 = very improved).	Weeks 12 and 24
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 4a	PROMIS Pain domain asks 4 questions. Each question is rated from 1 to 5. Values are summed to create a total raw score. Raw scores are minimum 4 to maximum 20 and translate to a T score with a minimum 41.6 to maximum 75.6. A higher score equates to a higher pain interference.	Weeks 12 and 24