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

NCT05319691 | Completed

• 1 other identifier: 22-132
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Back Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Self-reported back-related function

  Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function

  Baseline

• 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 Outcomes (7)

• Change of self-reported average pain intensity for the previous week

  Week 24

• Change of self-reported back-related function

  Week 24

• Analgesic use

  Baseline

• Analgesic use

  Week 12

• Analgesic use

  Week 24

Other Outcomes (3)

• Total Medical Expenditures for low back pain

  Baseline to Week 24

• Participant Satisfaction

  Baseline to week 24

• Sleep Quality

  Baseline to week 24

Study Arms (2)

Yoga Now (Treatment Group)

ACTIVE COMPARATOR

An initial 12-week Treatment Phase of weekly virtual yoga classes (Yoga Now) followed by a 12-week Follow-up Phase.

Behavioral: Yoga

Yoga Later (Wait List Control Group)

NO INTERVENTION

A wait-list control group (Yoga Later) will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.

Interventions

Yoga BEHAVIORAL

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.

Also known as: Treatment Group, Yoga Now

Yoga Now (Treatment Group)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Robert Saper: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• 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.

  PMID: 22310560 BACKGROUND

• 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.

  PMID: 24568299 BACKGROUND

• 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.

  PMID: 19943573 BACKGROUND

• 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.

  PMID: 23878604 BACKGROUND

• 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.

  PMID: 28631003 BACKGROUND

• Tankha H, Gaskins D, Shallcross A, Rothberg M, Hu B, Guo N, Roseen EJ, Dombrowski S, Bar J, Warren R, Wilgus H, Tate P, Goldfarb J, Drago VG, Saper R. Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442339. doi: 10.1001/jamanetworkopen.2024.42339.

  PMID: 39485352 DERIVED

MeSH Terms

Conditions

Chronic Pain; Back Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Robert B Saper, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will use a single-blinded (investigator) two-arm randomized control trial (RCT) design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigators will use a single-blinded (investigator) 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) or a wait-list control (Yoga Later) who will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: April 8, 2022
• Study Start: May 3, 2022
• Primary Completion: May 30, 2023
• Study Completion: August 15, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)