NCT05953155

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is: \- In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone? A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
15mo left

Started Jul 2023

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

July 12, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

March 17, 2025

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

July 12, 2023

Last Update Submit

March 13, 2025

Conditions

Low Back PainChronic Low-back PainBack PainBack Pain Lower Back Chronic

Keywords

low back painchronic low back painyogapoor prognosis

Outcome Measures

Primary Outcomes (1)

  • Disability

    Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)

    Post-intervention (i.e. 3 months after randomisation)

Secondary Outcomes (5)

  • Disability

    6 months after randomisation

  • Pain intensity

    Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up

  • Quality of life

    Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up

  • Depressive symptoms

    Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up

  • Pain self-efficacy

    Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up

Study Arms (2)

Control

OTHER

The control group will be invited to attend 3 educational classes. In these sessions, participants will receive evidence-based information about self-management strategies and pain education.

Other: Control

Yoga

EXPERIMENTAL

In addition to the invitation to attend the same 3 educational classes on evidence-based information about self-management strategies and pain education, the experimental group will participate in a 12-week, twice-weekly group-based yoga program.

Other: Yoga

Interventions

ControlOTHER

Each educational class will last for 1 hour and consists of evidence-based information about low back pain, including, for example, self-management strategies, pain education, reassurance and common misconceptions about back pain.

Control
YogaOTHER

Participants in the intervention group will receive, in addition to the educational classes, a course of yoga program led by certified yoga instructors. The program consists of a 60-min group session with up to 10 participants, delivered twice a week for 12 weeks.

Yoga

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • report chronic nonspecific LBP, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration.
  • score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire.
  • have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale.

You may not qualify if:

  • serious spine pathology (e.g. tumors, fractures, and inflammatory diseases).
  • nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve).
  • previos spinal surgery.
  • pregnancy or having given birth within the previous 3 months.
  • any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases).
  • any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year.
  • not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise).
  • inadequate Portuguese literacy for the study's questionnaires and instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-110, Brazil

RECRUITING

Related Publications (1)

  • Nunes SM, Rizzo RR, Franco MR, Ferreira FR, Barros LJG, Maciel IT, Santos RL, Nascimento RR, Couto AJ, Quaresma LS, Fontes RM, Ferreira EMR, Maher CG, McAuley JH, Pinto RZ. Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial. BMJ Open. 2026 Jan 28;16(1):e112982. doi: 10.1136/bmjopen-2025-112982.

    PMID: 41605601DERIVED

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Rafael Z Pinto, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Z Pinto, PhD

CONTACT

+55 31 3409 7405rafaelzp@ufmg.br

Simone M Nunes, MSc

CONTACT

+55 31 32473137simacnunes@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 19, 2023

Study Start

July 27, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 30, 2027

Last Updated

March 17, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The data of this study will be available from the principal investigator upon reasonable request.

Locations

BR(1)