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NCT Number: NCT05953155

YOga for Patients with Chronic BACK Pain and Poor PROgnosis

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).

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Key information

Conditions

Low Back Pain Back Pain Back Pain Lower Back Chronic Chronic Low-back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Belo Horizonte, Minas Gerais, 30130-110, Brazil

Location status: Recruiting

Location contact

Simne M Nunes, MSc

CONTACT

[email protected]

+55 31 32473137

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Control

Other

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.

yoga

Other

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.

Primary outcomes

  1. Disability

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

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

Secondary outcomes

  1. Disability

    Time frame: 6 months after randomisation

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

  2. Pain intensity

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

    Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)

  3. Quality of life

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

    EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)

  4. Depressive symptoms

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

    Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)

  5. Pain self-efficacy

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

    Pain Self-Efficacy Questionnaire (PSEQ) (0-60)

Study contacts

Contact information is provided by the study sponsor or research team.

Rafael Z Pinto, PhD

CONTACT

[email protected]

+55 31 3409 7405

Simone M Nunes, MSc

CONTACT

[email protected]

+55 31 32473137

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Effectiveness of YOga in Patients with Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial

Acronym: YOBACK-PRO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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