YOga for Patients With Chronic BACK Pain and Poor PROgnosis

Low Back Pain Clinical Trial

— YOBACK-PRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953155
• Other study ID #: CAAE: 57028022.0.0000.5149
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Federal University of Minas Gerais
• Contact: Rafael Z Pinto, PhD
• Phone: +55 31 3409 7405
• Email: rafaelzp[@]ufmg.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Control
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
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.

Locations

Country	Name	City	State
Brazil	IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)	Post-intervention (i.e. 3 months after randomisation)
Secondary	Disability	Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)	6 months after randomisation
Secondary	Pain intensity	Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)	Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Secondary	Quality of life	EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)	Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Secondary	Depressive symptoms	Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)	Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Secondary	Pain self-efficacy	Pain Self-Efficacy Questionnaire (PSEQ) (0-60)	Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up