Back to resultsYOga for Patients With Chronic BACK Pain and Poor PROgnosis (YOBACK-PRO)
Primary Purpose
Low Back Pain, Chronic Low-back Pain, Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, chronic low back pain, yoga, poor prognosis
Eligibility Criteria
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.
Sites / Locations
- IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas GeraisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Yoga
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Secondary Outcome Measures
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Pain intensity
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
Quality of life
EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)
Depressive symptoms
Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)
Pain self-efficacy
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Full Information
NCT ID
NCT05953155
First Posted
July 12, 2023
Last Updated
July 28, 2023
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT05953155
Brief Title
YOga for Patients With Chronic BACK Pain and Poor PROgnosis
Acronym
YOBACK-PRO
Official Title
Effectiveness of YOga in Patients With Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Low-back Pain, Back Pain, Back Pain Lower Back Chronic
Keywords
low back pain, chronic low back pain, yoga, poor prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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 Outcome Measure Information:
Title
Disability
Description
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Time Frame
Post-intervention (i.e. 3 months after randomisation)
Secondary Outcome Measure Information:
Title
Disability
Description
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Time Frame
6 months after randomisation
Title
Pain intensity
Description
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
Time Frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Title
Quality of life
Description
EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)
Time Frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Title
Depressive symptoms
Description
Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)
Time Frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Title
Pain self-efficacy
Description
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Time Frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Z Pinto, PhD
Phone
+55 31 3409 7405
Email
rafaelzp@ufmg.br
First Name & Middle Initial & Last Name or Official Title & Degree
Simone M Nunes, MSc
Phone
+55 31 32473137
Email
simacnunes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Z Pinto, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-110
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simne M Nunes, MSc
Phone
+55 31 32473137
Email
simacnunes@gmail.com
12. IPD Sharing Statement
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YOga for Patients With Chronic BACK Pain and Poor PROgnosis
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