Cost Effectiveness of Medical Yoga Therapy on Low Back Pain
MYTH
Cost Effectiveness of Early Interventions for Non-specific Low Back Pain: A Randomized Controlled Study Investigating Medical Yoga, Exercise Therapy and Evidence Based Advice
1 other identifier
interventional
159
1 country
3
Brief Summary
This randomized controlled study will evaluate the cost effectiveness of a yoga intervention compared to two evidence based programs; giving advice to stay active and guided exercise sessions. The first active program includes a six week standardized strength training program where the participants are personally instructed by a trained physiotherapist. The second active program is a six week standardized kundalini yoga program with group sessions twice a week lead by an experienced yoga instructor. Both programs consist of two exercise sessions per week and lasts for six weeks. After six weeks the participants are instructed to continue practicing their program twice a week on their own. The hypothesis are that a kundalini yoga program as an early intervention for Low Back Pain (LBP) is more cost effective than the two other interventions studied. Participants were recruited through the occupational health services and by advertisement in the local press. Study subjects eligible for inclusion were informed of the study either by health care personnel at the occupational health care centers or by a research assistant at the Karolinska Institutet. Subjects were informed that if they were eligible to participate in the study they would be given the opportunity to participate in one of three approaches for treatment of neck and back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Sep 2009
Longer than P75 for not_applicable low-back-pain
3 active sites
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 Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedResults Posted
Study results publicly available
March 14, 2016
CompletedMarch 14, 2016
February 1, 2016
2.8 years
June 28, 2012
September 25, 2013
February 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Days on Sick Leave
Sick leave using self-reported data on number of days on sick leave
12 MONTHS
Secondary Outcomes (1)
Cost Effectiveness
6 months, 12 months
Study Arms (3)
kUNDALINI YOGA
EXPERIMENTALGuided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet "The Back book"
Self care advice to stay active
ACTIVE COMPARATOREvidence based advice from caregiver to stay active and exercise
Exercise
ACTIVE COMPARATORGuided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet "The Back book"
Interventions
Guided training twice a week for six weeks. Self instructing cd for home practice
Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet "The Back book"
Strength training at a gym supervised by a physical therapist twice a week during 6 weeks. Self training instruction was provided. A written self care pamphlet "The Back book"
Eligibility Criteria
You may qualify if:
- non- specific low back pain,
- years old,
- \> 90 points on the OMPSQ screening questionnaire for yellow flags and sufficient understanding of the Swedish language
You may not qualify if:
- presence of so called Red flags,
- pregnancy,
- comorbidities affecting the ability to perform the interventions,
- presently on sick leave for \> 8 weeks,
- ongoing regular weekly yoga practice or strength training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Friskis och svettis
Stockholm, Sweden
Institute of medical yoga
Stockholm, Sweden
Karolinska instituet
Stockholm, Sweden
Related Publications (1)
Bramberg EB, Bergstrom G, Jensen I, Hagberg J, Kwak L. Effects of yoga, strength training and advice on back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Mar 29;18(1):132. doi: 10.1186/s12891-017-1497-1.
PMID: 28356091DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Problems in recruiting eligible subject and drop outs especially in the control group resulted in a small number of subjects analysed.
Results Point of Contact
- Title
- Dr. Irene Jensen
- Organization
- Karolinska Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Irene B Jensen, PhD
Karolinska Institutet
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 31, 2012
Study Start
September 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 14, 2016
Results First Posted
March 14, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share