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Cost Effectiveness of Kundalini Yoga Therapy on Low Back Pain (RYS)

This study has been completed.
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Irene Jensen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01653782
First received: June 28, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Behavioral: Kundalini yoga
Behavioral: Self care advice
Behavioral: Exercise
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cost Effectiveness of Early Interventions for Non-specific Low Back Pain: A Randomized Controlled Study Investigating Yoga, Exercise Therapy and Evidence Based Advice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • work ability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Performance, sick leave, sickness presenteeism


Secondary Outcome Measures:
  • cost effectiveness [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.


Enrollment: 164
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: kUNDALINI YOGA
Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet "The Back book"
 Behavioral: Kundalini yoga
Guided training twice a week for six weeks. Self instructing cd for home practice
Active Comparator: Self care advice to stay active
Evidence based advice from caregiver to stay active and exercise
 Behavioral: Self care advice
Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet "The Back book"
Active Comparator: Exercise
Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet "The Back book"
 Behavioral: Exercise
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non- specific low back pain,
  • 18-60 years old,
  • > 90 points on the OMPSQ screening questionnaire for yellow flags and sufficient understanding of the Swedish language

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653782

Locations
Sweden
Institute of medical yoga
Stockholm, Sweden
Friskis och svettis
Stockholm, Sweden
Karolinska instituet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Council for Working Life and Social Research
  More Information

Additional Information:
web page for the study  This link exits the ClinicalTrials.gov site
web page for the research group  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Irene Jensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01653782     History of Changes
Other Study ID Numbers: 6411023
Study First Received: June 28, 2012
Last Updated: July 30, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
LPB
RCT
Intervention study
Cost effectiveness
 Yoga
evidence based
advice to stay active
exercise training

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013