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Cost Effectiveness of Medical Yoga Therapy on Low Back Pain (MYTH)

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ClinicalTrials.gov Identifier: NCT01653782
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Low Back Pain Behavioral: Kundalini yoga Behavioral: Self care advice Behavioral: Exercise

Detailed Description:

The study was a randomized control trial with a 12-month follow-up that compared active early intervention using medical yoga with exercise therapy and self-care advice. The medical yoga intervention was a standardized program based on Kundalini yoga. The group was led by an experienced yoga instructor. The exercise therapy was a standardized strength training program led by a trained physiotherapist. Both medical yoga and exercise interventions were held in groups and included two sessions per week over six weeks. After the sixth week, participants were instructed to continue practicing at least twice a week on their own. In the medical yoga group, the participants received written information and a disk providing additional guidance. In the exercise therapy group, the participants received tailored written information on exercise. The third group, evidence-based self-care advice, was physically examined by experienced back pain experts (an orthopedic specialist and a licensed chiropractor), and received an oral recommendation to stay active and a booklet containing evidenced-based self-care advice.

The participants were randomized to one of these three treatment groups after undergoing the initial examination and receiving the evidence-based information on self-care and staying active. The form of randomization was block randomization using the pre-randomization technique, in which for each participant an opaque envelope was picked, in consecutive order, by an external research assistant who had no contact with the participants. After randomization the back pain specialist met with the participants and gave them background information about the intervention they were being offered. Previous studies [19, 20] have shown that expectations of treatment and response levels differ depending on, whether the treatment is physically or psychologically oriented. Therefore, the two training interventions (yoga and exercise therapies) were both presented as well established training therapies, to improve the level of participation and to equalize the participants' expectations of the treatment and its outcomes. After the assignment of study participants to intervention groups, the statistician who performed the analyses on the intervention outcomes was "blinded". This implies that the statistician while assessing the outcomes of the interventions was not aware of the assigned intervention of participants and therefore, was not influenced in any way by the knowledge of which group was the intervention or the control.

Ethical consideration All three groups received treatments based on ethical grounds. The study was approved by the Regional Ethics Committee (2010/108-31/3) and registered in the clinicaltrials.gov protocol registration system (NCT01653782).

Data collection Participants were recruited through the Occupational Health Services (OHS) and by advertisement in the local media in Sweden's Stockholm County. People of working age with neck/back pain were invited to apply for participation in the study. Then, a screening questionnaire was mailed to those who responded to the invitation to participate in the study. Those who scored 90 points or more, i.e., fulfilling the requirements for a yellow flag, on the Örebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) [25] were invited for further physical examination.

The inclusion criteria were having non-specific low back pain, being with the age range of 18-60, having scored 90 points or more on the OMPSQ screening questionnaire and having a sufficient command of Swedish. The exclusion criteria were pregnancy, comorbidities that could affect the ability to perform exercise, ongoing regular weekly yoga practice or strength training and ongoing sickness absences of eight weeks or more.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cost Effectiveness of Early Interventions for Non-specific Low Back Pain: A Randomized Controlled Study Investigating Medical Yoga, Exercise Therapy and Evidence Based Advice
Study Start Date : September 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: kUNDALINI YOGA
Guided 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"
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"


Outcome Measures

Primary Outcome Measures :
  1. Number of Days on Sick Leave [ Time Frame: 12 MONTHS ]
    Sick leave using self-reported data on number of days on sick leave


Secondary Outcome Measures :
  1. Cost Effectiveness [ Time Frame: 6 months, 12 months ]
    Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653782


Locations
Sweden
Friskis och svettis
Stockholm, Sweden
Institute of medical yoga
Stockholm, Sweden
Karolinska instituet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Council for Working Life and Social Research
Investigators
Principal Investigator: Irene B Jensen, PhD Karolinska Institutet
More Information

Additional Information:
Responsible Party: Irene Jensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01653782     History of Changes
Other Study ID Numbers: 6411023
First Posted: July 31, 2012    Key Record Dates
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Irene Jensen, 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