Cost Effectiveness of Medical Yoga Therapy on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

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.
    

Intervention name(s): Kundalini yoga; Self care advice; Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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"
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: LPB; RCT; Intervention study; Cost effectiveness; Yoga; evidence based; advice to stay active; exercise training