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Low Back PainMYTHNCT01653782

Cost Effectiveness of Medical Yoga Therapy on Low Back Pain

A study testing Kundalini yoga, Self care advice and Exercise in people with Low Back Pain, run by Karolinska Institutet at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Low Back Pain
What is being tested?
Kundalini yoga, Self care advice and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
3 sitesSweden
Study dates
Sep 2009to Jun 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites
  • Friskis och svettis

    Stockholm

  • Institute of medical yoga

    Stockholm

  • Karolinska instituet

    Stockholm

Other trials in Sweden

About this study

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

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Kundalini yoga, Self care advice, Exercise
Keywords
LPB, RCT, Intervention study, Cost effectiveness, Yoga, evidence based, advice to stay active, exercise training
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kundalini yogaBehavioural

    Guided training twice a week for six weeks. Self instructing cd for home practice

  • Self care adviceBehavioural

    Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet "The Back book"

  • ExerciseBehavioural

    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"

Study groups in NCT01653782
Study groupRoleWhat they receive
kUNDALINI YOGAExperimentalGuided 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"
Receives: Behavioral: Kundalini yoga
Self care advice to stay activeActive comparatorEvidence based advice from caregiver to stay active and exercise
Receives: Behavioral: Self care advice
ExerciseActive comparatorGuided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet "The Back book"
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Days on Sick Leave

    Sick leave using self-reported data on number of days on sick leave

    Measured: 12 MONTHS

Secondary outcomes (1)
  1. Cost Effectiveness

    Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.

    Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01653782
Sponsor's protocol ID
6411023
Acronym
MYTH
Status last verified
Feb 2016
First submitted
28 Jun 2012
Last updated
14 Mar 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28356091

Questions about this trial

What is this clinical trial studying?

A study testing Kundalini yoga, Self care advice and Exercise in people with Low Back Pain, run by Karolinska Institutet at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days on Sick Leave (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01653782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.

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