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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| kUNDALINI YOGA | Experimental | 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" Receives: Behavioral: Kundalini yoga |
| Self care advice to stay active | Active comparator | Evidence based advice from caregiver to stay active and exercise Receives: Behavioral: Self care advice |
| Exercise | Active comparator | Guided 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.
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)
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.
- First posted31 Jul 2012 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Irene Jensen, Karolinska Institutet
- Investigators
- Irene B Jensen, PhD, Principal investigator, Karolinska Institutet
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01653782
- Acronym / sponsor ID
- MYTH / 6411023
- Conditions
- Low Back Pain
- Keywords
- LPB, RCT, Intervention study, Cost effectiveness, Yoga, evidence based, advice to stay active, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kUNDALINI YOGA | Experimental | Behavioral: Kundalini yogaGuided 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 comparator | Behavioral: Self care adviceEvidence based advice from caregiver to stay active and exercise |
| Exercise | Active comparator | Behavioral: ExerciseGuided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet "The Back book" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kundalini yogaGuided training twice a week for six weeks. Self instructing cd for home practice | Behavioural | kUNDALINI YOGA |
| Self care adviceEvidence based advice from caregiver about keeping active, exercise and a written self care pamphlet "The Back book" | Behavioural | Self care advice to stay active |
| ExerciseStrength 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" | Behavioural | Exercise |
Primary outcome
Number of Days on Sick Leave
Time frame: 12 MONTHS
Sick leave using self-reported data on number of days on sick leave
1 secondary outcome
Cost Effectiveness
Time frame: 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28356091Bramberg 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.
- web page for the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene B Jensen, PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
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.