Low Back Pain
Conditions
Keywords
LPB, RCT, Intervention study, Cost effectiveness, Yoga, evidence based, advice to stay active, exercise training
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.
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.
Interventions
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
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days on Sick Leave | 12 MONTHS | Sick leave using self-reported data on number of days on sick leave |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | 6 months, 12 months | Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses. |
Countries
Sweden
Participant flow
Recruitment details
Recruitment details: period sept 2010-dec 2011, invited to examination at a University clinic. 1st questionnaire ÖMSPQ to screen for risk level, 2nd extensive questionnaire covering multi aspects of back pain,3rd examination by a back specialist, 4th blinded randomisation to allocate to group, 5th information on allocation and evidence based advice
Pre-assignment details
exclusion: n 12 due to: below 90 on OMSPQ, comorbidities affecting ability to physical activity, not skilled in Swedish language, sick leave exceeding 2 weeks, red flags
Participants by arm
| Arm | Count |
|---|---|
| Exercise Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet | 52 |
| Self Care Advice to Stay Active Evidence based advice from caregiver to stay active and exercise
Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet | 55 |
| Medical 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 | 52 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 15 | 4 |
Baseline characteristics
| Characteristic | Self Care Advice to Stay Active | Medical Yoga | Exercise | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 52 Participants | 52 Participants | 159 Participants |
| Age, Continuous | 43.9 years STANDARD_DEVIATION 11.7 | 46.9 years STANDARD_DEVIATION 9.6 | 46.3 years STANDARD_DEVIATION 9.3 | 45.7 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Sweden | 55 participants | 52 participants | 52 participants | 159 participants |
| Sex: Female, Male Female | 44 Participants | 37 Participants | 32 Participants | 113 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 20 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Number of Days on Sick Leave
Sick leave using self-reported data on number of days on sick leave
Time frame: 12 MONTHS
Population: by a power calculation based on estimates of change in the primary outcome variables from earlier studies
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise | Number of Days on Sick Leave | 9.5 Days | Standard Deviation 22.2 |
| Self Care Advice to Stay Active | Number of Days on Sick Leave | 9.2 Days | Standard Deviation 23.1 |
| Medical Yoga | Number of Days on Sick Leave | 3.6 Days | Standard Deviation 6.3 |
Cost Effectiveness
Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.
Time frame: 6 months, 12 months