Trial Outcomes & Findings for Cost Effectiveness of Medical Yoga Therapy on Low Back Pain (NCT NCT01653782)

NCT ID: NCT01653782

Last Updated: 2016-03-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 159 participants
• Primary outcome timeframe: 12 MONTHS
• Results posted on: 2016-03-14

Participant Flow

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

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"

Participant milestones

Measure	Exercise Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet	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	Medical Yoga Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
Overall Study STARTED	52	55	52
Overall Study COMPLETED	36	37	46
Overall Study NOT COMPLETED	16	18	6

Reasons for withdrawal

Measure	Exercise Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet	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	Medical Yoga Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
Overall Study Withdrawal by Subject	9	15	4
Overall Study Lost to Follow-up	7	3	2

Baseline Characteristics

Cost Effectiveness of Medical Yoga Therapy on Low Back Pain

Baseline characteristics by cohort

Measure	Exercise n=52 Participants Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet	Self Care Advice to Stay Active n=55 Participants 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	Medical Yoga n=52 Participants 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	Total n=159 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	55 Participants n=7 Participants	52 Participants n=5 Participants	159 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 9.3 • n=5 Participants	43.9 years STANDARD_DEVIATION 11.7 • n=7 Participants	46.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	45.7 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	44 Participants n=7 Participants	37 Participants n=5 Participants	113 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	46 Participants n=4 Participants
Region of Enrollment Sweden	52 participants n=5 Participants	55 participants n=7 Participants	52 participants n=5 Participants	159 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 MONTHS

Population: by a power calculation based on estimates of change in the primary outcome variables from earlier studies

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

Outcome measures

Measure	Exercise n=36 Participants Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet	Self Care Advice to Stay Active n=37 Participants 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	Medical Yoga n=46 Participants Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
Number of Days on Sick Leave	9.5 Days Standard Deviation 22.2	9.2 Days Standard Deviation 23.1	3.6 Days Standard Deviation 6.3

SECONDARY outcome

Timeframe: 6 months, 12 months

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

Outcome measures

Outcome data not reported

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self Care Advice to Stay Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medical Yoga

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Irene Jensen

Karolinska Institute

Phone: +46852483218

Email: irene.jensen@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place