Trial on Subacute Low Back Pain
Justina
A Randomized Controlled Clinical Trial of Stay-Active Care and Manual Therapy Versus Stay-Active Care Only in Subacute Low Back Pain in a Primary Health Care Setting. The Gotland Low Back Pain Study
1 other identifier
interventional
160
1 country
1
Brief Summary
A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. 160 outpatients with acute or subacute low back pain with or without pain radiation into the legs (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and randomly allocated to stay-active care with or without muscle stretching, or to manual therapy with or without specific corticosteroid injections in addition to the stay-active concept. Pain, disability rating index, and sickness absence measures were used as outcome at 10-week follow-up and sickness absence was measured at two-year follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1994
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedJune 18, 2009
June 1, 2009
4.9 years
June 17, 2009
June 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sick leave
2 years
Secondary Outcomes (2)
Disability
10 weeks
Pain
10 weeks
Study Arms (4)
S-A
ACTIVE COMPARATORS-A+stretch
ACTIVE COMPARATORS-A+stretch+manther
EXPERIMENTALS-A+stretch+manther+sterinject
EXPERIMENTALInterventions
Stay-active care and muscle stretching at home and during physiotherapist appointments
Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises
Manual therapy including steroid injection when indicated in addition to stay-active care and stretching during GP appointments (injections) and during GP or physiotherapist appointments (remaining treatment modalities)
Eligibility Criteria
You may qualify if:
- acute or subacute perceived low back pain with or without pain radiating to one or both legs
- symptom duration of three months or less preceded by at least two months of relative freedom from symptoms
- consent to treatment and follow up for ten weeks
- agreement not to consult therapists other than those participating in the study during the treatment period
You may not qualify if:
- other conditions or circumstances that might jeopardize completion of treatment and follow up, such as pregnancy, malignant tumors, etcetera
- need for acute surgical or rheumatologic care
- previous treatment of current complaints with specific mobilisation or manipulation
- previous participation in the present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Region Stockholmcollaborator
- National Social Insurance Board, Swedencollaborator
- Uppsala County Council, Swedencollaborator
- Länsförsäkringar Research Foundationcollaborator
Study Sites (1)
Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section
Uppsala, SE-75185, Sweden
Related Publications (5)
Grunnesjo MI, Bogefeldt JP, Svardsudd KF, Blomberg SI. A randomized controlled clinical trial of stay-active care versus manual therapy in addition to stay-active care: functional variables and pain. J Manipulative Physiol Ther. 2004 Sep;27(7):431-41. doi: 10.1016/j.jmpt.2004.06.001.
PMID: 15389174RESULTGrunnesjo M, Bogefeldt J, Blomberg S, Delaney H, Svardsudd K. The course of pain drawings during a 10-week treatment period in patients with acute and sub-acute low back pain. BMC Musculoskelet Disord. 2006 Aug 11;7:65. doi: 10.1186/1471-2474-7-65.
PMID: 16901354RESULTBogefeldt J, Grunnesjo M, Svardsudd K, Blomberg S. Diagnostic differences between general practitioners and orthopaedic surgeons in low back pain patients. Ups J Med Sci. 2007;112(2):199-212. doi: 10.3109/2000-1967-194.
PMID: 17578820RESULTBogefeldt J, Grunnesjo MI, Svardsudd K, Blomberg S. Sick leave reductions from a comprehensive manual therapy programme for low back pain: the Gotland Low Back Pain Study. Clin Rehabil. 2008 Jun;22(6):529-41. doi: 10.1177/0269215507087294.
PMID: 18511533RESULTGrunnesjo MI, Bogefeldt JP, Blomberg SI, Strender LE, Svardsudd KF. A randomized controlled trial of the effects of muscle stretching, manual therapy and steroid injections in addition to 'stay active' care on health-related quality of life in acute or subacute low back pain. Clin Rehabil. 2011 Nov;25(11):999-1010. doi: 10.1177/0269215511403512. Epub 2011 Aug 10.
PMID: 21831926DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 18, 2009
Study Start
January 1, 1994
Primary Completion
December 1, 1998
Study Completion
December 1, 2000
Last Updated
June 18, 2009
Record last verified: 2009-06