Trial on Subacute Low Back Pain (Justina)
Primary Purpose
Subacute Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Stay-active care
Stay-active care+stretching
Stay-active+stretching+manual therapy
Stay-active+stretching+manual therapy+steroid injections
Sponsored by
About this trial
This is an interventional treatment trial for Subacute Low Back Pain focused on measuring Manual therapy, Low back pain, Pain, Return to work
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
S-A
S-A+stretch
S-A+stretch+manther
S-A+stretch+manther+sterinject
Arm Description
Outcomes
Primary Outcome Measures
Sick leave
Secondary Outcome Measures
Disability
Pain
Full Information
NCT ID
NCT00923429
First Posted
June 17, 2009
Last Updated
June 17, 2009
Sponsor
Uppsala University
Collaborators
Region Stockholm, National Social Insurance Board, Sweden, Uppsala County Council, Sweden, Länsförsäkringar Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00923429
Brief Title
Trial on Subacute Low Back Pain
Acronym
Justina
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 1994 (undefined)
Primary Completion Date
December 1998 (Actual)
Study Completion Date
December 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Region Stockholm, National Social Insurance Board, Sweden, Uppsala County Council, Sweden, Länsförsäkringar Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study is a randomized, controlled, clinical trial in the Swedish province of Gotland, with primary data collection from 1994 to 1998. The recruitment population consisted of the 19000 employed persons born in Sweden, 20-55 years of age. Additional inclusion criteria were:
Acute or subacute perceived low back pain with or without pain radiating to one or both legs, not requiring acute surgical or rheumatological care, low back pain was required to be the dominating symptom, symptom duration of 3 months or less, preceded by at least 2 months of relative freedom from symptoms, consent to treatment and follow-up for 10 weeks, agreement not to consult other therapists during the treatment period, absence of conditions or circumstances that might jeopardize completion of treatment and follow-up, no previous treatment of current complaints with specific mobilization or manipulation, and no previous participation in the present study.
In Sweden, the National Social Insurance Offices (a government agency running the mandatory national social insurance scheme applicable to all Swedish residents) handle sick leave with a duration of two weeks or more. They as well as general practitioners (GP) and other physicians referred patients. The recruiting physician examined all patients, performed a physical examination, and made the final assessment whether they fulfilled the inclusion criteria. Of the 316 patients who were referred to the study, 111 did not meet the inclusion criteria and 45 declined participation. The 160 patients that gave informed consent were entered in the study. After baseline evaluation they were randomized by the study monitor, using sealed pre-prepared envelopes with group assignment derived from a random number table. The envelopes were inaccessible to anyone but the monitor. A design with four treatment groups was used: two experimental and two reference groups with treatment items added successively. The two-group comparison (reference vs experimental treatment) was the primary planned analysis, and pain, disability rating and sickness absence were the main outcome measures. A weighted randomization procedure was used, with 45% of the patients to reference and 55% to the experimental therapies. The Research Ethics Committee at Uppsala University approved the study.
The stay active concept was the basic management strategy in all study groups. Treatment was individual, in groups or both. Treatment modalities were chosen from a group-specific 'toolbox' after clinical assessment of the patients and according to need. Two orthopedic surgeons at Visby Hospital and eight physiotherapists treated the reference patients. In accordance with the study design, muscle stretching was a treatment option in 51% of the reference group, 41% actually received muscle stretching. Two GPs and nine physiotherapists treated the experimental patients. They received the full reference treatment, plus specific mobilization, spinal manipulation, and auto-traction when indicated. Steroid injections were a treatment option in 52% of the experimental group, 36% actually received injections.
The study population was followed over ten weeks with measurements of outcome and progression variables. Outcome measures were self-reported back pain, disability rating, return to work as assessed from sick leave records, quality of life measures, and pain drawings. Moreover, sick leave data during two years of follow up from baseline were obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Low Back Pain
Keywords
Manual therapy, Low back pain, Pain, Return to work
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-A
Arm Type
Active Comparator
Arm Title
S-A+stretch
Arm Type
Active Comparator
Arm Title
S-A+stretch+manther
Arm Type
Experimental
Arm Title
S-A+stretch+manther+sterinject
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Stay-active care
Intervention Description
No other treatment than the stay-active care
Intervention Type
Procedure
Intervention Name(s)
Stay-active care+stretching
Intervention Description
Stay-active care and muscle stretching at home and during physiotherapist appointments
Intervention Type
Procedure
Intervention Name(s)
Stay-active+stretching+manual therapy
Intervention Description
Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises
Intervention Type
Procedure
Intervention Name(s)
Stay-active+stretching+manual therapy+steroid injections
Intervention Description
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)
Primary Outcome Measure Information:
Title
Sick leave
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disability
Time Frame
10 weeks
Title
Pain
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15389174
Citation
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.
Results Reference
result
PubMed Identifier
16901354
Citation
Grunnesjo 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.
Results Reference
result
PubMed Identifier
17578820
Citation
Bogefeldt 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.
Results Reference
result
PubMed Identifier
18511533
Citation
Bogefeldt 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.
Results Reference
result
PubMed Identifier
21831926
Citation
Grunnesjo 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.
Results Reference
derived
Links:
URL
http://www.pubcare.uu.se
Description
Department of Public Health and Caring Sciences
Learn more about this trial
Trial on Subacute Low Back Pain
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