Trial on Subacute Low Back Pain (Justina)

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
National Social Insurance Board, Sweden
Uppsala County Council, Sweden
Länsförsäkringar Research Foundation
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00923429
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Subacute Low Back Pain
Procedure: Stay-active care
Procedure: Stay-active care+stretching
Procedure: Stay-active+stretching+manual therapy
Procedure: Stay-active+stretching+manual therapy+steroid injections

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Sick leave [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 1994
Study Completion Date: December 2000
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-A Procedure: Stay-active care
No other treatment than the stay-active care
Active Comparator: S-A+stretch Procedure: Stay-active care+stretching
Stay-active care and muscle stretching at home and during physiotherapist appointments
Experimental: S-A+stretch+manther Procedure: Stay-active+stretching+manual therapy
Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises
Experimental: S-A+stretch+manther+sterinject Procedure: Stay-active+stretching+manual therapy+steroid injections
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923429

Locations
Sweden
Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University
Stockholm County Council, Sweden
National Social Insurance Board, Sweden
Uppsala County Council, Sweden
Länsförsäkringar Research Foundation
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt Svärdsudd, professor, section head, Uppsala University
ClinicalTrials.gov Identifier: NCT00923429     History of Changes
Other Study ID Numbers: Justina
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: Sweden: Swedish Research Council

Keywords provided by Uppsala University:
Manual therapy
Low back pain
Pain
Return to work

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014