Trial on Subacute Low Back Pain
Condition: Subacute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Stay-active care; Stay-active care+stretching; Stay-active+stretching+manual therapy; Stay-active+stretching+manual therapy+steroid injections
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): No other treatment than the stay-active care; 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual therapy; Low back pain; Pain; Return to work