Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory)
Condition: Back Pain Lower Back
MeSH terms: Back Pain; Low Back Pain
Intervention: Exercise program; NSAID (Nonsteroidal anti-inflammatory drugs)
Intervention description: Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.; The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
Intervention MeSH terms: Acetaminophen; Celecoxib; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: NSAIDS (Nonsteroidal anti-inflammatory drugs); Exercise; Physiotherapy; Subacute Low Back Pain; Pain; Visual Analogue Scale; oswesrty; Roland Morris; SF-36; Quality of life

Summary:

      Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and
      improving function and quality of life during a 6-months follow-up of a therapeutic exercise
      program compared to pharmacological treatment with NSAIDs in patients with subacute low back
      pain attending the physiatrist consultation of several ambulatory health centers in Medellín
      during the years 2009-2010.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 18 and 60 years old

          -  Subacute low back pain -evolution time more than 4 weeks and less than 3 months.

          -  That have social security system

          -  Live in the metropolitan area

        Exclusion Criteria:

          -  Antecedents of spinal, pelvis or abdominal trauma

          -  Cancer

          -  Diabetes mellitus

          -  Steroids use

          -  Men and Women over 60 years

          -  Cauda equine syndrome

          -  Women and men with osteoporosis or compression fractures

          -  Suspicion of infection.

          -  Insidious onset, constitutional symptoms

          -  Intravenous drugs abuse

          -  HIV

          -  Immunosuppression or previous surgery

          -  Rheumatic diseases

          -  Urinary tract infections

          -  Neurological symptoms in lower limbs

          -  Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)

          -  Deformities in the spine (scoliosis greater than 15º)

          -  History of peptic acid disease

          -  Renal failure

          -  Intake of anticoagulants or antiplatelet drugs

          -  Allergy to NSAIDs.