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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      General 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.

      Specific Objectives

        1. To evaluate the efficacy of a protocolized exercise program in reducing low back pain.

        2. To evaluate the efficacy of a protocolized exercise program in improving the function.

        3. To compare the effects of both interventions on quality of life and work absenteeism in
           the two groups of patients.

        4. To compare the safety of both interventions.

        5. To estimate adherence and causes of non-adherence of patients to different treatments
           proposed.

        6. To compare in both groups the number of relapses, general and specialized medical
           consultations, screening studies, images and other treatments associated with low back
           pain.

           Null Hypothesis Management of subacute low back pain patients with a protocolized
           exercise program is not more effective than treatment with NSAIDs to reduce pain at
           least in 25 mm, measured with a Visual Analog Scale 0-100 mm.

           Alternative hypothesis Management of subacute low back pain patients with a protocolized
           exercise program is not more effective than treatment with NSAIDs to reduce pain at
           least in 25 mm, measured with a Visual Analog Scale 0-100 mm.

           Methodology:

           Type of study: randomized controlled clinical trial, single-blinded with independent
           evaluators.

           Reference population: Patients consulting physiatrists in different physical medicine
           and rehabilitation departments in Medellin, Colombia.

           Study population: patients with subacute low back pain -evolution time more than 6 weeks
           and less than 3 months-, with or without radiculopathy, and that fulfill inclusion
           criteria. In addition patients must sign an informed consent to participate in research.

           Inclusion criteria:

             -  Patients aged between 18 and 60 years with subacute low back pain.

             -  Evolution time more than 6 weeks and less than 3 months.

             -  That were included in the social security system and live in the metropolitan area.

           Exclusion criteria:

             -  Antecedents of spinal, pelvis or abdominal trauma.

             -  Cancer.

             -  Diabetes mellitus.

             -  Steroid use.

             -  Women over 60 years.

             -  Cauda equine syndrome.

             -  Men with osteoporosis or compression fractures.

             -  Suspicion of infection

             -  Insidious onset

             -  Constitutional symptoms

             -  Intravenous drugs abuse

             -  HIV

             -  Immunosuppression

             -  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.

           Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0
           to 100, assessed 4 weeks after intervention.

           Secondary outcomes:

           Improvement in function assessed by the Oswestry Disability Index and Roland-Morris
           questionnaire comparing baseline to first, three and six months follow-up.

           Improvement in quality of life assessed by SF-36 (The Short Form Health Survey)
           questionnaire at baseline and at first, third and sixth months.

           Work absenteeism decrease. Decrease in the number of relapses, general and specialized
           medical consultations, screening studies, images and other treatments associated with
           low back pain at 6 months.

           Safety of both treatments evaluated in the exercise group by tolerance to training and
           presence or not of side effects, and in the NSAIDs group by the presence or absence of
           adverse reactions.

           Sample:

           Sampling type: simple random. Sample size calculation was based on software "Sample size
           Javeriana University" Type I error: 0.05 Type II Error: 0.2 Assessments number prior to
           randomization: 1 Assessments number after randomization: 3 Correlation between
           evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33
           Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73

           Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6,
           generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA).
           Allocation will be confidential and will not be opened until the investigation is
           completed, this will be monitored by the Committee of Data Security.

           Enrollment Patients with subacute low back pain consulting Physical Medicine and
           Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial
           assessment, and if patient is considered eligible will be invited to participate and
           asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an
           opaque envelope.

           Masking Medical researchers who evaluate the patients, research assistants who perform
           the application of different measure instruments and statistical will be blinded to
           treatment allocation.

           Initial assessment Clinical evaluation will be performed by one of the research
           physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale
           (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale.

           Intervention One group will be assigned to protocolized back pain exercise, three times
           a week for 4 weeks. This program is carried out by physiotherapists from participating
           institutions who wish to participate in research and who will be given a training which
           will standardize the intervention programs Exercise program includes: physical agents,
           massage of myofascial points, stretching and strengthening exercises, cycloergometer or
           band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse
           reactions will be registered. The second group will receive NSAID for 10 days, there
           will be two different options (naproxen or celecoxib) according to indications and
           contraindications. In case of increase in pain intensity in either of the two groups,
           acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue.

           Adherence to different treatments. To ensure adherence to different treatments each
           patient will receive a phone call weekly to inquire about assistance, difficulties,
           tolerance, use of medications, and adverse effects. Patients will be given a
           questionnaire to verify drugs intake, dosage, time and side effects. They should also
           register any other drug ingestion.

           Telephone calls will be made every 15 days to ask about the health status and ensuring
           assistance to new assessments.

           Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed
           by one of the researcher physiatrists or a postgraduate student.

           Committee of safety and quality of data. This committee will consist of two researchers
           and one professional information management responsible for the database. This will be
           done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting
           information recollection.

           Analysis Plan Categorical univariate variables will be analyzed by frequency
           distributions and quantitative variables by measures of central tendency (mean, standard
           deviation, median or range). Both groups will be compared after randomization and before
           intervention for all variables.

           Initially, it will be established for each group if the quantitative variables are of
           normal distribution, by using the Kolmogorov-Smirnov test.

           Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will
           be compared with initial pain (mean and confidence intervals) by using Student t test or
           Mann Whitney for each time period. The same procedure would be for the other outcomes
           measured quantitatively.

           An analysis of variance with repeated measures for the variability between groups and
           intragroup will be made.

           Comparison of categorical variables at each assessment will be done using the Chi2 test.

           The level of statistical significance to be used in all cases is 0.05. An analysis by
           intention to treat and per protocol will be made.

           Ethics This research and informed consent is according to "Scientific, technical and
           administrative standards for health research" of the Ministry of Health and the Decree
           309 of 2000 of the Ministry of Environment. This is considered a minimal risk research,
           because therapeutic interventions are widely used to treat patients with these
           conditions.
    

Intervention name(s): Exercise program; NSAID (Nonsteroidal anti-inflammatory drugs)
Intervention type(s): Other; Drug
Intervention description(s): 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.
Other intervention name(s): Therapeutic exercise; Physiotherapy; Naproxen; Celecoxib; Acetaminophen
Intervention MeSH terms: Acetaminophen; Celecoxib; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSAIDS (Nonsteroidal anti-inflammatory drugs); Exercise; Physiotherapy; Subacute Low Back Pain; Pain; Visual Analogue Scale; oswesrty; Roland Morris; SF-36; Quality of life