Improvement in Pain, Function and Quality of Life With a Exercise Program vs Non-steroidal Anti-inflammatory Analgesics in Subacute Low Back Pain. (DLSEA)
Recruitment status was Recruiting
|First Received Date ICMJE||June 14, 2011|
|Last Updated Date||June 23, 2011|
|Start Date ICMJE||June 2009|
|Estimated Primary Completion Date||October 2011 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Visual Analogue Scale of Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01374269 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Improvement in Pain, Function and Quality of Life With a Exercise Program vs Non-steroidal Anti-inflammatory Analgesics in Subacute Low Back Pain.|
|Official Title ICMJE||Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010|
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.
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.
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.
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 or steroid use, women over 60 years, cauda equina syndrome, 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 somatomorph disorder, major depression), deformities in the spine (scoliosis greater than 15º), history of peptic acid disease, renal failure, intake of anticoagulants or antiplatelet drugs, and 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 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.
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 SPSS15 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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Back Pain Lower Back|
|Intervention ICMJE||Other: Exercise program
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.
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||112|
|Estimated Completion Date||March 2012|
|Estimated Primary Completion Date||October 2011 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 60 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||Colombia|
|NCT Number ICMJE||NCT01374269|
|Other Study ID Numbers ICMJE||DLSejervsaine, DLSEjercicioyAINES|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Fabio Salinas Durán, Grupo Rehabilitación en Salud Universidad de Antioquia|
|Study Sponsor ICMJE||Grupo Rehabilitacion en Salud|
|Collaborators ICMJE||Universidad de Antioquia|
|Information Provided By||Grupo Rehabilitacion en Salud|
|Verification Date||June 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP