Improvement in Pain, Function and Quality of Life With a Exercise Program vs Non-steroidal Anti-inflammatory Analgesics in Subacute Low Back Pain. (DLSEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Grupo Rehabilitacion en Salud.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by:
Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01374269
First received: June 14, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Back Pain Lower Back
Other: Exercise program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Grupo Rehabilitacion en Salud:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Oswestry Disability

  • Roland-Morris questionnaire [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Roland-Morris questionnaire

  • Quality of life [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Improvement in quality of life assessed by SF-36 questionnaire at baseline.

  • Missing Workdays [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Missing Workdays decrease

  • Relapses of lumbar pain [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Decrease in the number of relapses of lumbar pain

  • Treatments associated with low back pain at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Other treatments associated with low back pain at 6 months, while running the experiment.

  • Side effects [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
    Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects

  • Adverse reactions [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    In the NSAIDs group by the presence or absence of adverse reactions


Estimated Enrollment: 112
Study Start Date: June 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Excercise
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
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.
Other Names:
  • Therapeutic exercise
  • Physiotherapy
Active Comparator: NSAID
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.
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.
Other Names:
  • Therapeutic exercise
  • Physiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 equina 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 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
  • Allergy to NSAIDs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374269

Locations
Colombia
Clínica de Las Américas Recruiting
Medellin, Antioquia, Colombia
Contact: Luz H Lugo Agudelo, Professor    057 314 7914944    luzh.lugo@gmail.com   
Contact: Rocio Romero, Nurse    057 301 4283433    rehabilitacionsalud@siu.udea.edu.co   
Principal Investigator: Luz H Lugo Agudelo, Professor         
Ips Universitaria Recruiting
Medellin, Antioquia, Colombia
Contact: Jesús A Plata Contreras, Professor    057 313 6957549    rehabilitacionudea@gamail.com   
Contact: Rocio Romero, Nurse    057 301 4283433    rehabilitacionsalud@siu.udea.edu.co   
Sub-Investigator: Jesus A Plata Contreras, Professor         
Principal Investigator: Fabio A Salinas, Professor         
Sub-Investigator: Kelly Payares, Professor         
Sub-Investigator: Luisa F Mesa, Student         
Sponsors and Collaborators
Grupo Rehabilitacion en Salud
Universidad de Antioquia
Investigators
Study Director: Luz H Lugo, Professor Universidad de Antioquia
  More Information

No publications provided

Responsible Party: Fabio Salinas Durán, Grupo Rehabilitación en Salud Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01374269     History of Changes
Other Study ID Numbers: DLSejervsaine, DLSEjercicioyAINES
Study First Received: June 14, 2011
Last Updated: June 23, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Grupo Rehabilitacion en Salud:
NSAIDS
Exercise
Physiotherapy
Subacute Low Back Pain
Pain
Visual Analogue Scale
oswesrty
Roland Morris
SF-36
Quality of life

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014