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)

NCT01374269 | Completed Phase 4 Results DMC

• 2 other identifiers: DLSejervsaineDLSEjercicioyAINES
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Back Pain Lower Back

Keywords

NSAIDS (Nonsteroidal anti-inflammatory drugs); Exercise; Physiotherapy; Subacute Low Back Pain; Pain; Visual Analogue Scale; oswesrty; Roland Morris; SF-36; Quality of life

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale of Pain

  In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at the beginning.

  At the beginning

• Visual Analogue Scale of Pain

  In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at 4 weeks.

  4 weeks

• Visual Analogue Scale of Pain

  In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at 12 weeks.

  12 weeks

• Visual Analogue Scale of Pain

  The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.

  24 weeks

Secondary Outcomes (58)

• Oswestry Disability Index

  At the beginning

• Oswestry Disability Index

  4 weeks

• Oswestry Disability Index

  12 weeks

• Oswestry Disability Index

  24 weeks

• Roland-Morris Questionnaire

  At the beginning

Study Arms (2)

Excercise

EXPERIMENTAL

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

NSAID

ACTIVE COMPARATOR

Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

Drug: NSAID (Nonsteroidal anti-inflammatory drugs)

Interventions

Exercise program OTHER

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.

Also known as: Therapeutic exercise, Physiotherapy

Excercise

NSAID (Nonsteroidal anti-inflammatory drugs) DRUG

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.

Also known as: Naproxen, Celecoxib, Acetaminophen

NSAID

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Rehabilitacion en Salud: lead
• Universidad de Antioquia: collaborator

Study Sites (2)

Clínica de Las Américas

Medellín, Antioquia, Colombia

Location

Ips Universitaria

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Pain

Interventions

Resistance Training; Exercise Therapy; Physical Therapy Modalities; Anti-Inflammatory Agents, Non-Steroidal; Naproxen; Celecoxib; Acetaminophen

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Limitations and Caveats

The study population was associated with the university's health service. Female subjects predominated. The 6-month follow-up prevents conclusions about the improvement duration. No subgroup classification was performed. No control group was planned.

Results Point of Contact

• Title: Dr. Fabio Salinas Duran
• Organization: Grupo Rehabilitacion en Salud

fabios@une.net.co

5742196475

Study Officials

• Luz H Lugo, Professor

  Universidad de Antioquia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 15, 2011
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 29, 2014
• Results First Posted: April 29, 2014

Record last verified: 2014-03

Locations

CO (2)