Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care

This study has been completed.
Sponsor:
Collaborators:
Agencia Lain Entralgo
Public Health Service of Madrid
Information provided by:
Carlos III Health Institute
ClinicalTrials.gov Identifier:
NCT00624533
First received: February 19, 2008
Last updated: February 26, 2008
Last verified: February 2008
  Purpose

The purpose of this randomized controlled trial was to assess the effectiveness of GDS Treatment Method for patients with subacute or chronic non-specific low back pain in Primary Care of Spanish National Health Service.


Condition Intervention Phase
Low Back Pain
Behavioral: GDS Method (muscular chains physical therapy method)
Behavioral: Conventional Physical Therapy in Primary Health Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Physiotherapeutic Treatment of Non-Specific Low Back Pain in Primary Care Centers Through GDS Techniques for Articular and Muscular Chains

Resource links provided by NLM:


Further study details as provided by Carlos III Health Institute:

Primary Outcome Measures:
  • Intensity of pain (VAS) [ Time Frame: At baseline, immediately after intervention,at 3-months and 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region [ Time Frame: At baseline, immediately after intervention,at 3-months and 6-months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 2006
Study Completion Date: October 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)
Behavioral: Conventional Physical Therapy in Primary Health Care

Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.

Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks.

Experimental: B
Group B was treated with the GDS Method (muscular and articular chains physiotherapy method)
Behavioral: GDS Method (muscular chains physical therapy method)
Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.

Detailed Description:

Low back pain is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%. It is responsible for a major portion of work absenteeism and is actually among those conditions which generate the greatest expense due to health and labor costs.

The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs.

There is considerable variation in LBP related clinical practice and a considerable number of clinical guidelines have been developed for the management of subacute and chronic LBP patients.

Experience in Primary Care Centers of Madrid shows that physiotherapeutic intervention based on GDS Method for Articular and Muscular Chains is an efficient technique in the treatment of patients with diagnosis of non-specific low back pain compared with conventional physiotherapy treatment in Primary Care based on electrotherapy (TENS and microwave)

Currently, no randomized studies examining the effects of this method for patients with subacute or chronic non-specific low back pain have been published.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants were required to:

  • Be aged 18 years or older;
  • Have been diagnosed with simple mechanical LBP by their doctor and prescribed physiotherapy;
  • Have an impairment secondary to functional overload and/or poor postural habits (patients with certain occupations were excluded if these could act as confounding factors);
  • Not be receiving any other form of treatment;
  • Not be neurologically compromised; and
  • To be in a subacute or chronic stage of LBP exceeding 4 weeks.

Exclusion Criteria:

Subjects were excluded if they:

  • Showed clear symptoms of depression;
  • Refused to participate;
  • Did not sign the informed consent form;
  • Had any cognitive impairment that would prevent them from following instructions;
  • Were unable to understand Spanish sufficiently to adequately follow instructions;
  • Had the intention of moving from the area;
  • Had any form of contraindication to the physiotherapeutic techniques to be applied to both groups;
  • Had red flags, or warning signs, of serious illness such as cancer, infection, fracture or cauda equinal syndrome;
  • Had yellow flags, or risk factors, for a psychological disorder or had lumbar pain whose main cause was not mechanical.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00624533

Locations
Spain
Complutense University
Madrid, Spain/Madrid, Spain, 28040
Sponsors and Collaborators
Carlos III Health Institute
Agencia Lain Entralgo
Public Health Service of Madrid
Investigators
Principal Investigator: José L Chicharro, MD Complutense University of Madrid
  More Information

Additional Information:
Publications:
Responsible Party: Joaquín Arenas Barbero, Carlos III Health Institute. General Director for evaluation and research
ClinicalTrials.gov Identifier: NCT00624533     History of Changes
Other Study ID Numbers: PI051650, PI051650, LA2007PISINISCIII77
Study First Received: February 19, 2008
Last Updated: February 26, 2008
Health Authority: Spain: Ethics Committee

Keywords provided by Carlos III Health Institute:
Low back Pain
Physical Therapy Modalities
Exercise Movement Techniques
Primary Health Care

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014