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

February 26, 2008 updated by: Carlos III Health Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Spain/Madrid
      • Madrid, Spain/Madrid, Spain, 28040
        • Complutense University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of pain (VAS)
Time Frame: At baseline, immediately after intervention,at 3-months and 6-months
At baseline, immediately after intervention,at 3-months and 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, immediately after intervention,at 3-months and 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos III Health Institute

Collaborators

Public Health Service of Madrid
Agencia Lain Entralgo

Investigators

  • Principal Investigator: José L Chicharro, MD, Complutense University of Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2008

Last Update Submitted That Met QC Criteria

February 26, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI051650
  • LA2007PISINISCIII77

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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