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Completed

NCT Number: NCT00624533

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Complutense University

Madrid, Spain/Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GDS Method (muscular chains physical therapy method)

Behavioral

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.

Conventional Physical Therapy in Primary Health Care

Behavioral

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.

Primary outcomes

  1. Intensity of pain (VAS)

    Time frame: At baseline, immediately after intervention,at 3-months and 6-months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Carlos III Health Institute

Other Gov

Collaborators

  • Agencia Lain Entralgo
  • Public Health Service of Madrid

Registry information

Official study 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

Acronym: GDS

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 27, 2008
Registry last updated
Feb 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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