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

NCT ID: NCT00624533

Last Updated: 2008-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-10-31

Brief Summary

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.

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.

Conditions

Low Back Pain

Keywords

Low back Pain; Physical Therapy Modalities; Exercise Movement Techniques; Primary Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy in Primary Health Care

Intervention Type: 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.

B

Group B was treated with the GDS Method (muscular and articular chains physiotherapy method)

Group Type: EXPERIMENTAL

GDS Method (muscular chains physical therapy method)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agencia Lain Entralgo

OTHER_GOV

Sponsor Role: collaborator

Public Health Service of Madrid

OTHER

Sponsor Role: collaborator

Carlos III Health Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Carlos III Health Institute. General Director for evaluation and research

Principal Investigators

José L Chicharro, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

Complutense University

Madrid, Spain/Madrid, Spain

Countries

Spain

References

Kovacs FM, Abraira V, Zamora J, Teresa Gil del Real M, Llobera J, Fernandez C, Bauza JR, Bauza K, Coll J, Cuadri M, Duro E, Gili J, Gestoso M, Gomez M, Gonzalez J, Ibanez P, Jover A, Lazaro P, Llinas M, Mateu C, Mufraggi N, Muriel A, Nicolau C, Olivera MA, Pascual P, Perello L, Pozo F, Revuelta T, Reyes V, Ribot S, Ripoll J, Ripoll J, Rodriguez E; Kovacs-Atencion Primaria Group. Correlation between pain, disability, and quality of life in patients with common low back pain. Spine (Phila Pa 1976). 2004 Jan 15;29(2):206-10. doi: 10.1097/01.BRS.0000107235.47465.08.

Reference Type: BACKGROUND

PMID: 14722416 (View on PubMed)

Other Identifiers

PI051650

Identifier Type: -

Identifier Source: secondary_id

LA2007PISINISCIII77

Identifier Type: -

Identifier Source: secondary_id

PI051650

Identifier Type: -

Identifier Source: org_study_id