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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

GDS Method (muscular chains physical therapy method)

Conventional Physical Therapy in Primary Health Care

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back Pain, Physical Therapy Modalities, Exercise Movement Techniques, Primary Health Care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Complutense University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)

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

Outcomes

Primary Outcome Measures

Intensity of pain (VAS)

Secondary Outcome Measures

Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region

Full Information

NCT ID

NCT00624533

First Posted

February 19, 2008

Last Updated

February 26, 2008

Sponsor

Carlos III Health Institute

Collaborators

Agencia Lain Entralgo, Public Health Service of Madrid

1. Study Identification

Unique Protocol Identification Number

NCT00624533

Brief Title

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

Acronym

GDS

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Carlos III Health Institute

Collaborators

Agencia Lain Entralgo, Public Health Service of Madrid

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

GDS Method (muscular chains physical therapy method)

Intervention Description

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

Intervention Name(s)

Conventional Physical Therapy in Primary Health Care

Intervention Description

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 Outcome Measure Information:

Title

Intensity of pain (VAS)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José L Chicharro, MD

Organizational Affiliation

Universidad Complutense de Madrid

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complutense University

City

Madrid

State/Province

Spain/Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

14722416

Citation

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.

Results Reference

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

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