Clinical trial NCT00624533: Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low back Pain
Physical Therapy Modalities
Exercise Movement Techniques
Primary Health Care
Lead sponsor: Carlos III Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Agencia Lain Entralgo
name: Public Health Service of Madrid
First posted: 2008-02-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intensity of pain (VAS)
timeFrame: At baseline, immediately after intervention,at 3-months and 6-months
Secondary outcomes:
measure: Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region
timeFrame: At baseline, immediately after intervention,at 3-months and 6-months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Complutense University
state: Spain/Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: José L Chicharro, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.