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

NCT00624533 | Completed Phase 2 DMC

• 2 other identifiers: PI051650LA2007PISINISCIII77
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intensity of pain (VAS)

  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

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

Study Arms (2)

A

ACTIVE COMPARATOR

Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)

Behavioral: Conventional Physical Therapy in Primary Health Care

B

EXPERIMENTAL

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

Behavioral: GDS Method (muscular chains physical therapy method)

Interventions

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.

B

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.

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos III Health Institute: lead
• Agencia Lain Entralgo: collaborator
• Public Health Service of Madrid: collaborator

Study Sites (1)

Complutense University

Madrid, Spain/Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 14722416 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• José L Chicharro, MD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: January 1, 2006
• Primary Completion: March 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 27, 2008

Record last verified: 2008-02

Locations

ES (1)