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Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care

NCT01060280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2014-08-18

No results posted yet for this study

Summary

A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will be the participating physiotherapy departments in primary care who treat patients with low back pain. In each physiotherapy department there will be 3 groups: education group, Group GDS and Individual GDS. Patients will be followed for 12 months. Variables will be: demographic,intensity of pain, disability, quality of life, patient satisfaction, medication intake for current episode, non-pharmacologic treatment for current episode, co-morbidity, diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.

Conditions

  • Subacute Nonspecific Low Back Pain
  • Chronic Nonspecific Low Back Pain

Interventions

BEHAVIORAL

Education on active management

Routine clinical practice plus education on active management.

OTHER

Group GDS physiotherapy

Routine clinical practice (which will be substituted by Group GDS) plus education on active management.

OTHER

Individual GDS physiotherapy

Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.

Sponsors & Collaborators

  • Kovacs Foundation

    lead OTHER

Principal Investigators

  • Francisco M Kovacs, MD, PhD · Kovacs Foundation, Palma de Mallorca, Spain

  • Mario Gestoso, MD · Kovacs Foundation, Palma de Mallorca, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-10-31
Completion
2012-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060280 on ClinicalTrials.gov