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

August 15, 2014 updated by: Francisco M. Kovacs, Kovacs Foundation

The Effectiveness of the Physiotherapy Techniques Group GDS and Individual GDS for the Treatment of Nonspecific Low Back Pain in Primary Care. A Cluster, Randomized, Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28016
        • Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with nonspecific low back pain by the primary care physician
  • more than or equal to 18 and less than or equal to 65 years of age

Exclusion Criteria:

  • not signing the informed consent form
  • pregnancy
  • diagnosis of inflammatory rheumatologic disease, cancer, or fibromyalgia
  • signs for suspicion of fibromyalgia
  • having red flags for systemic disease
  • presenting criteria for urgent referral to surgery
  • presenting criteria for non-urgent referral to surgery
  • inability to read, understand, or follow verbal orders (dementia,blindness, doesn´t know how to read)
  • bedridden
  • having received physiotherapy in last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Education group
Routine clinical practice (includes usual physiotherapy)plus education on active management.
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.
Active Comparator: Group GDS physiotherapy
Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)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.
Active Comparator: Individual GDS physiotherapy
Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Low back pain, referred pain and disability
Time Frame: Baseline, 2, 6 and 12 months
Baseline, 2, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments
Time Frame: Baseline, 2, 6 and 12 months
Baseline, 2, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kovacs Foundation

Investigators

  • Principal Investigator: Mario Gestoso, MD, Kovacs Foundation, Palma de Mallorca, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK-DO 30
  • FK-DO 10/020 (Other Identifier: Hospital Doce de Octubre, Madrid, Spain)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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