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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Kovacs Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT01060280
First received: January 29, 2010
Last updated: June 26, 2011
Last verified: June 2011
History of Changes
  Purpose

A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and Individual GDS are effective and cost-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, habitual physical activity and cost. The questionnaires to be used are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.


Condition Intervention
Subacute Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
 Behavioral: Education on active management
Other: Group GDS physiotherapy
Other: Individual GDS physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Effectiveness of Group GDS treatment and Individual GDS treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost/effectiveness of Group GDS and Individual GDS treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 462
Study Start Date: May 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • low back pain of more than 14 days duration

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060280

Contacts
Contact: Francisco M Kovacs, MD, PhD 34 971 720809 fmkovacs@kovacs.org
Contact: Mario Gestoso, MD 34 971 720809 mgestoso@kovacs.org

Locations
Spain
Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS) Recruiting
Madrid, Spain, 28016
Contact: María Jose Díaz-Arribas, PhT, PhD         mjdiazar@med.ucm.es    
Contact: Francisco M Kovacs, MD, PhD     +34971720809        
Sponsors and Collaborators
Kovacs Foundation
Investigators
Study Director: Francisco M Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, Spain
Principal Investigator: Mario Gestoso, MD Kovacs Foundation, Palma de Mallorca, Spain
  More Information

Publications:

Responsible Party: Francisco Kovacs, Director Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT01060280     History of Changes
Other Study ID Numbers: FK-DO 30, FK-DO 10/020
Study First Received: January 29, 2010
Last Updated: June 26, 2011
Health Authority: Spain: Spanish Back Pain Research Network

Keywords provided by Kovacs Foundation:
low back pain
physiotherapy
exercise
active management

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013