Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care - Full Text View

Sponsor:	Kovacs Foundation
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT01060280

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:

Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. Epub 2004 Sep 17.

Rivero-Arias O, Gray A, Frost H, Lamb SE, Stewart-Brown S. Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain. Spine (Phila Pa 1976). 2006 May 20;31(12):1381-7.

Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, Barnett J, Ballard K, Oxford F, Smith P, Yardley L, Hollinghurst S, Sharp D. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain. BMJ. 2008 Aug 19;337:a884.

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 February 09, 2012