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

Chronic Nonspecific Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060280
• Other study ID #: FK-DO 30
• Secondary ID: FK-DO 10/020
• Status: Completed
• Phase: N/A
• First received: January 29, 2010
• Last updated: August 15, 2014
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2014
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Back Pain Research Network
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: September 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. doi: 10.1136/bmj.a884. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain, referred pain and disability		Baseline, 2, 6 and 12 months	No
Secondary	Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments		Baseline, 2, 6 and 12 months	No