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

Not Applicable

Completed

• Conditions: Subacute Nonspecific Low Back Pain; Chronic Nonspecific Low Back Pain
• Interventions: Behavioral: Education on active management; Other: Individual GDS physiotherapy; Other: Group GDS physiotherapy

• Registration Number: NCT01060280
• Lead Sponsor: Kovacs Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Start: 2010-05
• Primary Completion: 2011-10
• Study Completion: 2012-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 461

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education group	Group GDS physiotherapy	Routine clinical practice (includes usual physiotherapy)plus education on active management.
Education group	Education on active management	Routine clinical practice (includes usual physiotherapy)plus education on active management.
Individual GDS physiotherapy	Individual GDS physiotherapy	Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management.
Education group	Individual GDS physiotherapy	Routine clinical practice (includes usual physiotherapy)plus education on active management.
Group GDS physiotherapy	Group GDS physiotherapy	Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management.
Group GDS physiotherapy	Individual GDS physiotherapy	Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management.

Primary Outcome Measures

Name	Time	Method
Low back pain, referred pain and disability	Baseline, 2, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS); 🇪🇸 Madrid, Spain