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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Subacute Nonspecific Low Back Pain Chronic Nonspecific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Education group

Routine clinical practice (includes usual physiotherapy)plus education on active management.

Group Type ACTIVE_COMPARATOR

Education on active management

Intervention Type BEHAVIORAL

Routine clinical practice plus education on active management.

Group GDS physiotherapy

Intervention Type OTHER

Routine clinical practice (which will be substituted by Group GDS) plus education on active management.

Individual GDS physiotherapy

Intervention Type OTHER

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

Group GDS physiotherapy

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

Group Type ACTIVE_COMPARATOR

Group GDS physiotherapy

Intervention Type OTHER

Routine clinical practice (which will be substituted by Group GDS) plus education on active management.

Individual GDS physiotherapy

Intervention Type OTHER

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

Individual GDS physiotherapy

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

Group Type ACTIVE_COMPARATOR

Individual GDS physiotherapy

Intervention Type OTHER

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

Interventions

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Education on active management

Routine clinical practice plus education on active management.

Intervention Type BEHAVIORAL

Group GDS physiotherapy

Routine clinical practice (which will be substituted by Group GDS) plus education on active management.

Intervention Type OTHER

Individual GDS physiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No