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

Kovacs Foundation

Status: Completed

Conditions: Chronic Nonspecific Low Back Pain; Subacute Nonspecific Low Back Pain

Treatments: Other: Individual GDS physiotherapy; Other: Group GDS physiotherapy; Behavioral: Education on active management

Study type: Interventional

Funder types: Other

Identifiers

NCT01060280

FK-DO 30

FK-DO 10/020 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 461 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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461 participants in 3 patient groups

Education group

Active Comparator group

Description:

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

Treatment:

Other: Individual GDS physiotherapy

Other: Group GDS physiotherapy

Behavioral: Education on active management

Group GDS physiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Individual GDS physiotherapy

Other: Group GDS physiotherapy

Individual GDS physiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Individual GDS physiotherapy