Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients

Kovacs Foundation

Status and phase: Completed; Phase 2

Conditions: Low Back Pain

Treatments: Behavioral: Back exercise; Behavioral: General health talk; Behavioral: Handout of The Back Book

Study type: Interventional

Funder types: Other

Identifiers

NCT00439764

FK-JCL-14

Details and patient eligibility

About

The primary purpose of this study is to assess the effectiveness of a brief educational program and of an additional program in physical therapy, for the treatment of low back pain in Primary Care of the Spanish National Health Service. This is a controlled, cluster randomized community trial.

Enrollment: 680 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.

Exclusion criteria

• Inability to fill out the questionnaires (blindness, dementia, illiteracy; total habitual prostration;
• Diagnosis of rheumatologic inflammatory disease, fibromyalgia or cancer in last 5 years;
• Suspicion of fibromyalgia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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680 participants in 3 patient groups

1

Active Comparator group

Description:

Routine clinical practice and talk on general health

Treatment:

Behavioral: General health talk

Behavioral: Back exercise

Behavioral: Handout of The Back Book

2

Active Comparator group

Description:

Talk on back health and handout of The Back Book

Treatment:

Behavioral: Back exercise

Behavioral: Handout of The Back Book

3

Active Comparator group

Description:

Routine clinical practice, talk on back health, handout of The Back Book and back exercise

Treatment:

Behavioral: Back exercise