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

Kovacs Foundation680 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

680

Conditions

Low Back Pain

Interventions

General health talkBEHAVIORAL

Routine clinical practice and talk on general health

Handout of The Back BookBEHAVIORAL

Talk on health of the back and handout of The Back Book

Back exerciseBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Servicio de Atención Primaria del SACYL

Valladolid, Castille and León, Spain

Outcomes

Primary Outcomes

Intensity of pain, measured at baseline, 90, and 180 days later

Time frame: 6 months

Disability, measured at baseline, 90, and 180 days later

Time frame: 6 months

Sick leave, measured at baseline, 90, and 180 days later

Time frame: 6 months

Secondary Outcomes

Fear avoidance beliefs, measured at baseline, 90, and 180 days later

Time frame: 6 months

Quality of life, measured at baseline, 90, and 180 days later

Time frame: 6 months

Data from ClinicalTrials.gov

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