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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439764
Enrollment
680
Registered
2007-02-26
Start date
2007-03-31
Completion date
2008-09-30
Last updated
2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, health education, physical therapy

Brief summary

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.

Interventions

Routine clinical practice and talk on general health

BEHAVIORALHandout of The Back Book

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

BEHAVIORALBack exercise

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

Sponsors

Consejería de Sanidad, Junta de Castilla y León
CollaboratorUNKNOWN
Kovacs Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Intensity of pain, measured at baseline, 90, and 180 days later6 months
Disability, measured at baseline, 90, and 180 days later6 months
Sick leave, measured at baseline, 90, and 180 days later6 months

Secondary

MeasureTime frame
Fear avoidance beliefs, measured at baseline, 90, and 180 days later6 months
Quality of life, measured at baseline, 90, and 180 days later6 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026