Clinical trial NCT00439764: Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
Official title: Health Education vs. Health Education Plus Physical Therapy for Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low back pain, health education, physical therapy
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Consejería de Sanidad, Junta de Castilla y León
First posted: 2007-02-26
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of pain, measured at baseline, 90, and 180 days later
timeFrame: 6 months
measure: Disability, measured at baseline, 90, and 180 days later
timeFrame: 6 months
measure: Sick leave, measured at baseline, 90, and 180 days later
timeFrame: 6 months
Secondary outcomes:
measure: Fear avoidance beliefs, measured at baseline, 90, and 180 days later
timeFrame: 6 months
measure: Quality of life, measured at baseline, 90, and 180 days later
timeFrame: 6 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Servicio de Atención Primaria del SACYL
state: Castilla y León
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_CHAIR
affiliation: Consejería de Sanidad, 47071 Valladolid, Spain
name: Celia Albaladejo, MD
role: STUDY_DIRECTOR
affiliation: Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain
name: Rafael del Pino, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.
citation: Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8. doi: 10.1001/archinte.161.8.1081.
citation: Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17.
citation: Albaladejo C, Kovacs FM, Royuela A, del Pino R, Zamora J; Spanish Back Pain Research Network. The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial. Spine (Phila Pa 1976). 2010 Mar 1;35(5):483-96. doi: 10.1097/BRS.0b013e3181b9c9a7.