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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439764
• Other study ID #: FK-JCL-14
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2007
• Last updated: May 27, 2009
• Start date: March 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Consejería de Sanidad, Junta de Castilla y León; Spain: Spanish Back Pain Research Network (REIDE)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• General health talk
Routine clinical practice and talk on general health
• Handout of The Back Book
Talk on health of the back and handout of The Back Book
• Back exercise
Routine clinical practice, talk on back health, handout of The Back Book and back exercise

Locations

Country	Name	City	State
Spain	Servicio de Atención Primaria del SACYL	Valladolid	Castilla y León

Sponsors (2)

Lead Sponsor	Collaborator
Kovacs Foundation	Consejería de Sanidad, Junta de Castilla y León

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. Epub 2004 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain, measured at baseline, 90, and 180 days later		6 months	No
Primary	Disability, measured at baseline, 90, and 180 days later		6 months	No
Primary	Sick leave, measured at baseline, 90, and 180 days later		6 months	No
Secondary	Fear avoidance beliefs, measured at baseline, 90, and 180 days later		6 months	No
Secondary	Quality of life, measured at baseline, 90, and 180 days later		6 months	No

External Links

•   Spanish Back Pain Research Network site that describes objectives and projects of its members.