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

NCT ID: NCT00439764

Last Updated: 2009-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Routine clinical practice and talk on general health

Group Type ACTIVE_COMPARATOR

General health talk

Intervention Type BEHAVIORAL

Routine clinical practice and talk on general health

Handout of The Back Book

Intervention Type BEHAVIORAL

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

Back exercise

Intervention Type BEHAVIORAL

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

2

Talk on back health and handout of The Back Book

Group Type ACTIVE_COMPARATOR

Handout of The Back Book

Intervention Type BEHAVIORAL

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

Back exercise

Intervention Type BEHAVIORAL

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

3

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

Group Type ACTIVE_COMPARATOR

Back exercise

Intervention Type BEHAVIORAL

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

Interventions

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General health talk

Routine clinical practice and talk on general health

Intervention Type BEHAVIORAL

Handout of The Back Book

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

Intervention Type BEHAVIORAL

Back exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consejería de Sanidad, Junta de Castilla y León

UNKNOWN

Sponsor Role collaborator

Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Consejería de Sanidad, Junta de Castilla y León

Principal Investigators

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Francisco M Kovacs, MD, PhD

Role: STUDY_CHAIR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Celia Albaladejo, MD

Role: STUDY_DIRECTOR

Consejería de Sanidad, 47071 Valladolid, Spain

Rafael del Pino, PT

Role: PRINCIPAL_INVESTIGATOR

Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain

Locations

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Servicio de Atención Primaria del SACYL

Valladolid, Castille and León, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 10626311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11322842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15377573 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20147875 (View on PubMed)

Related Links

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http://www.reide.org

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

Other Identifiers

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FK-JCL-14

Identifier Type: -

Identifier Source: org_study_id

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