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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

General health talk

Handout of The Back Book

Back exercise

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, health education, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Servicio de Atención Primaria del SACYL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Routine clinical practice and talk on general health

Talk on back health and handout of The Back Book

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

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00439764

First Posted

February 23, 2007

Last Updated

May 27, 2009

Sponsor

Kovacs Foundation

Collaborators

Consejería de Sanidad, Junta de Castilla y León

1. Study Identification

Unique Protocol Identification Number

NCT00439764

Brief Title

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

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kovacs Foundation

Collaborators

Consejería de Sanidad, Junta de Castilla y León

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Low back pain, health education, physical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Routine clinical practice and talk on general health

Arm Title

Arm Type

Active Comparator

Arm Description

Talk on back health and handout of The Back Book

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

General health talk

Intervention Description

Routine clinical practice and talk on general health

Intervention Type

Behavioral

Intervention Name(s)

Handout of The Back Book

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Back exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco M Kovacs, MD, PhD

Organizational Affiliation

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Celia Albaladejo, MD

Organizational Affiliation

Consejería de Sanidad, 47071 Valladolid, Spain

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rafael del Pino, PT

Organizational Affiliation

Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Servicio de Atención Primaria del SACYL

City

Valladolid

State/Province

Castilla y León

ZIP/Postal Code

47005

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

10626311

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.

Results Reference

background

PubMed Identifier

11322842

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.

Results Reference

background

PubMed Identifier

15377573

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.

Results Reference

background

PubMed Identifier

20147875

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.

Results Reference

derived

Links:

URL

http://www.reide.org

Description

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

Learn more about this trial

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

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