NCT00439764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for phase_2 low-back-pain

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 28, 2009

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

February 23, 2007

Last Update Submit

May 27, 2009

Conditions

Low Back Pain

Keywords

Low back pain, health education, physical therapy

Outcome Measures

Primary Outcomes (3)

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

    6 months

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

    6 months

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

    6 months

Secondary Outcomes (2)

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

    6 months

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

    6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Routine clinical practice and talk on general health

Behavioral: General health talkBehavioral: Handout of The Back BookBehavioral: Back exercise

2

ACTIVE COMPARATOR

Talk on back health and handout of The Back Book

Behavioral: Handout of The Back BookBehavioral: Back exercise

3

ACTIVE COMPARATOR

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

Behavioral: Back exercise

Interventions

General health talkBEHAVIORAL

Routine clinical practice and talk on general health

1
Handout of The Back BookBEHAVIORAL

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

12
Back exerciseBEHAVIORAL

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

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consultation for low back pain, with or without referred or radiated pain; no signs of systemic disease or criteria for surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Atención Primaria del SACYL

Valladolid, Castille and León, 47005, Spain

Location

Related Publications (4)

  • 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.

    PMID: 10626311BACKGROUND

  • 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.

    PMID: 11322842BACKGROUND

  • 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.

    PMID: 15377573BACKGROUND

  • 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.

    PMID: 20147875DERIVED

Related Links

MeSH Terms

Conditions

Low Back PainHealth Education

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, 07012, Spain

    STUDY CHAIR

  • Celia Albaladejo, MD

    Consejería de Sanidad, 47071 Valladolid, Spain

    STUDY DIRECTOR

  • Rafael del Pino, PT

    Centro de Especialidades de Fisioterapia, 47014 Valladolid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

May 28, 2009

Record last verified: 2008-11

Locations

ES(1)