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OpenTrials
Completed

NCT Number: NCT00439764

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

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.

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Key information

Conditions

Low Back Pain Adherence Interventions Back Pain Behavior Health Behavior Health Education Medication Adherence Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Servicio de Atención Primaria del SACYL

Valladolid, Castille and León, 47005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General health talk

Behavioral

Routine clinical practice and talk on general health

Handout of The Back Book

Behavioral

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

Back exercise

Behavioral

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

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Collaborators

  • Consejería de Sanidad, Junta de Castilla y León

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2007
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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