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Clinical Trials/NCT01993355
NCT01993355
Completed
Not Applicable

A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country66 target enrollmentMarch 2013
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
66
Locations
1
Primary Endpoint
The SF-12v2 Health Status Questionnaire (change is being assessed)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.

Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.

For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).

Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Non-specific chronic (\> 6 months of evolution) low back pain diagnosis
  • Ability to read and speak in Spanish

Exclusion Criteria

  • Addictive behaviors (DAST-10 \> 3, alcoholism, drug addiction or other drug abuse)
  • Psychiatric contraindications (BDI \> 15 or other severe psychiatric disorder not stabilized)
  • Neurological impairment
  • No mental competence (MEC \< 23)
  • Fibromyalgia and/or chronic fatigue

Outcomes

Primary Outcomes

The SF-12v2 Health Status Questionnaire (change is being assessed)

Time Frame: Baseline, 6 and 12 months

The SF-12 measures health-related quality of life including items from various domains both physical and psychological.

Secondary Outcomes

  • Oswestry-15 Disability Index(Baseline, 6 and 12 months)
  • VAS for Self-perceived Pain(Baseline, 6 and 12 months)

Study Sites (1)

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