Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy
Intervention 1
Intervention 2
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring non-specific chronic low back pain,, health-related quality of life,, physioterapy,, sophrology,, cognitive-behavioral therapy,, motivational interviewing
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
Sites / Locations
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
TAU
Intervention 1 Relaxation techniques-sophrology
Intervention 2 Cognitive-behavioral therapy
Arm Description
Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.
Intervention group 1: TAU + relaxation techniques-sophrology program.
Intervention group 2: TAU + cognitive-behavioral therapy.
Outcomes
Primary Outcome Measures
The SF-12v2 Health Status Questionnaire (change is being assessed)
The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
Secondary Outcome Measures
VAS for Self-perceived Pain
Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.
Oswestry-15 Disability Index
The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life).
Full Information
NCT ID
NCT01993355
First Posted
November 11, 2013
Last Updated
June 15, 2015
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01993355
Brief Title
Chronic Low Back Pain: A Multidisciplinary Approach
Acronym
CLBP-HUVH
Official Title
A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
non-specific chronic low back pain,, health-related quality of life,, physioterapy,, sophrology,, cognitive-behavioral therapy,, motivational interviewing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.
Arm Title
Intervention 1 Relaxation techniques-sophrology
Arm Type
Experimental
Arm Description
Intervention group 1: TAU + relaxation techniques-sophrology program.
Arm Title
Intervention 2 Cognitive-behavioral therapy
Arm Type
Experimental
Arm Description
Intervention group 2: TAU + cognitive-behavioral therapy.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Intervention Type
Other
Intervention Name(s)
Intervention 1
Other Intervention Name(s)
Relaxation techniques-sophrology
Intervention Description
Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.
Intervention Type
Behavioral
Intervention Name(s)
Intervention 2
Other Intervention Name(s)
CBT
Intervention Description
Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.
Primary Outcome Measure Information:
Title
The SF-12v2 Health Status Questionnaire (change is being assessed)
Description
The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
Time Frame
Baseline, 6 and 12 months
Secondary Outcome Measure Information:
Title
VAS for Self-perceived Pain
Description
Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.
Time Frame
Baseline, 6 and 12 months
Title
Oswestry-15 Disability Index
Description
The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life).
Time Frame
Baseline, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
LISAT-8
Description
The LISAT is a domain-specific measure of life satisfaction, which corresponds to Box E (subjective evaluations and reactions; life satisfaction) of Dijker's Model.
Time Frame
Baseline, 6 and 12 months
Title
STAI
Description
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to screen anxiety and to distinguish it from depressive syndromes.
Time Frame
Baseline, 6 and 12 months
Title
BDI-13
Description
The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time Frame
Baseline, 6 and 12 months
Title
PSQI
Description
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
Time Frame
Baseline, 6 and 12 months
Title
CAD
Description
The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
Time Frame
Baseline and 12 months
Title
TAS-20
Description
The Toronto Alexithymia Scale (TAS) 20-item is one of the most commonly used measures of alexithymia (people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally).
Time Frame
Baseline and 12 months
Title
PSS-14
Description
The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
Time Frame
Baseline and 12 months
Title
DUKE-11
Description
The DUKE 11-item social support questionnaire measures an individual's perception of the amount and type of personal social support. The original instrument included 14 items, grouped into 4 subscales: Quantity of Support, Confidant Support, Affective Support, and Instrumental Support.
Time Frame
Baseline and 12 months
Title
VAS for patient satisfaction with treatment received
Description
Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
Time Frame
Baseline, 6 and 12 months
Title
Medical and demographics
Description
Medical (medical and psychopathological history, physical exploration of LBP and possible substance abuse or other toxic habits such as alcohol or tobacco) and demographics (age, gender, immediate family network, education, job and SES) of patients are collected according to standard procedures.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmina Castellano-Tejedor, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisa Barnola-Serra, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gemma Costa-Requena, MsC
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pilar Lusilla-Palacios, MD, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alex Ginés-Puertas
Organizational Affiliation
Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laura Camprubí-Roca
Organizational Affiliation
Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mª Lluisa Torrent-Bertran, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ana Palacios-González
Organizational Affiliation
Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamara Biedermann-Villagra, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
Citation
Group of pain for patients with chronic low back pain: A multidisciplinary intervention. Lusilla-Palacios, P, Castellano-Tejedor, C, Barnola-Serra, E, Ramos-Rondón, C, Biedermann-Villagra, T, Torrent-Bertran, M.L, Costa-Requena, G, Camprubí-Roca, L, Palacios-González, A, Cuxart-Fina, A, Ginés-Puertas, A, Bosch-Graupera, A. Poster communication on the 21th European Congress of Psychiatry, Nice, France, 25-29/05/2010.
Results Reference
background
Citation
Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Biedermann-Villagra, T., Barnola-Serra, E. Calidad del sueño en pacientes con lumbalgia crónica inespecífica. Rehabilitación 48(4): 219-225, 2014. DOI: 10.1016/j.rh.2014.05.003
Results Reference
result
Citation
Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Barnola-Serra, E. Calidad de vida en pacientes con dolor lumbar crónico: efectos de un programa de intervención multidisciplinar a los 6 meses de seguimiento. Comunicació tipus pòster presentada a les II Jornades BiblioPro del Parc de Recerca Biomédica de Barcelona, Barcelona 19 de febrer de 2015.
Results Reference
result
Learn more about this trial
Chronic Low Back Pain: A Multidisciplinary Approach
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