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Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993355
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: Physiotherapy Other: Intervention 1 Behavioral: Intervention 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: TAU
Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.
Other: Physiotherapy
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.
Other Name: Treatment as usual (TAU)

Experimental: Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
Other: Physiotherapy
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.
Other Name: Treatment as usual (TAU)

Other: Intervention 1
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.
Other Name: Relaxation techniques-sophrology

Experimental: Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
Other: Physiotherapy
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.
Other Name: Treatment as usual (TAU)

Behavioral: Intervention 2
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.
Other Name: CBT




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. VAS for Self-perceived Pain [ Time Frame: Baseline, 6 and 12 months ]
    Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.

  2. Oswestry-15 Disability Index [ Time Frame: Baseline, 6 and 12 months ]
    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).


Other Outcome Measures:
  1. LISAT-8 [ Time Frame: Baseline, 6 and 12 months ]
    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.

  2. STAI [ Time Frame: Baseline, 6 and 12 months ]
    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.

  3. BDI-13 [ Time Frame: Baseline, 6 and 12 months ]
    The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  4. PSQI [ Time Frame: Baseline, 6 and 12 months ]
    The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.

  5. CAD [ Time Frame: Baseline and 12 months ]
    The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.

  6. TAS-20 [ Time Frame: Baseline and 12 months ]
    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).

  7. PSS-14 [ Time Frame: Baseline and 12 months ]
    The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.

  8. DUKE-11 [ Time Frame: Baseline and 12 months ]
    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.

  9. VAS for patient satisfaction with treatment received [ Time Frame: Baseline, 6 and 12 months ]
    Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.

  10. Medical and demographics [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993355


Locations
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Spain
Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Carmina Castellano-Tejedor, PhD Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
Study Director: Elisa Barnola-Serra, MD Hospital Vall d'Hebron
Study Chair: Gemma Costa-Requena, MsC Hospital Vall d'Hebron
Study Chair: Pilar Lusilla-Palacios, MD, PhD Hospital Vall d'Hebron
Study Chair: Alex Ginés-Puertas Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Study Chair: Laura Camprubí-Roca Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Study Chair: Mª Lluisa Torrent-Bertran, MD Hospital Vall d'Hebron
Study Chair: Ana Palacios-González Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
Study Chair: Tamara Biedermann-Villagra, MD Hospital Vall d'Hebron
Publications of Results:
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
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.

Other Publications:
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.

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01993355    
Other Study ID Numbers: CLBP-PT_ATR_274-2012
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
non-specific chronic low back pain,
health-related quality of life,
physioterapy,
sophrology,
cognitive-behavioral therapy,
motivational interviewing
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations