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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU | Active Comparator | Control group. Treatment as usual (TAU): Physiotherapy program for CLBP. |
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| Intervention 1 Relaxation techniques-sophrology | Experimental | Intervention group 1: TAU + relaxation techniques-sophrology program. |
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| Intervention 2 Cognitive-behavioral therapy | Experimental | Intervention group 2: TAU + cognitive-behavioral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| VAS for Self-perceived Pain | Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks. | Baseline, 6 and 12 months |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| LISAT-8 | 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. | Baseline, 6 and 12 months |
| STAI |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmina Castellano-Tejedor, PhD | Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron | Principal Investigator |
| Elisa Barnola-Serra, MD | Hospital Vall d'Hebron | Study Director |
| 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 CamprubÃ-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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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, CamprubÃ-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. | ||
| Result | Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Biedermann-Villagra, T., Barnola-Serra, E. Calidad del sueño en pacientes con lumbalgia crónica inespecÃfica. Rehabilitación 48(4): 219-225, 2014. DOI: 10.1016/j.rh.2014.05.003 | ||
| Result | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
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|
| Intervention 1 | Other | 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. |
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| Intervention 2 | Behavioral | 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. |
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| 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.
| Baseline, 6 and 12 months |
| BDI-13 | The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression. | Baseline, 6 and 12 months |
| PSQI | The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month. | Baseline, 6 and 12 months |
| CAD | The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample. | Baseline and 12 months |
| TAS-20 | 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). | Baseline and 12 months |
| PSS-14 | The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful. | Baseline and 12 months |
| DUKE-11 | 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. | Baseline and 12 months |
| VAS for patient satisfaction with treatment received | Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes. | Baseline, 6 and 12 months |
| Medical and demographics | 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. | Baseline |