Chronic Pain
Conditions
Keywords
non-specific chronic low back pain,, health-related quality of life,, physioterapy,, sophrology,, cognitive-behavioral therapy,, motivational interviewing
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.
Interventions
OTHERPhysiotherapy
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.
OTHERIntervention 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.
BEHAVIORALIntervention 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.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The SF-12v2 Health Status Questionnaire (change is being assessed) | Baseline, 6 and 12 months | The SF-12 measures health-related quality of life including items from various domains both physical and psychological. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS for Self-perceived Pain | Baseline, 6 and 12 months | Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks. |
| Oswestry-15 Disability Index | 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
| Measure | Time frame | Description |
|---|---|---|
| PSQI | Baseline, 6 and 12 months | The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month. |
| CAD | Baseline and 12 months | The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample. |
| TAS-20 | 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). |
| LISAT-8 | 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. |
| DUKE-11 | 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. |
| VAS for patient satisfaction with treatment received | Baseline, 6 and 12 months | Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes. |
| Medical and demographics | 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. |
| PSS-14 | 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. |
| STAI | 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. |
| BDI-13 | 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. |
Countries
Spain
Outcome results
None listed