Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona、スペイン、08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：TAU
Control group.
Treatment as usual (TAU): Physiotherapy program for CLBP.
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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.
他の名前：
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実験的：Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
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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.
他の名前：
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.
他の名前：
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実験的：Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
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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.
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The SF-12v2 Health Status Questionnaire (change is being assessed)
時間枠：Baseline, 6 and 12 months
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The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
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Baseline, 6 and 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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VAS for Self-perceived Pain
時間枠：Baseline, 6 and 12 months
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Visual Analogue Scale to rate self-perceived pain.
Recall period: last 4 weeks.
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Baseline, 6 and 12 months
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Oswestry-15 Disability Index
時間枠：Baseline, 6 and 12 months
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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).
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Baseline, 6 and 12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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LISAT-8
時間枠：Baseline, 6 and 12 months
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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.
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Baseline, 6 and 12 months
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STAI
時間枠：Baseline, 6 and 12 months
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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.
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Baseline, 6 and 12 months
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BDI-13
時間枠：Baseline, 6 and 12 months
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The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
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Baseline, 6 and 12 months
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PSQI
時間枠：Baseline, 6 and 12 months
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The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
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Baseline, 6 and 12 months
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CAD
時間枠：Baseline and 12 months
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The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
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Baseline and 12 months
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TAS-20
時間枠：Baseline and 12 months
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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).
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Baseline and 12 months
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PSS-14
時間枠：Baseline and 12 months
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The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
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Baseline and 12 months
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DUKE-11
時間枠：Baseline and 12 months
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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.
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Baseline and 12 months
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VAS for patient satisfaction with treatment received
時間枠：Baseline, 6 and 12 months
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Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
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Baseline, 6 and 12 months
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Medical and demographics
時間枠：Baseline
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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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Baseline
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協力者と研究者
捜査官
- 主任研究者：Carmina Castellano-Tejedor, PhD、Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- スタディディレクター：Elisa Barnola-Serra, MD、Hospital Vall d'Hebron
- スタディチェア：Gemma Costa-Requena, MsC、Hospital Vall d'Hebron
- スタディチェア：Pilar Lusilla-Palacios, MD, PhD、Hospital Vall d'Hebron
- スタディチェア：Alex Ginés-Puertas、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- スタディチェア：Laura Camprubí-Roca、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- スタディチェア：Mª Lluisa Torrent-Bertran, MD、Hospital Vall d'Hebron
- スタディチェア：Ana Palacios-González、Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- スタディチェア：Tamara Biedermann-Villagra, MD、Hospital Vall d'Hebron
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CLBP-PT_ATR_274-2012
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性の痛みの臨床試験
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Dexa Medica Group完了