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临床试验 NCT07168707 (EAET-H) 针对慢性肌肉骨骼疼痛，大麻使用目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study 8 运动
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07168707 (EAET-H)是一项针对慢性肌肉骨骼疼痛，大麻使用的干预性研究试验，目前试验状态为招募中。试验始于2025年7月9日，计划招募8名患者。该研究由Reuth Rehabilitation Hospital主导，预计于2026年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月11日。
简要概括
The goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis.
Researchers will compare patients who receive the emotional therapy along with their usual care to...
显示更多详细描述
The rising prevalence of chronic pain conditions poses a significant challenge to societies and healthcare systems globally. Despite medical advancements, many individuals continue to face chronic pain daily, with only limited success in alleviating pain and enhancing physical and emotional well-being. Furthermore, the psychological burden associated with chronic pain highlights the critical need for integrating psyc...显示更多
官方标题
A Culturally Adapted Group-Based, Emotional Awareness and Expression Therapy Intervention - Hebrew (EAET-H) for Chronic Pain Patients Treated With Medical Cannabis in Israel - A Pilot Study
疾病
慢性肌肉骨骼疼痛大麻使用出版物
关于此临床试验发表的科学文章和研究论文：- Lumley M, Ph. Emotional Awareness and Expression Therapy (EAET): A Group-Based Treatment Manual for Patients with Fibromyalgia and Related Centralized Chronic Pain Disorders.
- Lumley MA, Schubiner H. Psychological Therapy for Centralized Pain: An Integrativ...
其他研究标识符
- EAET-H
- 0017-21-RRH
NCT编号
实际开始日期
2025-07-09
最近更新发布
2025-09-11
预计完成日期
2026-01-01
计划入组人数
8
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Chronic musculoskeletal pain
Cannabis Use
Emotional Awareness and Expression Therapy
Emotional Therapy
Psychological Therapy
Group-Based
Cannabis Use
Emotional Awareness and Expression Therapy
Emotional Therapy
Psychological Therapy
Group-Based
主要目的
其他
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group-based Emotional Awareness & Expression Therapy - Hebrew (EAET-H) This pilot study will use the eight-session group EAET manual developed by Mark A. Lumley and Howard Schubiner. Several adaptations to this manual were made: a) Manual's translation to the Hebrew language; b) Adaptations to the Israeli context and setting; c) Manual's language was changed from "fibromyalgia" to "chronic pain" and adaptations were made accordingly. Group participants will receive a class syllabus and ...显示更多 | Group-based Emotional Awareness & Expression Therapy - Hebrew This pilot study will use the eight-session group EAET manual developed by Mark A. Lumley and Howard Schubiner. Several adaptations to this manual were made: a) Manual's translation to the Hebrew language; b) Adaptations to the Israeli context and setting; c) Manual's language was changed from "fibromyalgia" to "chronic pain" and adaptations were made accordingly. Group participants will receive a class syllabus and ...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Brief Pain Inventory (BPI) - 4 items of pain severity | The BPI is a self-report questionnaire used to evaluate pain severity and includes four items. These items assess the intensity of pain at its worst, least, average, and current levels. | Baseline and after eight weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Brief Pain Inventory (BPI) - 7 items of pain interference | The BPI is a self-report questionnaire used to assess the impact of pain on daily functioning. Its seven pain interference items measure how pain affects activities such as general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. | Baseline and after eight weeks |
The Hospital Anxiety and Depression Scale (HADS) | The HADS is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in non-psychiatric hospital patients. It consists of two subscales-seven items each for anxiety (HADS-A) and depression (HADS-D). | Baseline and after eight weeks |
Pain Self-Efficacy Questionnaire (PSEQ) | The PSEQ is a 10-item self-report tool designed to assess the confidence of individuals with chronic pain in performing daily activities despite their pain. | Baseline and after eight weeks |
Pain Catastrophizing Scale (PCS) | The PCS is a 13-item questionnaire that measures negative thought patterns related to pain. It assesses three components: rumination, magnification, and helplessness. Higher scores indicate greater levels of pain catastrophizing. | Baseline and after eight weeks |
Fear-Avoidance Beliefs Questionnaire (FABQ) | The Fear-Avoidance Beliefs Questionnaire (FABQ) is a self-report tool that assesses the extent to which fear and avoidance beliefs about physical activity and work contribute to a person's chronic pain. It consists of 11 items divided into two subscales: physical activity and work. | Baseline and after eight weeks |
The Satisfaction with Life Scale (SWLS) | The SWLS is a 5-item self-report questionnaire that measures overall life satisfaction. | Baseline and after eight weeks |
Toronto Alexithymia Scale (TAS) | The TAS is a 20-item self-report questionnaire that can be used to identify issues relating to alexithymia, such as difficulty identifying and describing feelings and externally oriented thinking | Baseline and after eight weeks |
The Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-report questionnaire that assesses sleep quality and disturbances over a 1-month period. It yields a global score based on seven components, including sleep duration, latency, and disturbances. | Baseline and after eight weeks |
The Fatigue Severity Scale (FSS) | The FSS is a 9-item self-report questionnaire that measures the impact of fatigue on daily functioning. | Baseline and after eight weeks |
The Patient Global Impression of Change (PGIC) | The PGIC is a single-item self-report measure that assesses a patient's overall perception of improvement or decline following treatment. | After eight weeks |
Medical cannabis consumption | Three questions regarding the frequency of cannabis use and the method of cannabis consumption. | Baseline and after eight weeks |
Health care use | Four questions regarding the medications the patient takes regularly, the treatments they receive and their frequency, and doctor visits within the past three months. | Baseline and after eight weeks |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Diagnosed with any chronic musculoskeletal pain (≥ three months in duration). widespread pain or fibromyalgia or any combination of these conditions;
- Treated with medical Cannabis;
- Physical and mental ability to participate in group discussions;
- Explicitly endorsed an interest in exploring potential emotional factors contributing to their somatic symptoms;
- Signed informed consent form
- The following conditions will be excluded: confirmed hip/knee osteoarthritis, radiculopathy, electromyography-confirmed "tunnel" syndromes, autoimmune disease that typically generates pain (e.g., rheumatoid arthritis or multiple sclerosis, inflammatory bowel disease, systemic lupus, sickle cell disease), cancer, and chronic infection associated with pain;
- Severe mental illness or psychiatric disorder such as schizophrenia, bipolar I disorder, multiple personality disorder, or dissociative identity disorder not controlled with medications. In addition, active suicide or violence risk in the past year, active severe alcohol or substance use disorder.
- Unable to fluently read or converse in Hebrew;
- Participation in any other clinical study or program focusing on psychological or behavioral intervention.
Reuth Rehabilitation Hospital特拉维夫大学研究中心联系人
联系人: Pnina Marom, M.P.H.; Ph.D. Student, +972-526134797, [email protected]
联系人: Shahar Lev-Ari, Ph.D., [email protected]
1 位于 1 个国家/地区的研究中心
Reuth Rehabilitation Hospital, Tel Aviv, 6772830, Israel
Keren Sivan-Speier, M.D, 联系人, +972-732701610, [email protected]
招募中