Mindfulness-Based Pain Management (MBPM) for Patients With Chronic Musculoskeletal Pain: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- pain acceptance
研究概览
简要总结
Mindfulness-Based Pain Management (MBPM) is an eight-week behavioral medicine program. Based on the well-known Mindfulness-Based Stress Reduction (MBSR) program, it was specifically developed as an intervention for chronic pain. During the program, mindfulness exercises, gentle body exercises and body awareness and breathing exercises, as well as pain regulation methods are taught.
Initial studies suggest efficacy of the program with regard to chronic pain, however, the effect of the standardized program in patients with chronic musculoskeletal pain has not yet been investigated in a clinical study. Therefore, the aim of this study is to investigate the MBPM program on pain acceptance in patients with chronic musculoskeletal pain. To this end, 40 patients with chronic (specific and non-specific) musculoskeletal pain will be randomly assigned to two study conditions. The intervention group will receive MBPM sessions of 150 minutes once a week over the course of 8 weeks, while the control group will receive standard therapy (waiting list). We hypothesize that patients will indicate a significantly higher pain acceptance after completing the program compared to patients not participating in the program.
详细描述
The purpose of this study is to investigate the efficacy of a structured 8-week Mindfulness-Based Pain Management (MBPM) program, based on the Breathworks method by Vidyamala Burch, in addition to standard therapy compared to standard therapy alone in terms of pain acceptance in patients with chronic musculoskeletal pain.
The study is a monocentric, single-blinded (data collector), randomized study with 2 study arms. Study center is the Clinic for Natural and Integrative Medicine, Evang. Kliniken Essen-Mitte.
Patients will be recruited via study calls on the clinic website as well as via press advertisements (see appendix). In addition, former patients who have been treated at the Clinic for Natural and Integrative Medicine for chronic musculoskeletal pain will be contacted. If a patient reports interest in the study, he/she will first be screened by telephone for the presence of the inclusion and exclusion criteria. In case of potential eligibility, patients are invited to the Study Center. All patients will be informed by a study physician and assessed for suitability to participate in the study.
The inclusion and exclusion criteria are assessed on site by the study physician by means of a detailed general medical history and an orienting clinical-neurological examination.
Eligible patients will be assigned to one of the two study arms after completion of measurements at week 0 via non-stratified block randomization with randomly varying block length. Establishing the randomization sequence and ensuring blinded assignment will be done via central randomization through RedCap software by an external researcher who will have no patient contact throughout the study. Neither the patients nor the study physician nor the study coordinators will have any insight into the randomization sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data collectors will be blinded. Blinding of study participants is not possible due to the study design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic specific or nonspecific musculoskeletal pain for at least 3 months
排除标准
- •New diagnosis within the last 3 months of:
- •Degenerative diseases (e.g., herniated disc, spinal stenosis)
- •Neurological diseases (e.g., neuropathies, multiple sclerosis)
- •Injuries of the spinal column (e.g. due to whiplash, vertebral body fractures, operations)
- •Or severe concurrent diagnosis of:
- •Severe comorbid mental illness (e.g. addiction, severe depression)
- •Severe comorbid physical illness (e.g. cancer diagnosis within the last 5 years, severe preexisting disease of the cardiovascular system, insufficiency of other organs (kidney, liver, etc.), acute febrile infection, other severe neurological diseases such as epilepsy)
- •Pregnancy
- •Current pension application (for work incapacity, occupational disability, reduction in earning capacity, severe disability)
- •Simultaneous participation in other clinical trials
结局指标
主要结局
pain acceptance
时间窗: week 8
Chronic Pain Acceptance Questionnaire, 20 items, range 0-6 with higher scores indicating a better outcome
次要结局
- pain intensity(week 8 and 26)
- psychiatric symptoms(week 8 and 26)
- pain acceptance(week 26)
- health-related quality of life(week 8 and 26)
- pain-associated self-efficacy(week 8 and 26)
- functional impairment(week 8 and 26)
研究者
Holger Cramer
PD Dr. rer. medic. Holger Cramer
Universität Duisburg-Essen