The Effect of Acupressure on Beta-Endorphin, Hypocretin, Cognition, and Patient-Reported Outcome Measures in Multiple Sclerosis Patients (APEX-MS Trial): a Single-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 82
- 主要终点
- Beta-Endorphin levels
研究概览
简要总结
This study aims to evaluate the effects of acupressure therapy on patients with Multiple Sclerosis (MS). MS is a chronic autoimmune disease affecting the central nervous system, characterized by inflammation, demyelination, and nerve damage. Patients often experience symptoms such as fatigue, muscle weakness, pain, depression, anxiety, and cognitive impairment, which lower their quality of life and make daily activities challenging. In addition to conventional treatments, complementary therapies can help alleviate these symptoms. Acupressure is a non-invasive technique that involves applying pressure to specific points on the body to regulate energy flow, without using needles.
This research investigates the effects of acupressure on beta-endorphin and hypocretin levels, cognitive functions, and patient-reported symptoms in MS patients. Beta-endorphin is known as a natural pain reliever, while hypocretin plays a role in regulating sleep-wake cycles and energy levels. The study hypothesizes that acupressure can increase the levels of these biochemical substances, improving pain, fatigue, and cognitive functions.
This single-blind, randomized controlled trial will include 82 MS patients. Participants will be divided into two groups: the intervention group (receiving acupressure therapy) and the control group (receiving routine care). The acupressure intervention will be performed twice a week for eight weeks. Participants in the intervention group will learn acupressure techniques and apply them as part of the treatment, while those in the control group will receive acupressure training after the study ends.
Throughout the study, beta-endorphin and hypocretin levels will be measured via blood tests, and cognition, pain, fatigue, depression, and quality of life will be assessed using validated scales. Participants will also report their experiences during the treatment, and the data collected will be analyzed through comparative evaluations.
This research aims to comprehensively analyze the effects of acupressure on MS patients and provide scientific evidence regarding the effectiveness of complementary therapies. The findings may offer an alternative method to improve quality of life and alleviate symptoms for MS patients. Acupressure's simplicity, affordability, and ease of application make it a more accessible and sustainable option. The study will be conducted in compliance with ethical standards, prioritizing participant safety.
详细描述
Background Multiple Sclerosis (MS) is a chronic autoimmune and neurodegenerative disease affecting the central nervous system (CNS). It is characterized by inflammation, demyelination, gliosis (scar formation), and axonal damage. These pathological changes lead to impairments in motor and cognitive functions, sensory perception, vision, and balance. The unpredictable progression of MS contributes to physical disability and psychological distress, significantly reducing patients' quality of life.
Current treatments primarily focus on disease-modifying therapies (DMTs) to slow disease progression and symptomatic management strategies to address pain, fatigue, depression, and cognitive impairments. However, conventional approaches often fail to fully alleviate symptoms, leading patients to seek complementary and alternative therapies. Acupressure has emerged as a promising complementary method due to its non-invasive, low-cost, and easy-to-apply nature.
Acupressure is based on Traditional Chinese Medicine principles and involves applying pressure to specific points on the body. It aims to balance energy flow and promote physiological and psychological well-being. Studies have demonstrated its effectiveness in reducing pain, fatigue, and stress and improving sleep quality and cognitive function. However, evidence on its impact on neuropeptides such as beta-endorphin and hypocretin in MS patients remains limited.
Beta-endorphin is an endogenous opioid peptide known for its analgesic properties, stress modulation, and role in emotional regulation. Hypocretin (also called orexin) regulates arousal, wakefulness, and energy balance. Dysregulation of these neuropeptides has been implicated in MS-related symptoms, including fatigue, pain, and cognitive decline. This study aims to explore whether acupressure can modulate these biomarkers and improve clinical outcomes in MS patients.
The APEX-MS study (Trial of Acupressure and Patient Experience in Multiple Sclerosis) aims to investigate the effects of acupressure on beta-endorphin levels, hypocretin levels, cognition, and patient-reported outcome measures (PROMs) in individuals with MS.
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
- Single (Outcomes Assessor)
盲法说明
In this clinical trial, the outcome assessors are masked to the group assignments to minimize evaluation bias. Participants are not masked, as those in the intervention group will receive acupressure therapy, while the control group will receive routine care without acupressure. Data analysts will receive de-identified data for analysis to further reduce bias during statistical evaluation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of an MS diagnosis confirmed by a neurologist based on the McDonald criteria.
- •Having the RRMS subtype.
- •Diagnosed with MS for at least one year.
- •Individuals aged 18-65 years.
- •An EDSS score between 0 and 5, indicating mild to moderate disability.
- •No use of steroid therapy or discontinuation of steroid therapy at least 3 months prior to participation.
- •No MS relapse within the last 3 months.
- •No prior use of acupressure or other complementary therapies.
- •Sufficient language proficiency to understand the study and complete assessments.
排除标准
- •Presence of any open wounds or deformities at the application site.
- •Presence of neurodegenerative or neuropsychiatric disorders such as - Parkinson's or Alzheimer's, which may potentially confound the study results.
- •Pregnant or breastfeeding women, due to hormonal changes that may affect outcomes.
- •Presence of severe cardiovascular, pulmonary, hepatic, renal, or psychiatric diseases.
结局指标
主要结局
Beta-Endorphin levels
时间窗: from baseline to two months
Beta-endorphin levels will be measured using blood samples collected during routine clinical follow-ups, eliminating the need for additional invasive procedures. These biomarkers will be analyzed in an external laboratory using ELISA kits, and the results will be recorded and used for statistical analysis.
Hypocretin levels
时间窗: from baseline to two months
Hypocretin levels will be measured using blood samples collected during routine clinical follow-ups, eliminating the need for additional invasive procedures. These biomarkers will be analyzed in an external laboratory using ELISA kits, and the results will be recorded and used for statistical analysis.
Cognition
时间窗: from baseline to two months
Cognition in this study will be assessed using BICAMS, which includes SDMT for processing speed, CVLT-II for verbal memory, and BVMT-R for visual memory. These tests are validated tools for evaluating cognitive impairment in MS patients. Higher scores indicate better cognitive performance, and results will be analyzed to determine the impact of the intervention.
次要结局
- Pain measurement(from baseline to two months)
- Fatigue(from baseline to two months)
- Depression(from baseline to two months)
- Quality of life measurement(from baseline to two months)
研究者
Seyma Demir
Assistant Professor
Abant Izzet Baysal University