Acupressure in MS Patients

NCT06755463 | Not Yet Recruiting

• 1 other identifier: AIBU-HSF-SDEMIR-05
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; pain; fatigue; cognition; quality of life; depression

Outcome Measures

Primary Outcomes (3)

• Beta-Endorphin levels

  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.

  from baseline to two months

• Hypocretin levels

  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.

  from baseline to two months

• Cognition

  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.

  from baseline to two months

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive acupressure therapy for 8 weeks, with twice-weekly sessions between 8:00 AM and 10:00 AM. A certified practitioner will train them on acupressure principles, including target points, pressure techniques, frequency, and duration. Practical demonstrations will ensure correct technique application. Training groups of up to 10 participants will learn the method in a comfortable setting. The protocol targets beta-endorphin and hypocretin levels, cognition, and patient-reported outcomes (pain, fatigue, depression, and quality of life). 6 acupressure points (LI4, SP6, GV20, HT7, EX-HN3, and LV3) will be used, totaling 12 symmetrical points. Pressure will be applied for 2 minutes per point using 3-5 kg force in rhythmic movements, totaling 24 minutes. Participants will practice under supervision, receive a diary to track home practice, and be given a visual guide for proper technique.

Other: Self-acupressure education

Control group

NO INTERVENTION

Participants in the control group will not receive any acupressure therapy during the study period. They will continue to receive routine clinical care as recommended by their physicians. After the study concludes, acupressure points and techniques will be demonstrated and taught to participants in this group. They will also receive the same visual guide/brochure provided to the intervention group, explaining each acupressure point and application method in detail.

Interventions

Self-acupressure education OTHER

Participants will undergo acupressure therapy for 8 weeks, with twice-weekly sessions between 8:00 AM and 10:00 AM. A certified practitioner will train participants on target points, pressure techniques, frequency, and duration. Practical demonstrations will ensure correct application. Groups of up to 10 participants will be trained in a comfortable setting and practice techniques under supervision until proficient. The treatment protocol, based on literature, focuses on beta-endorphin and hypocretin levels, cognition, and patient-reported outcomes (pain, fatigue, depression, and quality of life). Participants will apply 3-5 kg pressure for 2 minutes per point at 12 symmetrical points (LI4, SP6, GV20, HT7, EX-HN3, LV3) using rhythmic movements, totaling 24 minutes. They will receive a diary to track home practices and a visual guide explaining each point's location and steps for application.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Pain; Fatigue; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Seyma Demir Erbas, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyma Demir Erbas, PhD

CONTACT

+90(546)4715674; seymademir@ibu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed as a single-blind, randomized, controlled, and experimental trial. It involves two parallel groups: an intervention group and a control group. Participants in the intervention group will receive acupressure therapy for 8 weeks, applied twice per week, following structured training provided by a certified practitioner. The therapy targets specific acupressure points associated with pain relief, fatigue reduction, cognitive improvement, and emotional regulation. Participants in the control group will receive routine clinical care without any acupressure intervention during the study period. However, they will be trained in acupressure techniques and provided educational materials at the end of the study.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: March 18, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: March 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share