Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis.

Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis: A Randomized Controlled, Single-Blind Study

Although the cause of Multiple Sclerosis (MS), one of the common demyelinating diseases of the central nervous system, has not yet been fully elucidated, autonomic nervous system dysfunction has been suggested in its etiology. Symptoms such as fatigue, problems with bladder, bowel, cardiovascular, sleep, sexual and sweating functions, abnormal sympathetic skin response or decreased heart rate variation support this hypothesis.

In the treatment of many neurological diseases such as Multiple Sclerosis, complementary medicine practices and non-traditional therapies have recently been shown to be effective in addition to conventional practices. One of these practices, craniosacral therapy (CST), uses manual palpation and manipulation of the craniosacral system to influence sensory, motor, cognitive and emotional processes in the nervous system. In addition, it is thought that applying external force to certain bone elements can have a positive effect on various symptoms in patients with MS, based on the knowledge that it can be transmitted within the system.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Craniosacral therapy; Other: Conventional physiotherapy

Detailed Description

In addition to pharmacological treatments, many non-pharmacological treatment modalities such as physiotherapy applications, sleep hygiene training, relaxation techniques, behavioral therapy and cognitive therapies are used in the treatment of MS symptoms. Recently, complementary medicine practices and non-traditional therapies have been shown to be effective in the treatment of many neurological diseases, including MS. Among these methods, craniosacral therapy (CST) has been shown to be effective in the treatment of various neurological conditions affecting the central nervous system. CST is defined as an alternative, massage-like treatment approach using gentle manual force to address somatic dysfunctions of the head and the rest of the body. The interplay of diagnosis and treatment aims to mobilize cranial sutures that abnormally restrict physiological movement.

CST is an approach widely used in adults and children, in different clinical settings and conditions. Based on the knowledge that the application of external force to certain bony elements of this system can be transmitted within the system, it can be considered that craniosacral therapy may have a positive effect on various symptoms in patients with MS. In the light of the results obtained as a result of the study, CST may provide ideas to clinicians and researchers as an alternative and complementary method in the treatment of MS.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilal Aslan, MSc; Phone Number: 05372565397; Email: hilalaslan@aybu.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Recruiting
    • Ankara Yıldırım Beyazıt University
    • Contact: Hilal Aslan; Phone Number: 05372565397; Email: hilalaslan@aybu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 to 65 years old
• Definitive diagnosis of MS by a neurologist
• EDSS score between 1-5.5
• Not receiving active physical therapy services
• Volunteering.

Exclusion Criteria:

• Having a neurological disease other than MS
• Attacks in the last three months
• Corticosteraoid use
• History of surgery on the spine
• Central and peripheral nervous system disease
• Pregnancy
• Oncological diseases
• Severe comorbid somatic and psychiatric disorders
• Receiving invasive/manipulative treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Patients in this grop are the group to which craniosacral therapy and convensional physiotherapy will be applied.	Other: Craniosacral therapy; Craniosacral therapy is defined as an alternative, massage-like treatment approach using gentle manual force to address somatic dysfunctions of the head and the rest of the body.; Other Names: Conventional physiotherapy; Other: Conventional physiotherapy; Range of motion, stretching, resistance exercises. Spasticity inhibition Balance and coordination exercises Walking training Stabilization exercises Breathing exercises
Active Comparator: Control group; Patients in this group are the group to which conventional physiotherapy will be applied.	Other: Conventional physiotherapy; Range of motion, stretching, resistance exercises. Spasticity inhibition Balance and coordination exercises Walking training Stabilization exercises Breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic posturography	Dynamic posturography is a device that converts the balance of the individual under changing floor, environment and stimulus conditions into computerized data with receivers on the floor.	Change from baseline at 8 weeks treatment program and two months after.
Heart rate variability	Heart rate variability is a tool that allows the investigation of cardiovascular autonomic function through the measurement of variations in RR intervals and provides valuable information about the control of autonomic nervous system.	Change from baseline at 8 weeks treatment program and two months after.
Number of participants	A total of 32 MS patients, 16 in both groups, will be included in the study.	Change from baseline at 8 weeks treatment program and two months after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Visual analog scale will be used to examine pain levels of participants. Individuals are presented with a line numbered evenly from 1 to 10 and asked to mark the point corresponding to their pain intensity. A higher score indicates that severity of pain increasing.	Change from baseline at 8 weeks treatment program and two months after.
Central sensitization	The Central Sensitization Scale (CSS) will be used. The CSS was developed as a screening tool to better assess symptoms thought to be associated with CS, categorize syndromes, define disease severity, measure sensitivity, and assist physicians and clinicians in treatment planning by minimizing or, if possible, avoiding unnecessary diagnostic and treatment procedures. Part A of the SSI includes all CS symptoms and is the part that will help clinicians to recognize the CS patient. According to the scale, those with a score above 40 are considered to have developed CS.	Change from baseline at 8 weeks treatment program and two months after.
Fatigue	Fatigue Severity Scale will be applied. Each item in the self-administered 9-question scale, which reflects the situation of the individuals in the last week, consists of "1" Strongly disagree, "7" It consists of a score between "1-7" corresponding to the statement "I agree". As a result of dividing the total score obtained by the number of questions, ">6.1" corresponds to chronic fatigue syndrome and "<2.8" to no fatigue. The lower the total score, the less fatigue is interpreted	Change from baseline at 8 weeks treatment program and two months after.
Sleep quality	Pittsburgh Sleep Quality Index (PSQI) will be used. The PSQI is a self-report scale that assesses sleep quality and sleep disturbance over a one-month period. The PDQI has 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction. Some of the components are indicated by a single item, while others are obtained by grouping several items. Each item is evaluated on a 0-3 point scale and the sum of the 7 component scores constitutes the total PDQI score. The total score has a value between 0-21, with a high total score indicating poor sleep quality.	Change from baseline at 8 weeks treatment program and two months after.
Life quality	Multiple Sclerosis Quality of Life Scale (MSQoL-54) scale will be used. It was created by Vickrey et al. (1995) by adding 18 items specific to MS to the SF-36 quality of life scale used in many diseases. The MSQoL was created by adding 18 items to the items in the SF-36 related to general health perception (5 items), energy/fatigue (4 items), social function (2 items), emotional flexibility (5 items), limitations due to emotional problems (3 items), limitations due to physical problems (4 items), physical function (10 items), pain (2 items) and change in health. The 2 main groups of the scale score between 0-100, with higher scores indicating higher quality of life.	Change from baseline at 8 weeks treatment program and two months after.

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Collaborators: Lokman Hekim Üniversitesi
• Investigators: Principal Investigator: Hilal Aslan, MSc, Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: multiple sclerosis; craniosacral therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 19.12.2023/10-483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Indivudual participant data will be available to the responsible researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No