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

NCT ID: NCT06292312

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-05-15

Brief Summary

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.

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

Patients in this grop are the group to which craniosacral therapy and convensional physiotherapy will be applied.

Group Type: EXPERIMENTAL

Craniosacral therapy

Intervention Type: OTHER

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.

Conventional physiotherapy

Intervention Type: OTHER

Range of motion, stretching, resistance exercises. Spasticity inhibition Balance and coordination exercises Walking training Stabilization exercises Breathing exercises

Control group

Patients in this group are the group to which conventional physiotherapy will be applied.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

Range of motion, stretching, resistance exercises. Spasticity inhibition Balance and coordination exercises Walking training Stabilization exercises Breathing exercises

Interventions

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.

Intervention Type: OTHER

Conventional physiotherapy

Range of motion, stretching, resistance exercises. Spasticity inhibition Balance and coordination exercises Walking training Stabilization exercises Breathing exercises

Intervention Type: OTHER

Other Intervention Names

Conventional physiotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: collaborator

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hilal Aslan, MSc

Role: PRINCIPAL_INVESTIGATOR

Ankara Yildirim Beyazıt University

Locations

Ankara Yıldırım Beyazıt University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hilal Aslan, MSc

Role: CONTACT

hilalaslan@aybu.edu.tr

05372565397

Facility Contacts

Hilal Aslan

Role: primary

hilalaslan@aybu.edu.tr

05372565397

Other Identifiers

19.12.2023/10-483

Identifier Type: -

Identifier Source: org_study_id