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

NCT06292312 | Recruiting

• 1 other identifier: 19.12.2023/10-483
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; craniosacral therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Pain level

  Change from baseline at 8 weeks treatment program and two months after.

• Central sensitization

  Change from baseline at 8 weeks treatment program and two months after.

• Fatigue

  Change from baseline at 8 weeks treatment program and two months after.

• Sleep quality

  Change from baseline at 8 weeks treatment program and two months after.

• Life quality

  Change from baseline at 8 weeks treatment program and two months after.

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Other: Craniosacral therapy; Other: Conventional physiotherapy

Control group

ACTIVE COMPARATOR

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

Other: Conventional physiotherapy

Interventions

Craniosacral therapy 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.

Also known as: Conventional physiotherapy

Treatment group

Conventional physiotherapy OTHER

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

Control group; Treatment 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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead
• Lokman Hekim University: collaborator

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hilal Aslan, MSc

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Aslan, MSc

CONTACT

05372565397; hilalaslan@aybu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (outcomes assesor) The evaluation of the patients will be carried out by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: dual parallel group design

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: February 27, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 15, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)