Clinical trial NCT06292312: Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis.
Official title: Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis: A Randomized Controlled, Single-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
craniosacral therapy
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Lokman Hekim Üniversitesi
First posted: 2024-03-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dual parallel group design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dynamic posturography
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Heart rate variability
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Number of participants
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
Secondary outcomes:
measure: Pain level
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Central sensitization
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Fatigue
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Sleep quality
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
measure: Life quality
timeFrame: Change from baseline at 8 weeks treatment program and two months after.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Hilal Aslan, MSc
role: PRINCIPAL_INVESTIGATOR
References: