The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial

Pain, Chronic Clinical Trial

Official title:

The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833673
• Other study ID #: 333
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: June 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over the age of 18
• having relapsing-remitting MS type and not had an attack during the study
• not receiving any other complementary and integrative therapy during the research,
• with an Expanded Disability Status Scale score of 5.5 and below,
• volunteer to participate in study

Exclusion Criteria:

• having physical or mental health problems that can interfere with communication
• having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis, rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses
• not having undergone any surgical operation in the last 3 months

Related Conditions & MeSH terms

• Chronic Pain
• Fatigue
• Fatigue Syndrome, Chronic
• Kinesiophobia
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Pain, Chronic
• Sclerosis

Intervention

Behavioral:
• PMR: Progressive Muscle Relaxation
tensing and relaxing the body muscles accompanied with deep breathing
• BRT:Benson Relaxation Technique
relaxation using mental imagery and mediation

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Fatigue Severity Scale	12 weeks
Secondary	Chronic Pain	VAS	12 weeks
Secondary	Kinesiophobia	Tampa Scale for Kinesophobia	12 weeks