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Completed

NCT Number: NCT04833673

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Anxiety Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Chronic Pain Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Immune System Diseases Kinesiophobia Mental Disorders Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pain, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, None Selected, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PMR: Progressive Muscle Relaxation

Behavioral

tensing and relaxing the body muscles accompanied with deep breathing

BRT:Benson Relaxation Technique

Behavioral

relaxation using mental imagery and mediation

Primary outcomes

  1. Fatigue

    Time frame: 12 weeks

    Fatigue Severity Scale

Secondary outcomes

  1. Chronic Pain

    Time frame: 12 weeks

    VAS

  2. Kinesiophobia

    Time frame: 12 weeks

    Tampa Scale for Kinesophobia

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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