Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status

April 16, 2024 updated by: Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital

Effect of Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status in Fibromyalgia Patients

Relaxation techniques are a non-pharmacological therapy option applied to alleviate the symptoms of many different chronic diseases. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. This study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia (FM), which is a chronic pain disorder, is a difficult disease to treat, and it is stated that a multidisciplinary approach is required in its treatment rather than a single treatment method. Approaches that consider optimal symptom management and functional status in treatment, include non-pharmacological methods in addition to pharmacological treatment, and include psychosocial and behavioral methods are recommended. Non-pharmacological methods that have proven their effectiveness in FM treatment include aerobic exercise, patient education, cognitive therapies, balneotherapy, and physical therapy agents. One of the methods that can be applied in patients with FM is progressive muscle relaxation (PMR) exercises. PMR is an easy, low-cost, and side-effect-free relaxation technique. PMR helps individuals feel calmer and more relaxed through sequential muscle tension and relaxation. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. Therefore, this study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aksaray, Turkey, 68100
        • Aksaray University Health Science Faculty
    • Aksaray
      • Merkez, Aksaray, Turkey, 68100
        • Cemile KÜTMEÇ YILMAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being older than 18 years of age
  • Having been diagnosed with fibromiyalgia for at least 6 months ago.
  • Having no mental disability

Exclusion Criteria:

  • Individuals receiving another complementary and integrative treatment
  • Individuals who have done progressive muscle relaxation exercise before.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
To examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.
Behavioral: Progressive muscle relaxation exercise
Experimental group Fibromyalgia patients will be provided with progressive relaxation exercises twice a week. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation.
No Intervention: Control group
Control group; routine care and treatment will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive muscle relaxation exercise changes pain
Time Frame: The pain scores of the patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week using the visual pain scale. The pain score is min 1 - max 10.
Visual Pain Scale
The pain scores of the patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week using the visual pain scale. The pain score is min 1 - max 10.
Progressive muscle relaxation exercise changes kinesiophobia
Time Frame: The Kinesiophobia scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A total of 17-68 points are obtained from the scale.
Tampa Scale for Kinesiophobia
The Kinesiophobia scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A total of 17-68 points are obtained from the scale.
Progressive muscle relaxation exercise changes functional status
Time Frame: The functional status scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A high score indicates increased disability due to FM.
Revised Fibromyalgia Impact Questionnaire
The functional status scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A high score indicates increased disability due to FM.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aksaray University Training and Research Hospital

Investigators

  • Principal Investigator: CEMİLE KÜTMEÇ YILMAZ, Aksaray University, Faculty of Health Science, Nursing Department, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/14-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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