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CompletedNCT05695274Updated Apr 17, 2024

Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status

An interventional study of Progressive muscle relaxation exercise in Fibromyalgia, sponsored by Aksaray University Training and Research Hospital. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Aksaray University Training and Research Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

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In context

Fibromyalgia

1,338 studies on the registry are indexed under Fibromyalgia; 268 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 1,037 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Aksaray University Training and Research Hospital is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    Control group; routine care and treatment will be applied.

Interventions

  • BehavioralProgressive 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.

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What researchers measure

Primary outcomes

  1. Progressive muscle relaxation exercise changes pain

    Visual Pain Scale

    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.

  2. Progressive muscle relaxation exercise changes kinesiophobia

    Tampa Scale for 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.

  3. Progressive muscle relaxation exercise changes functional status

    Revised Fibromyalgia Impact Questionnaire

    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.

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Study locations

2 sites
  • Cemile KÜTMEÇ YILMAZ
    Merkez, Aksaray 68100, Turkey
  • Aksaray University Health Science Faculty
    Aksaray, 68100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05695274
Lead sponsor
Aksaray University Training and Research Hospital
Responsible party
Cemile KÜTMEÇ YILMAZ (Principal Investigator, Aksaray University Training and Research Hospital) — Principal investigator
First posted
Jan 25, 2023
Start date
Nov 10, 2022
Primary completion
Jun 30, 2023
Completion
Nov 30, 2023
Last update
Apr 17, 2024

Study contacts

CEMİLE KÜTMEÇ YILMAZ
principal investigator · Aksaray University, Faculty of Health Science, Nursing Department, Turkey

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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