FibromyalgiaNCT05695274
Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status
A study testing Progressive muscle relaxation exercise in people with Fibromyalgia, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Progressive muscle relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being older than 18 years of age
- Having been diagnosed with fibromiyalgia for at least 6 months ago.
- Having no mental disability
Who cannot join
- Individuals receiving another complementary and integrative treatment
- Individuals who have done progressive muscle relaxation exercise before.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Health Science Faculty
Aksaray, 68100
Cemile KÜTMEÇ YILMAZ
Merkez, Aksaray, 68100
About this study
Official title: 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.
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.
- Conditions
- Fibromyalgia
- Being tested
- Progressive muscle relaxation exercise
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | To examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients. Receives: Behavioral: Progressive muscle relaxation exercise |
| Control group | No intervention | Control group; routine care and treatment will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive muscle relaxation exercise changes pain
Visual Pain Scale
Measured: 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
Tampa Scale for Kinesiophobia
Measured: 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
Revised Fibromyalgia Impact Questionnaire
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start10 Nov 2022
- Primary completion30 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
- Investigators
- CEMİLE KÜTMEÇ YILMAZ, Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695274
- Sponsor's protocol ID
- 2022/14-05
- Status last verified
- Apr 2024
- First submitted
- 5 Jan 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakoyun A, Kutmec Yilmaz C, Sayin Kasar K. Are Progressive Muscle Relaxation Exercises Effective on Pain, Kinesiophobia, and Functional Status in Fibromyalgia Patients? A Randomized Controlled Trial. Res Nurs Health. 2026 Feb;49(1):9-18. doi: 10.1002/nur.70029. Epub 2025 Nov 14.
PubMed 41235733
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT05695274
- Acronym / sponsor ID
- 2022/14-05
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Progressive muscle relaxation exerciseTo examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients. |
| Control group | No intervention | –Control group; routine care and treatment will be applied. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being older than 18 years of age
- Having been diagnosed with fibromiyalgia for at least 6 months ago.
- Having no mental disability
Key exclusion criteria (2 listed)
- Individuals receiving another complementary and integrative treatment
- Individuals who have done progressive muscle relaxation exercise before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxation exerciseExperimental 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. | Behavioural | Experimental group |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 41235733Karakoyun A, Kutmec Yilmaz C, Sayin Kasar K. Are Progressive Muscle Relaxation Exercises Effective on Pain, Kinesiophobia, and Functional Status in Fibromyalgia Patients? A Randomized Controlled Trial. Res Nurs Health. 2026 Feb;49(1):9-18. doi: 10.1002/nur.70029. Epub 2025 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CEMİLE KÜTMEÇ YILMAZ principal investigator
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation exercise in people with Fibromyalgia, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.