FibromyalgiaNCT05897931
Effects of Two Different Applications in Fibromyalgia
A study testing Connective tissue massage and Kinesio Tape Application in people with Fibromyalgia, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Connective tissue massage and Kinesio Tape Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 7 Jul 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with fibromyalgia.
- Be in the age range of 20 - 55 years.
- To be a volunteer participant in the research.
- Being able to communicate comfortably.
- To be able to act independently.
Who cannot join
- Having had a surgical operation within the last year.
- Presence of significant infection.
- Being diagnosed with cancer.
- Being pregnant or breastfeeding.
- Being addicted to drugs or alcohol.
- Having a cognitive problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia
The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life.
- Conditions
- Fibromyalgia
- Being tested
- Connective tissue massage, Kinesio Tape Application
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue massageOther
Connective Tissue Massage will be applied by starting from the lumbosacral region, continuing from the lower thoracic region, and finishing by applying it to the scapular region, interscapular region, and cervico-occipital region.
Kinesio Tape ApplicationOther
Taping will be applied to the levator scapula and upper trapezius muscles in a "Y" shape, with 25% tension and while the participants were in an upright position. Again in the same position, this time the "C" shaped taping technique will be adhered with 50% tension from the middle fibers of the trapezium to the last rib.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage | Experimental | Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Then Connective Tissue Massage will be applied. Receives: Other: Connective tissue massage |
| Kinesio Tape Application | Experimental | Participants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Kinesio tape application will be applied 2 days a week for 4 weeks. Receives: Other: Kinesio Tape Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale (VAS) will be used to assess pain severity. In the assessment, the patient is asked to mark pain intensity on a 10-centimeter line that no pain is 0, and the most severe pain is 10.
Measured: 4 weeks
Secondary outcomes (4)
Fibromyalgia Impact Questionnaire
The questionnaire assesses the functional status of patients with fibromyalgia. The scale consists of 20 questions that measure physical function, well-being, difficulty in doing work, not being able to go to work, fatigue, stiffness, morning fatigue, pain, anxiety, and depression separately. Low scores indicate improvement or less effect in patients.
Measured: 4 weeks
McGill Pain Questionnaire
The quality of the pain felt by the patients will be evaluated with the Short Form McGill Pain Questionnaire. The level of severity felt by the patient is evaluated with a number scale (0=no, 1=mild, 2=moderate, 3=severe), and higher scores show severe pain intensity.
Measured: 4 weeks
Beck's Depression Inventory
The Beck's Depression Inventory (BDI) is a 21-item self-assessment scale that evaluates the patients' perceived depressive symptoms quantitatively and measures the symptoms of depression. The higher scores indicate the severity of the patient's depression. It has been suggested that those who score 17 and above on the BDI may constitute an at-risk group.
Measured: 4 weeks
Short Form-36 Quality of Life Scale
The scale assesses the quality of life. The scale consists of 36 items evaluated in 8 separate subscales. The score from each subscale is between 0-100, and a higher score indicates better quality of life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2023
- Study completion7 Jul 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.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
- Investigators
- Rasmi Muammer, PhD, Study chair, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897931
- Sponsor's protocol ID
- Fibromyalgia
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turksen G, Kisa EP, Kaya BK, Muammer K, Muammer R. Effects of connective tissue massage and kinesiotaping in patients with fibromyalgia. J Bodyw Mov Ther. 2024 Oct;40:1020-1026. doi: 10.1016/j.jbmt.2024.07.009. Epub 2024 Jul 11.
PubMed 39593407
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05897931
- Acronym / sponsor ID
- Fibromyalgia
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 9 Jun 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.
The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage | Experimental | Other: Connective tissue massageParticipants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Then Connective Tissue Massage will be applied. |
| Kinesio Tape Application | Experimental | Other: Kinesio Tape ApplicationParticipants will receive TENS and infrared treatment for 25 minutes, 5 days a week. Kinesio tape application will be applied 2 days a week for 4 weeks. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being diagnosed with fibromyalgia.
- Be in the age range of 20 - 55 years.
- To be a volunteer participant in the research.
- Being able to communicate comfortably.
- To be able to act independently.
Key exclusion criteria (6 listed)
- Having had a surgical operation within the last year.
- Presence of significant infection.
- Being diagnosed with cancer.
- Being pregnant or breastfeeding.
- Being addicted to drugs or alcohol.
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 |
|---|---|---|
| Connective tissue massageConnective Tissue Massage will be applied by starting from the lumbosacral region, continuing from the lower thoracic region, and finishing by applying it to the scapular region, interscapular region, and cervico-occipital region. | Other | Connective tissue massage |
| Kinesio Tape ApplicationTaping will be applied to the levator scapula and upper trapezius muscles in a "Y" shape, with 25% tension and while the participants were in an upright position. Again in the same position, this time the "C" shaped taping technique will be adhered with 50% tension from the middle fibers of the trapezium to the last rib. | Other | Kinesio Tape Application |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
Visual Analogue Scale (VAS) will be used to assess pain severity. In the assessment, the patient is asked to mark pain intensity on a 10-centimeter line that no pain is 0, and the most severe pain is 10.
4 secondary outcomes
Fibromyalgia Impact Questionnaire
Time frame: 4 weeks
McGill Pain Questionnaire
Time frame: 4 weeks
Beck's Depression Inventory
Time frame: 4 weeks
Short Form-36 Quality of Life Scale
Time frame: 4 weeks
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 11 Jul 2023.
- Derived from this study: PubMed 39593407Turksen G, Kisa EP, Kaya BK, Muammer K, Muammer R. Effects of connective tissue massage and kinesiotaping in patients with fibromyalgia. J Bodyw Mov Ther. 2024 Oct;40:1020-1026. doi: 10.1016/j.jbmt.2024.07.009. Epub 2024 Jul 11.
- 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.
Rasmi Muammer, PhD study chair
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue massage and Kinesio Tape Application in people with Fibromyalgia, run by Biruni University at 1 site 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 5 inclusion and 6 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Visual Analogue Scale (time frame: 4 weeks). 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 NCT05897931, 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 11 Jul 2023.