FibromyalgiaNCT06171022
The Effect of Cherry Seed Pillow on Fibromyalgia
A study testing Cherry seed pillow in people with Fibromyalgia, run by Hasan Gerçek at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cherry seed pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2023to 10 Feb 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Over 18 years of age
- Diagnosis of Fibromyalgia according to ACR classification criteria
- Neuromuscular system examination is normal
- Pain (vas-visual anologous scale) level of at least 5 points
- No communication problems
- Willingness to participate in the practice of using cherry seed cushion
- To be capable of answering the data collection tools to be used in the research
- Not having made hot, cold etc. applications at home
Who cannot join
- -No diagnosis of Fibromyalgia according to ACR classification criteria
- Normal examination of the neuromuscular system
- Pain (vas-visual anologous scale) level between 0-5
- Communication problems
- Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
- Having a musculoskeletal disorder other than fibromyalgia
Show all 9Show fewer
- Pregnant or lactating
- To be capable of answering the data collection tools to be used in the research
- Having made hot, cold etc. applications at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cherry Seed Pillow on Pain and Quality of Life in Patients With Fibromyalgia
In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.
- Conditions
- Fibromyalgia
- Being tested
- Cherry seed pillow, Control
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry seed pillowOther
4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of heated cherry seed pillow will be applied to the participant's back area.
ControlOther
4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of hotpack will be applied to the participant's back area.
| Study group | Role | What they receive |
|---|---|---|
| Cherry seed pillow | Experimental | 4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a heated cherry seed pillow will be applied. Receives: Other: Cherry seed pillow |
| Control | Active comparator | 4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a hot-pack will be applied. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain at 4 weeks
he rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change from baseline in function at 4 weeks
The Fibromyalgia Impact Questionnaire will be used to assess the functioning of the participants. The questionnaire consists of 20 questions. As the score increases, the function decreases.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start6 Dec 2023
- Primary completion6 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Gerçek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hasan Gerçek, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171022
- Sponsor's protocol ID
- KaratatUH10
- Status last verified
- Feb 2024
- First submitted
- 6 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cherry Seed Pillow on Pain and Quality of Life in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06171022
- Acronym / sponsor ID
- KaratatUH10
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hasan GerçekUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 14 Dec 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.
In this study, the effects of 4-week Cherry seed pillow application on pain and quality of life in individuals diagnosed with fibromyalgia will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cherry seed pillow | Experimental | Other: Cherry seed pillow4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a heated cherry seed pillow will be applied. |
| Control | Active comparator | Other: Control4 Weeks, 5 days a week, 20 minutes, in addition to the physiotherapy application of the routine, a hot-pack will be applied. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Over 18 years of age
- Diagnosis of Fibromyalgia according to ACR classification criteria
- Neuromuscular system examination is normal
- Pain (vas-visual anologous scale) level of at least 5 points
- No communication problems
Key exclusion criteria (9 listed)
- -No diagnosis of Fibromyalgia according to ACR classification criteria
- Normal examination of the neuromuscular system
- Pain (vas-visual anologous scale) level between 0-5
- Communication problems
- Failure to accept the practice of using cherry seed cushion and failure to finish the implementation process
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 |
|---|---|---|
| Cherry seed pillow4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of heated cherry seed pillow will be applied to the participant's back area. | Other | Cherry seed pillow |
| Control4 Weeks, 5 days a week, in addition to the routine physiotherapy application, 20 minutes of hotpack will be applied to the participant's back area. | Other | Control |
Primary outcome
Change from baseline in pain at 4 weeks
Time frame: Baseline and 4 weeks
he rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.
1 secondary outcome
Change from baseline in function at 4 weeks
Time frame: Baseline and 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 13 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cherry seed pillow in people with Fibromyalgia, run by Hasan Gerçek 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 8 inclusion and 9 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 13 Feb 2024. 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?
Change from baseline in pain at 4 weeks (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.