DysmenorrheaNCT02663050
The Effect of Kinesio Taping Application for Dysmenorrhea
A study testing Kinesio taping and NSAID's in people with Dysmenorrhea, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Kinesio taping and NSAID's
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Dysmenorrhea
Who cannot join
- pregnancy
- surgical abdominal emergency
- metabolic or inflammatory illnesses or cardiovascular diseases,
- endocrine disorders such as diabetes, thyroid disorders, androgen excess (hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumor),
- smokers
- using pharmaceutical agents such as anti-inflammatory agents that could possibly impact on endocrine and liver enzymes
- musculoskeletal pain
- inguinal hernia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Kinesio Taping Application for Dysmenorrhea: A Randomized Controlled Clinical Trial
Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which can be used in outpatient practice without systemic side effects.
Read the detailed description
Dysmenorrhea is a kind of visceral pain that result of peritoneal irritation. It is so common in gynecological outpatient practice. Most of treatment is based pharmacological treatments as NSAIDs, oral contraceptives with many side effects. Kinesio taping is widely used for musculoskeletal parenchymal pain like sports related injuries. As in other complementary treatment methods like acupuncture and acupressure; pain carrying unmyelinated thin pain fibers are blocked by touch sensation carrying myelinated thick fibers which is stimulated by acupressure(gate control theory by Melzack), kinesio taping blocks the pain fibers that comes from same spinal level. So it can be used easily and instantly for dismenore
- Conditions
- Dysmenorrhea
- Being tested
- Kinesio taping, NSAID's
- Keywords
- Dysmenorrhea, kinesio tape
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Patients will be taped for four days , ıt will start at the begining of the Dysmenorrhea
NSAID'sDrug
Also called Diclophenac Potassium
twice a daily
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping group | Experimental | only Kinesio taping treatment group Receives: Other: Kinesio taping |
| NSAID treatment group | Active comparator | only NSAIDs taking group Receives: Drug: NSAID's |
| Combination treatment group | Active comparator | NSAIDs plus Kinesio taping group Receives: Other: Kinesio taping; Drug: NSAID's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
At the begining of the Dysmenorrhea before taping we will measure the VAS level (pretreatment)and 4 days after taping we will measure the second VAS level (after treatment)
Measured: 0- 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozturk, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Mustafa Öztürk, M.D., Principal investigator, Etimesgut Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663050
- Sponsor's protocol ID
- Mustafa
- Status last verified
- Feb 2016
- First submitted
- 19 Jan 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will share the data monthly
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio Taping Application for Dysmenorrhea: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02663050
- Acronym / sponsor ID
- Mustafa
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, kinesio tape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which can be used in outpatient practice without systemic side effects.
Detailed description
Dysmenorrhea is a kind of visceral pain that result of peritoneal irritation. It is so common in gynecological outpatient practice. Most of treatment is based pharmacological treatments as NSAIDs, oral contraceptives with many side effects. Kinesio taping is widely used for musculoskeletal parenchymal pain like sports related injuries. As in other complementary treatment methods like acupuncture and acupressure; pain carrying unmyelinated thin pain fibers are blocked by touch sensation carrying myelinated thick fibers which is stimulated by acupressure(gate control theory by Melzack), kinesio taping blocks the pain fibers that comes from same spinal level. So it can be used easily and instantly for dismenore
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping group | Experimental | Other: Kinesio tapingonly Kinesio taping treatment group |
| NSAID treatment group | Active comparator | Drug: NSAID'sonly NSAIDs taking group |
| Combination treatment group | Active comparator | Other: Kinesio taping, Drug: NSAID'sNSAIDs plus Kinesio taping group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Dysmenorrhea
Key exclusion criteria (8 listed)
- pregnancy
- surgical abdominal emergency
- metabolic or inflammatory illnesses or cardiovascular diseases,
- endocrine disorders such as diabetes, thyroid disorders, androgen excess (hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumor),
- smokers
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 |
|---|---|---|
| Kinesio tapingPatients will be taped for four days , ıt will start at the begining of the Dysmenorrhea | Other | Combination treatment group, Kinesio taping group |
| NSAID'sAlso: Diclophenac Potassiumtwice a daily | Drug | Combination treatment group, NSAID treatment group |
Primary outcome
Visual analog scale
Time frame: 0- 4th day
At the begining of the Dysmenorrhea before taping we will measure the VAS level (pretreatment)and 4 days after taping we will measure the second VAS level (after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Individual participant dataSharing planned: Yes. We will share the data monthly
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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.
Mustafa Öztürk, M.D. principal investigator
Etimesgut Military Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and NSAID's in people with Dysmenorrhea, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Öztürk, M.D. (+905358333956, drmozturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 0- 4th day). 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 29 Feb 2016.