Primary DysmenorrheaNCT03290066
Effectiveness of Kinesiotaping in Primary Dysmenorrhea
A study testing kinesiotape in people with Primary Dysmenorrhea, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- kinesiotape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 30 Apr 2018
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women presenting menstrual pain, 4 or more in VAS.
- Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
- Not have been diagnosed with secondary dysmenorrhea
- Regular menstrual cycles (cycle typical range of 21 to 35 days)
- Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
- Nulliparous
- Ability to complete questionnaires in Spanish.
Who cannot join
- Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
- Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
- Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
- Women who suffer from diseases diagnosed added
- Women to which it has undergone a surgical procedure for the treatment
- Provide skin lesions in the abdominal wall or in lumbar region
- Use or abuse of drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.
Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common cause of absenteeism and reduced quality of life in women.
Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms.
First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some women have contraindications to these treatments. Consequently, it´s necessary to study alternative treatments to drug treatments. Alternative treatments like heat, massage therapy, acupuncture also are used.
The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s. It is water resistant and retains its properties up to 5 days.
It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.
- Conditions
- Primary Dysmenorrhea
- Being tested
- kinesiotape, Usual care
- Keywords
- Primary Dysmenorrhea, Kinesio Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapeDevice
For the Kinesio taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back.
Usual careOther
Also called self-care
Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Active comparator | Kinesiotape will be applied as a self-treatment. All participants will be instructed in an indvidual session and will receive a tutorial video to remember the kinesiotaping procedure. 3 band of a special and hypoallergenic tape (Kinematix Tex) will be attached to the abdominal (2 strips) and lower back (1 strip).
Patients will be taped for four days , ıt will start at the beginning of the menstruation. Receives: Device: kinesiotape |
| Usual care | Active comparator | Participants will use the usual self-care for primary dysmenorrhea. It will start at the beginning of the menstruation.
They will note the treatment indicating the dosage in a calendar. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menstrual pain with Visual Analogic Scale (VAS)
VAS is a method of representing subjects' pain on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of pain' and 10 means 'a very high degree of pain.'
Measured: Participants will be followed for 2 menstrual cycles, an expected average of 3 months. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment
Secondary outcomes (1)
Patient satisfaction with Visual Analogic Scale (VAS)
Participants will note the self-care applied to relief menstrual pain indicating the VAS is a method of representing subjects' satisfaction with treatment on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of satisfaction with treatment' and 10 means 'a very high degree of satisfaction with treatment.'
Measured: Participants will be followed for 2 menstrual cycles. Evaluations will be performed at the end of each treatment, when menstrual pain disappears (4-5 days after the beginning of the menstrual bleeding).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Sep 2017
- Primary completion30 Jan 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Crossover
- Model description
- Each woman will be assigned to a sequence of treatments, including two treatments (kinesiotape and usual dysmenorrhea treatment). The sample will be randomized in two different sequences of treatments (kinesiotape/usual treatment or usual treatment/kinesiotape)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Estebanez de Miguel, Universidad de Zaragoza
- Investigators
- Elena Estebanez de Miguel, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290066
- Sponsor's protocol ID
- UZaragoza
- Status last verified
- Jul 2019
- First submitted
- 12 Sep 2017
- Last updated
- 31 Jul 2019
- 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 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesiotaping in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03290066
- Acronym / sponsor ID
- UZaragoza
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Sep 2017 (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.
Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.
Detailed description
Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.
Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common cause of absenteeism and reduced quality of life in women.
Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms.
First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some women have contraindications to these treatments. Consequently, it´s necessary to study alternative treatments to drug treatments. Alternative treatments like heat, massage therapy, acupuncture also are used.
The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s. It is water resistant and retains its properties up to 5 days.
It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each woman will be assigned to a sequence of treatments, including two treatments (kinesiotape and usual dysmenorrhea treatment). The sample will be randomized in two different sequences of treatments (kinesiotape/usual treatment or usual treatment/kinesiotape)
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Active comparator | Device: kinesiotapeKinesiotape will be applied as a self-treatment. All participants will be instructed in an indvidual session and will receive a tutorial video to remember the kinesiotaping procedure. 3 band of a special and hypoallergenic tape (Kinematix Tex) will be attached to the abdominal (2 strips) and lower back (1 strip). Patients will be taped for four days , ıt will start at the beginning of the menstruation. |
| Usual care | Active comparator | Other: Usual careParticipants will use the usual self-care for primary dysmenorrhea. It will start at the beginning of the menstruation. They will note the treatment indicating the dosage in a calendar. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women presenting menstrual pain, 4 or more in VAS.
- Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
- Not have been diagnosed with secondary dysmenorrhea
- Regular menstrual cycles (cycle typical range of 21 to 35 days)
- Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
Key exclusion criteria (7 listed)
- Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
- Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
- Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
- Women who suffer from diseases diagnosed added
- Women to which it has undergone a surgical procedure for the treatment
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 |
|---|---|---|
| kinesiotapeFor the Kinesio taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back. | Device | Kinesiotape |
| Usual careAlso: self-careParticipants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....). | Other | Usual care |
Primary outcome
Change in menstrual pain with Visual Analogic Scale (VAS)
Time frame: Participants will be followed for 2 menstrual cycles, an expected average of 3 months. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment
VAS is a method of representing subjects' pain on a 10 cm linear scale. In this study, a score of 0 means 'a very low degree of pain' and 10 means 'a very high degree of pain.'
1 secondary outcome
Patient satisfaction with Visual Analogic Scale (VAS)
Time frame: Participants will be followed for 2 menstrual cycles. Evaluations will be performed at the end of each treatment, when menstrual pain disappears (4-5 days after the beginning of the menstrual bleeding).
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 31 Jul 2019.
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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.
Elena Estebanez de Miguel, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotape in people with Primary Dysmenorrhea, run by Universidad de Zaragoza at 1 site in Spain.
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 7 inclusion and 7 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 31 Jul 2019. 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 Spain. 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 in menstrual pain with Visual Analogic Scale (VAS) (time frame: Participants will be followed for 2 menstrual cycles, an expected average of 3 months. Evaluations will be performed before, and just after 2 hours, 8 hours, 12 hours, 24 hours, and 48 hours after treatment). 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 31 Jul 2019.