Primary DysmenorrheaNCT05909956
Effects of Therapeutic Tapping in Primary Dysmenorrhea
A study testing KinesioTape and General Physio session in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial summary
Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- KinesioTape and General Physio session
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jun 2023to 31 Dec 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women with Primary dysmenorrhea
- Aged between 18 and 25 years.
- Having a regular menstruation cycle (28 ± 7 days)
- Severity of menstrual pain on VAS: 4 and over in the previous 6 months.
Who cannot join
- Secondary dysmenorrhea
- Childbirth, pelvic surgery, use of an intrauterine device,
- Malignant condition
- Chronic medication; antidepressants or oral contraceptives for at least 6 months prior to study
- Not volunteering to participate in the study
- Having an allergy to K.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea
Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. This study is planned to determine the effects of KT on clinical symptoms, QOL and academic performance of students with Primary dysmenorrhea.
Read the detailed description
Literature suggested that kinesio tape technique, one of the effective physiotherapy technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled trial, with three groups.
Participants in the experimental group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament with general physical therapy session. Sham group (ST) group will receive sham taping with general physical therapy session. Participants in Control group (CG) will receive only general physical therapy session.
All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL and academic performance.
- Conditions
- Primary Dysmenorrhea
- Being tested
- KinesioTape, Sham Tape, General Physio session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesioTapeOther
The kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle)
Sham TapeOther
This group will receive KT tapping without stretch on the sacral and suprapubic region.
General Physio sessionOther
General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck \& upper trapezius, arm \& shoulder girdle, triceps brachii, teres major \& minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day.
| Study group | Role | What they receive |
|---|---|---|
| KT Group | Experimental | This group will receive Abdominal KT tape (From initial 4 h to 72 h of menstruation). General physio session will also be given to this group. Receives: Other: KinesioTape |
| ST Group | Sham comparator | This group will receive Abdominal KT tape (without strech) from initial 4 h to 72 h of menstruation. General physio session will also be given to this group. Receives: Other: Sham Tape |
| CT Group | Other | this group will receive General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck \& upper trapezius, arm \& shoulder girdle, triceps brachii, teres major \& minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day. Receives: Other: General Physio session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.
Measured: Changes from Baseline to 8th week
Visual Analog Scale
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.
Measured: Changes from 8th week to 12th week
Menstrual Symptom Questionnaire
The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.
Measured: Changes from Baseline to 8th week
Menstrual Symptom Questionnaire
The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.
Measured: Changes from 8th week to 12th week
Health-related life quality
Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.
Measured: Changes from Baseline to 8th week
Health-related life quality
Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.
Measured: Changes from 8th week to 12th week
Secondary outcomes (2)
Self-Structured 20-items Academic Performance questionnaire
It is a 20 items questionnaire, divided under 5 subheadings, in a form of check list "yes or No" response, was developed to measure the impacts of menstrual symptoms on academic performance.
Measured: Changes from Baseline to 8th week
Self-Structured 20-items Academic Performance questionnaire
It is a 20 items questionnaire, divided under 5 subheadings, in a form of check list "yes or No" response, was developed to measure the impacts of menstrual symptoms on academic performance.
Measured: Changes from 8th week to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start7 Jun 2023
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909956
- Sponsor's protocol ID
- RiphahIU Sidra Malik
- Status last verified
- Jan 2024
- First submitted
- 11 Jun 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dogan H, Eroglu S, Akbayrak T. The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.
PubMed 32379659Raju J, Suguna M. A study to assess the effect of menstrual symptoms on academic performance among nursing students at selected colleges in Tamil Nadu, India. Int J Appl Res. 2017;3(3):78-80.
Mejias-Gil E, Garrido-Ardila EM, Montanero-Fernandez J, Jimenez-Palomares M, Rodriguez-Mansilla J, Gonzalez Lopez-Arza MV. Kinesio Taping vs. Auricular Acupressure for the Personalised Treatment of Primary Dysmenorrhoea: A Pilot Randomized Controlled Trial. J Pers Med. 2021 Aug 19;11(8):809. doi: 10.3390/jpm11080809.
PubMed 34442453Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
PubMed 32379680
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05909956
- Acronym / sponsor ID
- RiphahIU Sidra Malik
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 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.
Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. This study is planned to determine the effects of KT on clinical symptoms, QOL and academic performance of students with Primary dysmenorrhea.
Detailed description
Literature suggested that kinesio tape technique, one of the effective physiotherapy technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled trial, with three groups.
Participants in the experimental group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament with general physical therapy session. Sham group (ST) group will receive sham taping with general physical therapy session. Participants in Control group (CG) will receive only general physical therapy session.
All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL and academic performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KT Group | Experimental | Other: KinesioTapeThis group will receive Abdominal KT tape (From initial 4 h to 72 h of menstruation). General physio session will also be given to this group. |
| ST Group | Sham comparator | Other: Sham TapeThis group will receive Abdominal KT tape (without strech) from initial 4 h to 72 h of menstruation. General physio session will also be given to this group. |
| CT Group | Other | Other: General Physio sessionthis group will receive General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck \& upper trapezius, arm \& shoulder girdle, triceps brachii, teres major \& minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous women with Primary dysmenorrhea
- Aged between 18 and 25 years.
- Having a regular menstruation cycle (28 ± 7 days)
- Severity of menstrual pain on VAS: 4 and over in the previous 6 months.
Key exclusion criteria (6 listed)
- Secondary dysmenorrhea
- Childbirth, pelvic surgery, use of an intrauterine device,
- Malignant condition
- Chronic medication; antidepressants or oral contraceptives for at least 6 months prior to study
- Not volunteering to participate in the study
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 |
|---|---|---|
| KinesioTapeThe kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle) | Other | KT Group |
| Sham TapeThis group will receive KT tapping without stretch on the sacral and suprapubic region. | Other | ST Group |
| General Physio sessionGeneral physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck \& upper trapezius, arm \& shoulder girdle, triceps brachii, teres major \& minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day. | Other | CT Group |
Primary outcome
Visual Analog Scale
Time frame: Changes from Baseline to 8th week
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.
Visual Analog Scale
Time frame: Changes from 8th week to 12th week
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.
Menstrual Symptom Questionnaire
Time frame: Changes from Baseline to 8th week
The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.
Menstrual Symptom Questionnaire
Time frame: Changes from 8th week to 12th week
The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.
Health-related life quality
Time frame: Changes from Baseline to 8th week
Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.
Health-related life quality
Time frame: Changes from 8th week to 12th week
Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.
2 secondary outcomes
Self-Structured 20-items Academic Performance questionnaire
Time frame: Changes from Baseline to 8th week
Self-Structured 20-items Academic Performance questionnaire
Time frame: Changes from 8th week to 12th week
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 19 Jan 2024.
- Background: PubMed 32379659Dogan H, Eroglu S, Akbayrak T. The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.
- BackgroundRaju J, Suguna M. A study to assess the effect of menstrual symptoms on academic performance among nursing students at selected colleges in Tamil Nadu, India. Int J Appl Res. 2017;3(3):78-80.
- Background: PubMed 34442453Mejias-Gil E, Garrido-Ardila EM, Montanero-Fernandez J, Jimenez-Palomares M, Rodriguez-Mansilla J, Gonzalez Lopez-Arza MV. Kinesio Taping vs. Auricular Acupressure for the Personalised Treatment of Primary Dysmenorrhoea: A Pilot Randomized Controlled Trial. J Pers Med. 2021 Aug 19;11(8):809. doi: 10.3390/jpm11080809.
- Background: PubMed 32379680Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
- 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.
Huma Riaz, PHD* principal investigator
Riphah International 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 KinesioTape and General Physio session in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
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 4 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 19 Jan 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 Analog Scale (time frame: Changes from Baseline to 8th week). The study lists 6 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 NCT05909956, which also lists 4 linked publications.
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 19 Jan 2024.