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DysmenorrheaNCT05355194

Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea

A study testing Kinesiotape and Pelvic Tilts in people with Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine the effects of kinesiotaping with \& without pelvic tilts on pain \& menstrual distress in females with dysmenorrhea. This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea. Read more about this study

Who is it for?
Ages 18 to 30 years, women only
Conditions the study is for
Dysmenorrhea
What is being tested?
Kinesiotape and Pelvic Tilts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
20 Apr 2022to 19 Oct 2022
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

  • Age 18-30 years
  • Nulliparous
  • Regular menstrual cycles
  • Primary dysmenorrhea (diagnosed via WaLLID tool)

Who cannot join

  • Allergic to kinesiotape
  • Skin disorders
  • Uterine fibroids
  • Endometriosis
  • Polycystic Ovarian Syndrome

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • University of Sialkot

    Sialkot, Punjab Province, 54700

Other trials in Pakistan

About this study

Official title: Effects of Kinesiotaping With and Without Pelvic Tilts on Pain and Menstrual Distress in Females With Dysmenorrhea

This study aims to determine the effects of kinesiotaping with \& without pelvic tilts on pain \& menstrual distress in females with dysmenorrhea. This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea.

Read the detailed description

This study will be a randomized controlled trial to compare the effectiveness of kinesiotaping with and without pelvic tilts in subjects with primary dysmenorrhea. Subjects with primary dysmenorrhea meeting the predetermined eligibility criteria will be divided into two groups using the random sequence generation method. Pre-intervention responses shall be taken during the first menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool \& Menstrual Distress Questionnaire.

Subjects in Group A shall be treated with kinesiotaping and pelvic tilts while subjects in Group B shall be treated with kinesiotaping only. Each subject will receive 02 treatment sessions during the second \& third menstrual cycles. Post-intervention responses shall be recorded in the fourth menstrual cycle using the Numeric Pain Rating Scale, WaLLID tool \& Menstrual Distress Questionnaire.

Conditions
Dysmenorrhea
Being tested
Kinesiotape, Pelvic Tilts
Keywords
dysmenorrhea, Active stretching, Kinesiotape
Medical subject headings
Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KinesiotapeOther

    Patients will be instructed to inhale while taping the application. The tape will be applied in a vertical direction from just below the navel to the pubic region, another tape will be applied over the initial tape in the horizontal direction with minimal stretch. Another tape will be applied over the lumbosacral region making a V shape. The arms of V shall lie over the lumbar region while the base shall rest over the caudal region. Taping will be maintained for at least 48 hours.

    The interventions shall be applied for two consecutive menstrual cycles.

  • Pelvic TiltsOther

    Patients will be asked to lie in a supine position with legs bent and toes facing forward. Afterward, they will be instructed to pull their belly inwards while pushing pelvis towards the ceiling and keep hip muscles tightened. This position will be maintained for 5 seconds with 3 sets of 20 repetitions. Pelvic tilts must be performed throughout the menstrual cycle.

Study groups in NCT05355194
Study groupRoleWhat they receive
Group A: Kinesiotaping with pelvic tiltsExperimentalKinesiotape will be applied to patients. In addition, patients will be instructed to perform pelvic tilts.
Receives: Other: Kinesiotape; Other: Pelvic Tilts
Group B: Kinesiotaping without pelvic tiltsActive comparatorKinesiotape will be applied to patients.
Receives: Other: Kinesiotape

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is an outcome measure that is unidimensional measure of pain intensity in adults. It is segmented numeric version of Visual Analogue Scale (VAS) in which respondents select a whole number from 0-10 that best reflects the intensity of their pain.

    Measured: up to 12 weeks

  2. WaLLID Scale:

    Proposed in 2018 by Teherán et al., working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD; based on pain score and use of painkillers) is a combination of multiple scales, which has been developed with the goal of measuring the severity of dysmenorrhea and predicting the resultant activity limitation.

    Measured: up to 12 weeks

  3. Menstrual Distress Questionnaire:

    Menstrual Distress Questionnaire is a tool developed by Moss that measures the severity and symptoms associated with menstruation. Kim designed a revised version of Menstrual Distress Questionnaire to determine the type of discomfort during menstruation wit 35 questions.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start20 Apr 2022
  3. Primary completion1 Oct 2022
  4. Study completion19 Oct 2022

Resources

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
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05355194
Sponsor's protocol ID
REC/Lhr/22/0505 Izza
Status last verified
Oct 2022
First submitted
21 Apr 2022
Last updated
24 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reddish S. Dysmenorrhoea. Aust Fam Physician. 2006 Nov;35(11):842-4, 846-9.

    PubMed 17099800

  • Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.

    PubMed 24284871

  • Johnston L. Menstrual pain (dysmenorrhoea). Professional Nursing Today. 2014;18(1):13-4.

  • Smith R, Kaunitz A. Primary dysmenorrhea in adult women: clinical features and diagnosis. Alphen aan den Rijn: Wolters Kluwer. 2015.

  • Lundeberg T, Bondesson L, Lundstrom V. Relief of primary dysmenorrhea by transcutaneous electrical nerve stimulation. Acta Obstet Gynecol Scand. 1985;64(6):491-7. doi: 10.3109/00016348509156727.

    PubMed 3904321

  • Patel F, Dhupkar A. Effect of Kinesiotaping and Pelvic Tilts on Menstrual Symptom Questionnaire and Visual Analogue Scale in Primary Dysmenorrhoea in Females Aged 18-30 Years.

  • Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671.

    PubMed 26564807

  • Roozbahani RE, Najad RM. A comparison of the effect of stretching exercises and kinesio taping on the primary dysmenorrhea of high school girls. J Arak Uni Med Sci. 2015;18(97):1-8.

  • Shahr-Jerdy S, Hosseini RS, Gh ME. Effects of stretching exercises on primary dysmenorrhea in adolescent girls. Biomedical Human Kinetics. 2012;4(1):127-32.

  • Ahmadi Barati A, Farhadi L, Khalily M. Comparison of the Effect of Stretching Exercises and Combination of Massage-Stretching Exercises on Primary Dysmenorrhea of Female Students of Razi University of Kermanshah. Journal of Clinical Research in Paramedical Sciences. 2021;10(1).

  • Arshad S, Qureshi MF, Deeba F, Sarshad S, Shiraz S, Farooq S, et al. To compare the effectiveness of taping technique and hydrotherapy in treatment of primary dysmenorrhea. Inter J Endor Health Sci Res. 2018;6(3):34-42.

Questions about this trial

What is this clinical trial studying?

A study testing Kinesiotape and Pelvic Tilts in people with 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 5 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 24 Oct 2022. 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. 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?

Numeric Pain Rating Scale (NPRS) (time frame: up to 12 weeks). The study lists 3 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 NCT05355194, which also lists 11 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 24 Oct 2022.

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