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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05355194
Other study ID # REC/Lhr/22/0505 Izza
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2022
Est. completion date October 19, 2022

Study information

Verified date October 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 19, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Age 18-30 years - Nulliparous - Regular menstrual cycles - Primary dysmenorrhea (diagnosed via WaLLID tool) Exclusion Criteria: - Allergic to kinesiotape - Skin disorders - Uterine fibroids - Endometriosis - Polycystic Ovarian Syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesiotape
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 Tilts
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.

Locations

Country Name City State
Pakistan University of Sialkot Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

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.

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

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. Review. — View Citation

Lundeberg T, Bondesson L, Lundström V. Relief of primary dysmenorrhea by transcutaneous electrical nerve stimulation. Acta Obstet Gynecol Scand. 1985;64(6):491-7. — View Citation

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.

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

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.

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

Tomás-Rodríguez MI, Palazón-Bru A, Martínez-St John DRJ, Toledo-Marhuenda JV, Asensio-García MDR, Gil-Guillén 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 12 weeks
Primary 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. up to 12 weeks
Primary 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. up to 12 weeks
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