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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05474482
Other study ID # REC/RCR & AHS/22/0513
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date August 1, 2022

Study information

Verified date September 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary dysmenorrhea (PD) is a common gynecological problem among adolescents and adult women. Treatment of PD includes various drugs and therapies such as kinesio taping (KT) and exercise. There are various studies that have individually explored the effects of KT and combined exercises. A randomized controlled trial (RCT) will be conducted to compare the effects of KT combined a combined exercise program and the effects of KT alone on pain and quality of life in females suffering from PD.


Description:

Primary dysmenorrhea (PD) is a common gynecological problem among adolescents and adult women. Treatment of PD includes various drugs and therapies such as kinesio taping (KT) and exercise. There are various studies that have individually explored the effects of KT and combined exercises. A randomized controlled trial (RCT) will be conducted to compare the effects of KT combined a combined exercise program and the effects of KT alone on pain and quality of life in females suffering from PD. The study will involve 45 women who experience dysmenorrhea. divided into three groups, group A, group B and Group C. Group A will receive the combined exercise program (The exercise protocol which included stretching exercises, yoga position, Kegel exercise, bridging exercise) for 45 minutes with 3 sessions per week for eight weeks. The Group A will receive KT intervention for two days per week from the estimated day of ovulation till the next period occurs, for eight weeks. The group B will receive KT that is used to treat the symptoms of primary dysmenorrhea for 45 minutes with 2 sessions per week for eight weeks. The Group C will receive conventional therapy with 3 sessions per week to eight weeks. Numeric pain rating scale (NPRS), Short form 36 Questionnaire (SF-36) and Menstrual symptom questionnaire (MSQ) will be used to assess the pain and quality of life at baseline and at the end of 8th week.Total duration of study will be six months. Physiotherapy can be a very successful treatment for PD with the benefit that the patient may occasionally be able to carry out the treatment independently. recommendations for manual therapy, acupressure, Kinesio tape, electrotherapy, and other forms of treatment. There have also been discussions about therapeutic activities or progressive relaxation techniques. It is stated in literature that most effective exercise programs were stretching and isometric exercises for 8 weeks for pain intensity and duration, yoga for 12 weeks for pain intensity and quality of life, and aerobic exercises for 12 weeks for quality of life and KT for 12 weeks for pain and quality of life in PD. There are many various tapes available, each with a different type, substance, and application, according to the most recent research in 2021.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Women between the ages of 18 and 30 who are nulliparous and have normal menstrual cycles (28 to 7 days). - Menstrual pain severity rated at 4 or higher on the NPRS over the previous six months. Exclusion Criteria: - Secondary dysmenorrhea Pelvic surgery (rectum and anal problems, etc.), pelvic organ prolapses, and malignant conditions (uterine cancer, ovarian cancer, cervical cancer, etc.) - Utilizing oral contraceptives for at least six months before. - Allergic to KT tape - Use of antidepressants

Study Design


Related Conditions & MeSH terms


Intervention

Other:
kinesio taping with exercises
Kinesio taping with full stretch of 75 to 100 % for 2 days session per week and exercises for 3 days session per week for total 8 weeks.
Kinesio taping without exercises
Kinesio taping with a full stretch of 75 to 100 % for 2 days session per week without exercises for 8 weeks.
Kinesio taping without stretch as control
kinesio taping without any stretch for 2 days session per week for total 8 weeks.

Locations

Country Name City State
Pakistan Johar Institute of Professional Studies nabi bakhsh stop, lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Blakey H, Chisholm C, Dear F, Harris B, Hartwell R, Daley AJ, Jolly K. Is exercise associated with primary dysmenorrhoea in young women? BJOG. 2010 Jan;117(2):222-4. doi: 10.1111/j.1471-0528.2009.02220.x. — View Citation

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. — View Citation

Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15. — View Citation

Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832. — View Citation

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. — View Citation

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. — View Citation

Toprak 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MSQ Menstrual symptoms were assessed using the Menstrual Symptom Questionnaire (MSQ). The questionnaire has 24 items; 19 of them (emotional, physical, and pain) assess symptoms, and three examine symptom management strategies. The following is how the things are rated using a Likert-style scale: 1 denotes never, 2 rare, 3 irregular, 4 often, and 5 constant. 6 months
Secondary SF36 The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study 6 months
Secondary NPRS NPRS with each centimetre denoting one unit of pain severity, to indicate how much pain they were experiencing. "0" meant there was no pain, while "10" meant there was a lot of agonyas used to measure pain. The participants marked a "x" on a 10 cm line, 6 months
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