- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474482
Kinesio Taping With and Without Exercise Program in Primary Dysmenorrhea
Comparison of Kinesio Taping With and Without Combined Exercise Program on Pain and Quality of Life in Primary Dysmenorrhea
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- Johar Institute of Professional Studies nabi bakhsh stop, lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kinesio taping with 75 to 100 % stretch and exercises
Kinesio taping with stretching exercises and yoga will be given to patients for 8 weeks.
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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.
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Experimental: kinesio taping without exercises
Kinesio taping alone will be given to patients for 8 weeks.
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Kinesio taping with a full stretch of 75 to 100 % for 2 days session per week without exercises for 8 weeks.
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Active Comparator: kinesio taping without stretch to tape
kinesio taping without any stretch, applied as control for 8 weeks.
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kinesio taping without any stretch for 2 days session per week for total 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MSQ
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF36
Time Frame: 6 months
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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
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6 months
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NPRS
Time Frame: 6 months
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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,
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Afifa Safdar, PhD*, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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