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Kinesio Taping With and Without Exercise Program in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
kinesio taping with exercises
Kinesio taping without exercises
Kinesio taping without stretch as control
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Dysmenorrhea, Kinesiology taping, Menstruation

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johar Institute of Professional Studies nabi bakhsh stop, lahore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

kinesio taping with 75 to 100 % stretch and exercises

kinesio taping without exercises

kinesio taping without stretch to tape

Arm Description

Kinesio taping with stretching exercises and yoga will be given to patients for 8 weeks.

Kinesio taping alone will be given to patients for 8 weeks.

kinesio taping without any stretch, applied as control for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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,

Full Information

First Posted
July 24, 2022
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474482
Brief Title
Kinesio Taping With and Without Exercise Program in Primary Dysmenorrhea
Official Title
Comparison of Kinesio Taping With and Without Combined Exercise Program on Pain and Quality of Life in Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Dysmenorrhea, Kinesiology taping, Menstruation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
blinding
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kinesio taping with 75 to 100 % stretch and exercises
Arm Type
Experimental
Arm Description
Kinesio taping with stretching exercises and yoga will be given to patients for 8 weeks.
Arm Title
kinesio taping without exercises
Arm Type
Experimental
Arm Description
Kinesio taping alone will be given to patients for 8 weeks.
Arm Title
kinesio taping without stretch to tape
Arm Type
Active Comparator
Arm Description
kinesio taping without any stretch, applied as control for 8 weeks.
Intervention Type
Other
Intervention Name(s)
kinesio taping with exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesio taping without exercises
Intervention Description
Kinesio taping with a full stretch of 75 to 100 % for 2 days session per week without exercises for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Kinesio taping without stretch as control
Intervention Description
kinesio taping without any stretch for 2 days session per week for total 8 weeks.
Primary Outcome Measure Information:
Title
MSQ
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SF36
Description
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
Time Frame
6 months
Title
NPRS
Description
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,
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afifa Safdar, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johar Institute of Professional Studies nabi bakhsh stop, lahore
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32379680
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.
Results Reference
background
PubMed Identifier
32415471
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.
Results Reference
background
PubMed Identifier
34442453
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.
Results Reference
background
PubMed Identifier
34360122
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.
Results Reference
background
PubMed Identifier
19459861
Citation
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.
Results Reference
background
PubMed Identifier
26564807
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.
Results Reference
background
PubMed Identifier
32379659
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.
Results Reference
background

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Kinesio Taping With and Without Exercise Program in Primary Dysmenorrhea

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