Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kinesiotape
Pelvic Tilts
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring dysmenorrhea, Active stretching, Kinesiotape
Eligibility Criteria
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
Sites / Locations
- University of Sialkot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A: Kinesiotaping with pelvic tilts
Group B: Kinesiotaping without pelvic tilts
Arm Description
Kinesiotape will be applied to patients. In addition, patients will be instructed to perform pelvic tilts.
Kinesiotape will be applied to patients.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05355194
First Posted
April 21, 2022
Last Updated
October 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05355194
Brief Title
Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea
Official Title
Effects of Kinesiotaping With and Without Pelvic Tilts on Pain and Menstrual Distress in Females With Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 19, 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
dysmenorrhea, Active stretching, Kinesiotape
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Kinesiotaping with pelvic tilts
Arm Type
Experimental
Arm Description
Kinesiotape will be applied to patients. In addition, patients will be instructed to perform pelvic tilts.
Arm Title
Group B: Kinesiotaping without pelvic tilts
Arm Type
Active Comparator
Arm Description
Kinesiotape will be applied to patients.
Intervention Type
Other
Intervention Name(s)
Kinesiotape
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pelvic Tilts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
up to 12 weeks
Title
WaLLID Scale:
Description
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.
Time Frame
up to 12 weeks
Title
Menstrual Distress Questionnaire:
Description
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.
Time Frame
up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sialkot
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17099800
Citation
Reddish S. Dysmenorrhoea. Aust Fam Physician. 2006 Nov;35(11):842-4, 846-9.
Results Reference
background
PubMed Identifier
24284871
Citation
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.
Results Reference
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Citation
Johnston L. Menstrual pain (dysmenorrhoea). Professional Nursing Today. 2014;18(1):13-4.
Results Reference
background
Citation
Smith R, Kaunitz A. Primary dysmenorrhea in adult women: clinical features and diagnosis. Alphen aan den Rijn: Wolters Kluwer. 2015.
Results Reference
background
PubMed Identifier
3904321
Citation
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.
Results Reference
background
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.
Results Reference
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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
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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.
Results Reference
background
Citation
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.
Results Reference
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Citation
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).
Results Reference
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Citation
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.
Results Reference
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Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea
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