Effects of Kinesiotaping With and Without Pelvic Tilts in Dysmenorrhea

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05355194
Collaborator
(none)
30
1
2
7
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Kinesiotape
  • Other: Pelvic Tilts
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Kinesiotaping With and Without Pelvic Tilts on Pain and Menstrual Distress in Females With Dysmenorrhea
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A: Kinesiotaping with pelvic tilts

Kinesiotape will be applied to patients. In addition, patients will be instructed to perform pelvic tilts.

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.

Other: 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.

Active Comparator: Group B: Kinesiotaping without pelvic tilts

Kinesiotape will be applied to patients.

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.

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale (NPRS) [up to 12 weeks]

    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.

  2. WaLLID Scale: [up to 12 weeks]

    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.

  3. Menstrual Distress Questionnaire: [up to 12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Sialkot Sialkot Punjab Pakistan 54700

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Ghulam Fatima, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05355194
Other Study ID Numbers:
  • REC/Lhr/22/0505 Izza
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022