Effects of Therapeutic Tapping in Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Other: KinesioTape; Other: General Physio session; Other: Sham Tape

• Registration Number: NCT05909956
• Lead Sponsor: Riphah International University

Brief Summary

Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. This study is planned to determine the effects of KT on clinical symptoms, QOL and academic performance of students with Primary dysmenorrhea.

Detailed Description

Literature suggested that kinesio tape technique, one of the effective physiotherapy technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled trial, with three groups.

Participants in the experimental group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament with general physical therapy session. Sham group (ST) group will receive sham taping with general physical therapy session. Participants in Control group (CG) will receive only general physical therapy session.

All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL and academic performance.

Study Timeline

• Study Start: 2023-06-07
• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-11
• Study First Posted: 2023-06-18
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

• Nulliparous women with Primary dysmenorrhea
• Aged between 18 and 25 years.
• Having a regular menstruation cycle (28 ± 7 days)
• Severity of menstrual pain on VAS: 4 and over in the previous 6 months.

Exclusion Criteria

• Secondary dysmenorrhea
• Childbirth, pelvic surgery, use of an intrauterine device,
• Malignant condition
• Chronic medication; antidepressants or oral contraceptives for at least 6 months prior to study
• Not volunteering to participate in the study
• Having an allergy to K.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KT Group	KinesioTape	This group will receive Abdominal KT tape (From initial 4 h to 72 h of menstruation). General physio session will also be given to this group.
CT Group	General Physio session	this group will receive General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck \& upper trapezius, arm \& shoulder girdle, triceps brachii, teres major \& minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day.
ST Group	Sham Tape	This group will receive Abdominal KT tape (without strech) from initial 4 h to 72 h of menstruation. General physio session will also be given to this group.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	Changes from 8th week to 12th week	It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.
Health-related life quality	Changes from 8th week to 12th week	Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.
Menstrual Symptom Questionnaire	Changes from 8th week to 12th week	The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.

Secondary Outcome Measures

Name	Time	Method
Self-Structured 20-items Academic Performance questionnaire	Changes from 8th week to 12th week	It is a 20 items questionnaire, divided under 5 subheadings, in a form of check list "yes or No" response, was developed to measure the impacts of menstrual symptoms on academic performance.

Trial Locations

Locations (1)

Iman girl hostels; 🇵🇰 Islamabad, Pakistan