Effects of Therapeutic Tapping in Primary Dysmenorrhea

Sponsor

Riphah International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05909956

Collaborator

(none)

Enrollment

Arms

6.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Dysmenorrhea	Other: KinesioTape Other: Sham Tape Other: General Physio session	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea

Anticipated Study Start Date :

Jun 7, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KT Group 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.	Other: KinesioTape The kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework 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. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle)
Sham Comparator: ST Group 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.	Other: Sham Tape This group will receive KT tapping without stretch on the sacral and suprapubic region.
Other: CT Group 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.	Other: General Physio session 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.

Arm

Intervention/Treatment

Experimental: KT Group

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.

Other: KinesioTape

The kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework 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. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle)

Sham Comparator: ST Group

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.

Other: Sham Tape

This group will receive KT tapping without stretch on the sacral and suprapubic region.

Other: CT Group

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.

Other: General Physio session

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.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale [Changes from Baseline to 8th 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.
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.
Menstrual Symptom Questionnaire [Changes from Baseline to 8th 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.
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.
Health-related life quality [Changes from Baseline to 8th 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.
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.

Secondary Outcome Measures

Self-Structured 20-items Academic Performance questionnaire [Changes from Baseline to 8th 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Huma Riaz, PHD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Huma Riaz, Associate Professor, Riphah International University

ClinicalTrials.gov Identifier:

NCT05909956

Other Study ID Numbers:

RiphahIU Sidra Malik

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dysmenorrhea

Study Results

No Results Posted as of Jun 18, 2023