Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy

March 7, 2022 updated by: Sara Mohamed, Cairo University
The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy

Study Overview

Detailed Description

Up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. Almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.In mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .In many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.Non-drug treatments are found to being effective for the treatment of muscle cramps. Non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.This study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11311
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women who are suffering from calf cramps.
  • Their age range from 25 to 35 years.
  • Their body mass index range from 25 to 29.9 kg/m2 .

Exclusion Criteria:

  • Skin abnormalities (skin malignancy in the treated area or burned).
  • History of previous back surgery.
  • Neuromuscular diseases like multiple sclerosis.
  • Sensory disturbances.
  • Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
  • Systemic disease of musculoskeletal system.
  • Viscerogenic cause of back pain.
  • Also, women who have eclampsia or pre-eclampsia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesio-tape application+stretchinge exercises
the patient received A"Ystrip"of KT was applied to the testing leg 30% tension for 48h and was asked to assume comfortable supine position and the therapist applied 15 seconds of passive stretch to the calf muscle followed by 30 seconds of rest and this exercise was repeated 6 times per session for 2 days and ecieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.
KT is comprised of a polymer elastic strand warped by 100% cotton fibers and designed to allow a longitudinal stretch of 55-60% of its resting length.
15 seconds of passive stretching exercise for calf muscle followed by 30 seconds of rest
instructions about dealing with calf cramps by self low sustained stretch of calf muscle
Experimental: self low sustained strestch
the patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.
instructions about dealing with calf cramps by self low sustained stretch of calf muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calf pain intensity
Time Frame: 2days
cramp VAS is used to measure pain intensity
2days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight bearing ankle dorsiflexion ROM
Time Frame: 2days
weight bearing ankle dorsiflexion ROM is measured by digital inclinometer
2days
straight leg raising ROM
Time Frame: 2days
straight leg raising ROM is measured by digital inclinometer
2days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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