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

Primary Purpose

Calf Cramps During Pregnancy

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
kinesio-tape
stretching exercise
instructions about dealing with calf cramps
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calf Cramps During Pregnancy focused on measuring kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Kinesio-tape application+stretchinge exercises

self low sustained strestch

Arm Description

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.

the patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.

Outcomes

Primary Outcome Measures

calf pain intensity
cramp VAS is used to measure pain intensity

Secondary Outcome Measures

weight bearing ankle dorsiflexion ROM
weight bearing ankle dorsiflexion ROM is measured by digital inclinometer
straight leg raising ROM
straight leg raising ROM is measured by digital inclinometer

Full Information

First Posted
March 7, 2022
Last Updated
March 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05281289
Brief Title
Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
Official Title
Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calf Cramps During Pregnancy
Keywords
kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio-tape application+stretchinge exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
self low sustained strestch
Arm Type
Experimental
Arm Description
the patient recieved instructions about dealing with calf cramps with self low sustained stretch of calf muscle.
Intervention Type
Other
Intervention Name(s)
kinesio-tape
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
stretching exercise
Intervention Description
15 seconds of passive stretching exercise for calf muscle followed by 30 seconds of rest
Intervention Type
Other
Intervention Name(s)
instructions about dealing with calf cramps
Intervention Description
instructions about dealing with calf cramps by self low sustained stretch of calf muscle
Primary Outcome Measure Information:
Title
calf pain intensity
Description
cramp VAS is used to measure pain intensity
Time Frame
2days
Secondary Outcome Measure Information:
Title
weight bearing ankle dorsiflexion ROM
Description
weight bearing ankle dorsiflexion ROM is measured by digital inclinometer
Time Frame
2days
Title
straight leg raising ROM
Description
straight leg raising ROM is measured by digital inclinometer
Time Frame
2days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

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

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