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Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery

Primary Purpose

Myofascial Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Kinesiotaping
traditional therapy intervention
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both genders with age range between 30 to 45 years will participate in this study.
  • A history of MPS involving upper trapezius for at least 3 months.
  • Moderate to severe pain (VAS score >4).

Exclusion Criteria:

  • The potential participants will be excluded if they meet one of the following criteria:

    • A wound in the affected area
    • A cervical disk lesion
    • Myelopathy or radiculopathy
    • Cervical spine fracture or spondylolisthesis
    • Rheumatoid arthritis,
    • Epilepsy or any psychological disorders

Sites / Locations

  • Faculty Of phyical tehrapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (Kinesio taping group)(Experimental group):

Group B (control group)

Arm Description

This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.

This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month.

Outcomes

Primary Outcome Measures

assessing and quantifying pain exhibited by the patients
Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s The VAS will be used for assessing and quantifying pain exhibited by the patients through a 0-10 scale. Each subject twill be informed to mark the line according to the pain intensity experienced at that particular time where 0 means no pain and 10 means worst conceivable pain

Secondary Outcome Measures

pressure pain threshold (PPT)
A pressure algometer: Pressure algometer(Somedic AB, Farsta, Sweden)will be used for pressure pain threshold (PPT) assessment on the trigger spots. Participants will be informed to elucidate when the pressure sensation became painful and to immediately release the pressure. The most painful point will be marked by a waterproof marker on the initial visit. The average of three measurements will be recorded

Full Information

First Posted
January 15, 2022
Last Updated
March 1, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05265884
Brief Title
Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery
Official Title
Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (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 purpose of the study is to evaluate the effect of Kinesio taping on myofascial pain syndrome post neck dissection surgery.
Detailed Description
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures. Subjects: Sixty patients from both genders who have cervical myofascial pain syndrome (MPS) following a neck dissection surgery will participate in this study. Their ages will be ranged from 30 to 45 years. The participants will be selected from the National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Kinesio taping group): This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month. 1.1(b) Group B This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month. Equipment: 2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s . 2.1.b- A pressure algometer: - A pressure algometer will be used for pressure pain threshold (PPT) assessment on the trigger spots. It contains a rubber disk (1 cm2surface), attached to a pressure pole and inserted into a gauge, for recording the pressure in kilograms . 2.1.C-Goniometer: The term goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement". Goniometer has different types; the most used is the universal standard goniometer, which is either made with plastic or metal tool. It consists of a stationary arm, a movable arm, and a fulcrum. By aligning this with the axis of a joint, the degree of motion can be measured in a single plane . -The active ROM of neck joint (lateral flexion and rotation on both sides.) will be measured using a universal standard goniometer when the patient is in sitting position. 2.2-Therapeutic equipment and tools: Kinesio tape: The tape (Kinesio Tex Tape; Kinesio Holding Corporation, Albuquerque, NM) is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Kinesio taping group)(Experimental group):
Arm Type
Experimental
Arm Description
This group includes 30 patients who will receive Kinesiotaping, in additional to traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.
Arm Title
Group B (control group)
Arm Type
Active Comparator
Arm Description
This group includes 30 patients who will receive traditional treatment only (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for 1 month.
Intervention Type
Device
Intervention Name(s)
Kinesiotaping
Intervention Description
The tape is waterproof, porous, and adhesive. The width is 5 cm and thickness of 0.5 mm will be used in this study. This tape is with elastic core wrapped within cotton and capable of stretching up to 140-150%, applies heat-sensitive acrylic adhesive to avoid risk of latex allergy .The tape without medicinal properties is water resistant and can remain on the skin for 3 to 5 days. It will be applied two times per week for one month
Intervention Type
Behavioral
Intervention Name(s)
traditional therapy intervention
Intervention Description
traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.
Primary Outcome Measure Information:
Title
assessing and quantifying pain exhibited by the patients
Description
Visual analogue scale (VAS): The Visual analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain, quality of life and anxiety since the 1920s. It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable". The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm. The VAS was initially used in psychology for the measurement of mood disorders, and was used for the measurement of pain from the mid-1960s The VAS will be used for assessing and quantifying pain exhibited by the patients through a 0-10 scale. Each subject twill be informed to mark the line according to the pain intensity experienced at that particular time where 0 means no pain and 10 means worst conceivable pain
Time Frame
1 month
Secondary Outcome Measure Information:
Title
pressure pain threshold (PPT)
Description
A pressure algometer: Pressure algometer(Somedic AB, Farsta, Sweden)will be used for pressure pain threshold (PPT) assessment on the trigger spots. Participants will be informed to elucidate when the pressure sensation became painful and to immediately release the pressure. The most painful point will be marked by a waterproof marker on the initial visit. The average of three measurements will be recorded
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Range of motion
Description
Neck ROM will be measured using the universal standard goniometer while patients in sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight and strapped to the back of the chair. Subject's ankles, knees and hips will be positioned at right angle and arms will be folded across the chest to minimize thoracic movement. The active ROM of the neck (lateral flexion and rotation on both sides.) will be measured using the universal standard goniometer when the patient is in sitting position.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders with age range between 30 to 45 years will participate in this study. A history of MPS involving upper trapezius for at least 3 months. Moderate to severe pain (VAS score >4). Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: A wound in the affected area A cervical disk lesion Myelopathy or radiculopathy Cervical spine fracture or spondylolisthesis Rheumatoid arthritis, Epilepsy or any psychological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshira Mahmoud, Master
Phone
01226208270
Email
moshiramedhat92@gmial.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mohamed, bachelor
Phone
01000184923
Email
ahmed.g.mohamed770@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy
Organizational Affiliation
teaching assistant at faculty of physical therapy Cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Of phyical tehrapy
City
Dokki
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy
Phone
02 37617691
Email
Info@pt.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery

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