Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery

The purpose of the study is to evaluate the effect of Kinesio taping on myofascial pain syndrome post neck dissection surgery.

Study Overview

• Status: Recruiting
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Device: Kinesiotaping; Behavioral: traditional therapy intervention

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.

1. 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.

2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moshira Mahmoud, Master; Phone Number: 01226208270; Email: moshiramedhat92@gmial.com
• Study Contact Backup: Name: Ahmed Mohamed, bachelor; Phone Number: 01000184923; Email: ahmed.g.mohamed770@gmail.com

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12611
      • Recruiting
      • Faculty Of phyical tehrapy
      • Contact: faculty of physical therapy; Phone Number: 02 37617691; Email: Info@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A (Kinesio taping group)(Experimental 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.	Device: Kinesiotaping; 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; Behavioral: traditional therapy intervention; traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.
ACTIVE_COMPARATOR: Group B (control group); 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.	Behavioral: traditional therapy intervention; traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	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.	1 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: faculty of physical therapy, teaching assistant at faculty of physical therapy Cairo university

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (ACTUAL): March 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: P.T.REC/012/003435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No