Effect of Kinesiotaping on Myofascial Pain Syndrome Post Neck Dissection Surgery

NCT ID: NCT05265884

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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.

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.

Conditions

Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Kinesiotaping

Intervention Type: DEVICE

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

traditional therapy intervention

Intervention Type: BEHAVIORAL

traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.

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.

Group Type: ACTIVE_COMPARATOR

traditional therapy intervention

Intervention Type: BEHAVIORAL

traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.

Interventions

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

Intervention Type: DEVICE

traditional therapy intervention

traditional treatment (ROM exercises, stretching exercises, and Deep friction message) 3 times per week for one month.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moshira Medhat Mahmoud Esmail

Moshira Medhat ,Assistant lecturer of physical therapy,cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

faculty of physical therapy

Role: STUDY_DIRECTOR

teaching assistant at faculty of physical therapy Cairo university

Locations

Faculty Of phyical tehrapy

Dokki, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Moshira Mahmoud, Master

Role: CONTACT

moshiramedhat92@gmial.com

01226208270

Ahmed Mohamed, bachelor

Role: CONTACT

ahmed.g.mohamed770@gmail.com

01000184923

Facility Contacts

faculty of physical therapy

Role: primary

Info@pt.cu.edu.eg

02 37617691

Other Identifiers

P.T.REC/012/003435

Identifier Type: -

Identifier Source: org_study_id