NCT05265884

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

January 15, 2022

Last Update Submit

March 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pressure pain threshold (PPT)

    1 month

Other Outcomes (1)

  • Range of motion

    1 month

Study Arms (2)

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

EXPERIMENTAL

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: KinesiotapingBehavioral: traditional therapy intervention

Group B (control group)

ACTIVE COMPARATOR

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

Interventions

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

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

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

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

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of phyical tehrapy

Dokki, Giza Governorate, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • faculty of physical therapy

    teaching assistant at faculty of physical therapy Cairo university

    STUDY DIRECTOR

Central Study Contacts

Moshira Mahmoud, Master

CONTACT

Ahmed Mohamed, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Moshira Medhat ,Assistant lecturer of physical therapy,cairo university

Study Record Dates

First Submitted

January 15, 2022

First Posted

March 4, 2022

Study Start

March 1, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations