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Kinesio Tape Application With EDF Technique on Active Trigger Points of Upper Trapezius Muscle

Primary Purpose

Myofascial Pain Syndrome, Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape
Sham Kinesio Tape
Sponsored by
Haydarpasa Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

The inclusion criteria:

  • presence of an at least one active TrP and palpable taut band in the UT muscle
  • pain duration less than 3 months
  • pain Visual Analog Score VAS≥4
  • being between 18 and 50 years of age

The exclusion criteria:

  • diagnosis of neuromuscular, rheumatic, inflammatory diseases
  • malignancy
  • uncontrollled systemic conditions
  • infections
  • trauma
  • neck surgery
  • pregnancy
  • obesity (BMI≥ 30 kg/m2).

Sites / Locations

  • Duygu Külcü

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Kinesiotaping (KT) with EDF technique

Sham Kinesiotaping

Arm Description

the patients were seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side while the shoulder was adducted. I band was first fold in half and then divided into 5 lines without cutting the ends to form a web shape. Two pieces of web shaped 20-25 cm length KT were used. The end of the KT was applied to the acromion, and the spinal process of C7 vertebra without stretching, but the web on the muscle had %10-15 tension. The second web shaped band was applied using the same technique between acromion and thoracal vertebral insertion of the middle trapezius muscle. Kinesio tape was planned to stay on for five days; it was applied twice, with two days of rest between applications Trapezius stretching exercises were given to patients as home exercise program.

The sham group received improper KT application consisting two I strips (same material as the real application) applied with no tension on c7 spinal process as cross sign. For sham taping, the cervical spine of the participants was placed in a neutral position. Kinesio tape was planned to stay on for five days; it was applied twice, with two days of rest between applications Trapezius stretching exercises were given to patients as home exercise program

Outcomes

Primary Outcome Measures

pain intensity
Visual Analog Scale: The Visual Analog Scale (VAS) (0-10 cm) was used to record each patient's current level of neck pain, with 0 indicating no pain and 10 indicating the worst pain that the patient had experienced.Higher scores mean worse outcome
number of active trigger points
number of active trigger points. Trigger points were determined manually by physical examination described by Travell and Simons.
cervical range of motion angles
measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine
Disability Level
Neck Pain Disability Scale: The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100. Higher scores mean worse outcome.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2022
Last Updated
June 16, 2022
Sponsor
Haydarpasa Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05405959
Brief Title
Kinesio Tape Application With EDF Technique on Active Trigger Points of Upper Trapezius Muscle
Official Title
Efficacy of Kinesio Tape Application With Epidermis Dermis Fascia (EDF) Technique in Patients With Active Myofascial Trigger Points in Upper Trapezius Muscle, a Prospective, Double Blinded Sham Controlled Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haydarpasa Numune Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
In this double-blinded, prospective randomized sham controlled multi centered study, the aim was to investigate the efficacy of EDF technique on pain intensity, number of active TrPs, cervical ROM and disability levels in patients with MPS on upper trapezius (UT) muscle.180 patients were randomly allocated to kinesio taping (KT) group or sham group. Applications were done two times 1 week apart. VAS-pain scores, disability scores , cervical ROM angles and number of trigger points were evaluated as outcome parameters. Vas-pain scores and number of trigger points were assessed at baseline, after 1 week and after 2 weeks (at the end of the study). Cervical ROM angles and disability (measured by Neck Pain Disability Scale) were assessed at baseline and at the end of the study. Both groups received home exercise program. As a result application of KT with EDF technique to the UT muscle provided a significant improvement in pain level, disability, number of active TrPs and cervical ROM angles and found superior to sham application.
Detailed Description
In order to determine the sample size, power analysis was performed using the G*Power Version 3.1.9.2 program. Effect size of 1.26 was set up for the VAS pain score changes between groups as per the previous study. For power calculations, a confidence level (α) of 0.05 and a power level of 0.95 was assumed. Fifteen patients per group in each center was required. 15 patients were randomized to two groups in each center by numbered envelopes method. The group 1 and group 2 notes were put into to the closed envelopes separately, and each patient randomly chose an envelope and gave it to a physician who was not the researcher. One researcher evaluated the patient and then collected the data, and the second researcher who was certified as KT practitioner applied the KT. Both patients and the researcher who recorded the data were blinded to treatment allocation.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Kinesiotaping (KT) with EDF technique
Arm Type
Experimental
Arm Description
the patients were seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side while the shoulder was adducted. I band was first fold in half and then divided into 5 lines without cutting the ends to form a web shape. Two pieces of web shaped 20-25 cm length KT were used. The end of the KT was applied to the acromion, and the spinal process of C7 vertebra without stretching, but the web on the muscle had %10-15 tension. The second web shaped band was applied using the same technique between acromion and thoracal vertebral insertion of the middle trapezius muscle. Kinesio tape was planned to stay on for five days; it was applied twice, with two days of rest between applications Trapezius stretching exercises were given to patients as home exercise program.
Arm Title
Sham Kinesiotaping
Arm Type
Sham Comparator
Arm Description
The sham group received improper KT application consisting two I strips (same material as the real application) applied with no tension on c7 spinal process as cross sign. For sham taping, the cervical spine of the participants was placed in a neutral position. Kinesio tape was planned to stay on for five days; it was applied twice, with two days of rest between applications Trapezius stretching exercises were given to patients as home exercise program
Intervention Type
Device
Intervention Name(s)
Kinesio tape
Intervention Description
The Kinesio Tex Gold FP (Kinesio Tex Tape, Kinesio Holding Corporation, Albuquerque, NM, USA) was used. It was waterproof, porous and adhesive, had a width of 5 cm and a thickness of 0.5 mm. The same brand of tape was used in both groups.
Intervention Type
Device
Intervention Name(s)
Sham Kinesio Tape
Intervention Description
The Kinesio Tex Gold FP (Kinesio Tex Tape, Kinesio Holding Corporation, Albuquerque, NM, USA) was used. It was waterproof, porous and adhesive, had a width of 5 cm and a thickness of 0.5 mm. The same brand of tape was used in both groups.
Primary Outcome Measure Information:
Title
pain intensity
Description
Visual Analog Scale: The Visual Analog Scale (VAS) (0-10 cm) was used to record each patient's current level of neck pain, with 0 indicating no pain and 10 indicating the worst pain that the patient had experienced.Higher scores mean worse outcome
Time Frame
Change from baseline at 2nd week
Title
number of active trigger points
Description
number of active trigger points. Trigger points were determined manually by physical examination described by Travell and Simons.
Time Frame
Change from baseline at 2nd week
Title
cervical range of motion angles
Description
measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine
Time Frame
Change from baseline at 2nd week
Title
Disability Level
Description
Neck Pain Disability Scale: The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100. Higher scores mean worse outcome.
Time Frame
Change from baseline at 2nd week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria: presence of an at least one active TrP and palpable taut band in the UT muscle pain duration less than 3 months pain Visual Analog Score VAS≥4 being between 18 and 50 years of age The exclusion criteria: diagnosis of neuromuscular, rheumatic, inflammatory diseases malignancy uncontrollled systemic conditions infections trauma neck surgery pregnancy obesity (BMI≥ 30 kg/m2).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Külcü, prof
Organizational Affiliation
Haydarpaşa Numune Edutation and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arzu Dinç
Organizational Affiliation
Medipol University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Belgin Erhan
Organizational Affiliation
Medeniyet University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Birkan Sonel Tur
Organizational Affiliation
Ankara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gül Tuğba Bulut
Organizational Affiliation
Istanbul E%R Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kamil Yazıcıoğlu
Organizational Affiliation
Güven Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zeynep Alpoğuz
Organizational Affiliation
Ankara State Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elif Çiğdem Keleş
Organizational Affiliation
Yeditepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Figen Ayhan
Organizational Affiliation
Uşak University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pınar Borman
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Merve Soysal
Organizational Affiliation
Ankara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bahar Çakmak
Organizational Affiliation
Bakırköy Sadi Konuk Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Duygu Külcü
City
İstanbul
State/Province
Ataşehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kinesio Tape Application With EDF Technique on Active Trigger Points of Upper Trapezius Muscle

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