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

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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain
• Intervention / Treatment: Device: Kinesio tape; Device: Sham Kinesio Tape

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ataşehir
    • İstanbul, Ataşehir, Turkey
      • Duygu Külcü

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinesiotaping (KT) with EDF technique; 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.	Device: Kinesio tape; 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.
Sham Comparator: Sham Kinesiotaping; 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	Device: Sham Kinesio Tape; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline at 2nd week
number of active trigger points	number of active trigger points. Trigger points were determined manually by physical examination described by Travell and Simons.	Change from baseline at 2nd week
cervical range of motion angles	measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine	Change from baseline at 2nd week
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.	Change from baseline at 2nd week

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital
• Investigators: Principal Investigator: Duygu Külcü, prof, Haydarpaşa Numune Edutation and Research Hospital; Study Director: Arzu Dinç, Medipol University; Study Chair: Belgin Erhan, MEDENIYET UNIVERSITY; Study Chair: Birkan Sonel Tur, Ankara University; Study Chair: Gül Tuğba Bulut, Istanbul E%R Hospital; Study Chair: Kamil Yazıcıoğlu, Guven Hospital; Study Chair: Zeynep Alpoğuz, Ankara State Hospital; Study Chair: Elif Çiğdem Keleş, Yeditepe University; Study Chair: Figen Ayhan, Uşak University; Study Chair: Pınar Borman, Hacettepe University; Study Chair: Merve Soysal, Ankara University; Study Chair: Bahar Çakmak, Bakırköy Sadi Konuk Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: HNEAH-KAEK 2017/109

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