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

NCT ID: NCT05405959

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2019-09-01

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.

Conditions

Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Kinesio tape

Intervention Type: DEVICE

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 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

Group Type: SHAM_COMPARATOR

Sham Kinesio Tape

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Duygu Geler Külcü

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duygu Külcü, prof

Role: PRINCIPAL_INVESTIGATOR

Haydarpaşa Numune Edutation and Research Hospital

Arzu Dinç

Role: STUDY_DIRECTOR

Medipol University

Belgin Erhan

Role: STUDY_CHAIR

Medeniyet University

Birkan Sonel Tur

Role: STUDY_CHAIR

Ankara University

Gül Tuğba Bulut

Role: STUDY_CHAIR

Istanbul E%R Hospital

Kamil Yazıcıoğlu

Role: STUDY_CHAIR

Güven Hospital

Zeynep Alpoğuz

Role: STUDY_CHAIR

Ankara State Hospital

Elif Çiğdem Keleş

Role: STUDY_CHAIR

Yeditepe University

Figen Ayhan

Role: STUDY_CHAIR

Uşak University

Pınar Borman

Role: STUDY_CHAIR

Hacettepe University

Merve Soysal

Role: STUDY_CHAIR

Ankara University

Bahar Çakmak

Role: STUDY_CHAIR

Bakırköy Sadi Konuk Education and Research Hospital

Locations

Duygu Külcü

Istanbul, Ataşehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HNEAH-KAEK 2017/109

Identifier Type: -

Identifier Source: org_study_id