Clinical trial NCT05405959: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Myofascial Trigger Point Pain
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: pain intensity
timeFrame: Change from baseline at 2nd week
measure: number of active trigger points
timeFrame: Change from baseline at 2nd week
measure: cervical range of motion angles
timeFrame: Change from baseline at 2nd week
measure: Disability Level
timeFrame: Change from baseline at 2nd week
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Duygu Külcü
state: Ataşehir
Study officials:
affiliation: Haydarpaşa Numune Edutation and Research Hospital
name: Duygu Külcü, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Arzu Dinç
role: STUDY_DIRECTOR
affiliation: Medeniyet University
name: Belgin Erhan
role: STUDY_CHAIR
affiliation: Ankara University
name: Birkan Sonel Tur
role: STUDY_CHAIR
affiliation: Istanbul E%R Hospital
name: Gül Tuğba Bulut
role: STUDY_CHAIR
affiliation: Güven Hospital
name: Kamil Yazıcıoğlu
role: STUDY_CHAIR
affiliation: Ankara State Hospital
name: Zeynep Alpoğuz
role: STUDY_CHAIR
affiliation: Yeditepe University
name: Elif Çiğdem Keleş
role: STUDY_CHAIR
affiliation: Uşak University
name: Figen Ayhan
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Pınar Borman
role: STUDY_CHAIR
affiliation: Ankara University
name: Merve Soysal
role: STUDY_CHAIR
affiliation: Bakırköy Sadi Konuk Education and Research Hospital
name: Bahar Çakmak
role: STUDY_CHAIR
References: