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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain

• Registration Number: NCT05405959
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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.

Study Timeline

• Study Start: 2019-01-02
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01
• Study First Submitted: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of active trigger points	Change from baseline at 2nd week	number of active trigger points. Trigger points were determined manually by physical examination described by Travell and Simons.
cervical range of motion angles	Change from baseline at 2nd week	measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine
Disability Level	Change from baseline at 2nd week	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.
pain intensity	Change from baseline at 2nd week	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

Trial Locations

Locations (1)

Duygu Külcü; 🇹🇷 İstanbul, Ataşehir, Turkey