Clinical Trials Directory

Trials / Completed

CompletedNCT05405959

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Haydarpasa Numune Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEKinesio tapeThe 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.
DEVICESham Kinesio TapeThe 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.

Timeline

Start date
2019-01-02
Primary completion
2019-04-01
Completion
2019-09-01
First posted
2022-06-06
Last updated
2022-06-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05405959. Inclusion in this directory is not an endorsement.