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

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405959
• Other study ID #: HNEAH-KAEK 2017/109
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: June 2022
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain

Intervention

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 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.

Locations

Country	Name	City	State
Turkey	Duygu Külcü	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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