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

H

Haydarpasa Numune Training and Research Hospital

Status

Completed

Conditions

Myofascial Trigger Point Pain
Myofascial Pain Syndrome

Treatments

Device: Sham Kinesio Tape
Device: Kinesio tape

Study type

Interventional

Funder types

Other

Identifiers

NCT05405959
HNEAH-KAEK 2017/109

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups

Kinesiotaping (KT) with EDF technique
Experimental group
Description:
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.
Treatment:
Device: Kinesio tape
Sham Kinesiotaping
Sham Comparator group
Description:
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
Treatment:
Device: Sham Kinesio Tape

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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