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Completed

NCT Number: NCT05405959

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

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Myofascial Trigger Point Pain

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duygu Külcü

Istanbul, Ataşehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Kinesio Tape

Device

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

Device

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.

Primary outcomes

  1. pain intensity

    Time frame: 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

  2. number of active trigger points

    Time frame: Change from baseline at 2nd week

    number of active trigger points. Trigger points were determined manually by physical examination described by Travell and Simons.

  3. cervical range of motion angles

    Time frame: Change from baseline at 2nd week

    measured by goniometer for flexion, extension, left and right lateral flexion of cervical spine

  4. Disability Level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2022
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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