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

NCT05405959 | Completed

• 1 other identifier: HNEAH-KAEK 2017/109
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Kinesiotaping (KT) with EDF technique

EXPERIMENTAL

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.

Device: Kinesio tape

Sham Kinesiotaping

SHAM COMPARATOR

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

Device: Sham Kinesio Tape

Interventions

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.

Kinesiotaping (KT) with EDF technique

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.

Sham Kinesiotaping

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• diagnosis of neuromuscular, rheumatic, inflammatory diseases
• malignancy
• uncontrollled systemic conditions
• infections
• trauma
• neck surgery
• pregnancy
• obesity (BMI≥ 30 kg/m2).

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Duygu Külcü

Istanbul, Ataşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Duygu Külcü, prof

  Haydarpaşa Numune Edutation and Research Hospital

  PRINCIPAL INVESTIGATOR

• Arzu Dinç

  Medipol University

  STUDY DIRECTOR

• Belgin Erhan

  Medeniyet University

  STUDY CHAIR

• Birkan Sonel Tur

  Ankara University

  STUDY CHAIR

• Gül Tuğba Bulut

  Istanbul E%R Hospital

  STUDY CHAIR

• Kamil Yazıcıoğlu

  Güven Hospital

  STUDY CHAIR

• Zeynep Alpoğuz

  Ankara State Hospital

  STUDY CHAIR

• Elif Çiğdem Keleş

  Yeditepe University

  STUDY CHAIR

• Figen Ayhan

  Uşak University

  STUDY CHAIR

• Pınar Borman

  Hacettepe University

  STUDY CHAIR

• Merve Soysal

  Ankara University

  STUDY CHAIR

• Bahar Çakmak

  Bakırköy Sadi Konuk Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 6, 2022
• Study Start: January 2, 2019
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)