NCT06012305

Brief Summary

Myofascial pain is a concept that refers to pain from trigger points. The region of the upper trapezius muscle is the most common region of myofascial pain syndrome (MAS). It is known that MAS is associated with disruptions in the fascia. It has been observed that kinesio taping supports healing by increasing the epidermal dermal distance. It is thought that the EDF (Epidermis Dermis Fascia) technique provides this effect on the fascia. This idea needs to be put forward with objective data and the study was designed for this purpose. It has been observed that kinesio taping with the inhibition technique for the upper trapezius trigger point has a positive effect on pain and function. Therefore, it will be investigated whether the EDF technique and the inhibition technique have any advantages over each other. An exercise program will be applied to all three groups in the study design, so whether taping provides an additional benefit to fascia smoothness, pain and function will be examined and the 4-week long-term effect of taping, which is mostly short-term effect, will be revealed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

August 17, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

Athletic TapeTrigger Points

Outcome Measures

Primary Outcomes (1)

  • Evaluation of fascia stiffness by shear wave elastography

    The device provides information on hardness by measuring the velocity of shear waves. The transducer probe of the device will be placed on the tight band in the upper trapezius detected by palpation, and after a comfortable expiration, an image will be taken from the region while the person is sitting. It is planned to take 3 images at 10 second intervals. The acquired image presents both quantitative and qualitative data. Shear modulus values of 10x10 mm square images taken on the trigger point will provide objective data on hardness.

    Three measurements at once at the beginning and end of 4 weeks, measurement time 5 minutes per session

Secondary Outcomes (4)

  • Measurement of pain pressure threshold with an algometer

    Three measurements at once at the beginning and end of 4 weeks, measurement time 5 minutes per session

  • Pain Assessment with Visual Analog Scale

    One measurement at the beginning and end of 4 weeks, 30 seconds measurement time per session

  • Evaluation of upper extremity functions

    The questionnaire will be administered at the beginning and end of 4 weeks. The application time of the questionnaire is approximately 5 minutes.

  • Neck Disability Index

    The questionnaire will be administered at the beginning and end of 4 weeks. The application time of the questionnaire is approximately 5 minutes.

Study Arms (3)

Only Exercise Group

NO INTERVENTION

They will be included in the exercise program that includes postural exercises after ischemic compression and stretching. Stretching exercises will be aimed at stretching the upper trapezius muscle. In the sitting position, the person whose head will be flexed and lateral flexed to the opposite side will stay in this position for 30 seconds and then come back to the same position. This will be practiced 15 times a day, 3 days a week. Ischemic compression will then be applied. In ischemic compression, the therapist will apply pressure on the trigger points detected by palpation for 1 minute, and the application will be completed with a total of 5 repetitions at 1-minute intervals. It will continue to be applied 3 sets a day, 3 days a week. Posture exercises were determined as scapular retraction and chin tuck exercises. The exercises will be done in 3 sets of 15 repetitions per day, 3 days a week.

Taping Group with Muscle Technique

ACTIVE COMPARATOR

In addition to the exercise program in the first group, upper trapezius inhibition tape will be applied on the myofascial trigger points in the upper trapezius 3 times a week. The KT (Kinesio Tex Tape, Kinesio Holding Corporation, Albuquerque, USA) used in this study will be waterproof, porous and adhesive. 5 cm wide and 0.5 mm thick kinesio tape will be used. Before the application, the patient will be seated and asked to bring the neck to the opposite side lateral flexion and the head to the same side rotation. In this position, the Kinesiotape inhibition technique will be applied. The tape will be asked to stay on the person for 2 days, then it will be interrupted for 1 day and then the same application will be made. This practice will continue during the 4 weeks of treatment.

Other: Taping

Taping Group with Epidermis Dermis Fascia Technique

EXPERIMENTAL

In addition to the exercise program in the first group, kinesio taping will be applied with web cut cutting with EDF technique on myofascial trigger points in the upper trapezius. Before the application, the patient will be seated and asked to bring the neck to the opposite side lateral flexion and the head to the same side rotation. Tape will be applied with EDF technique. The band will be asked to stay on the person for 2 days, then a break for 1 day and then the same application will be made again. This practice will continue during the 4 weeks of treatment.

Other: Taping

Interventions

TapingOTHER

Taping has the effect of accelerating the flow in the tissue by increasing the epidermal dermal distance. The muscle technique used in the study will be applied to the trapezius muscle and aims to reduce the working level of the muscle. The EDF technique, which will be used in another group, aims to create a stronger base taping effect.

Also known as: Exercise, ischemic compression
Taping Group with Epidermis Dermis Fascia TechniqueTaping Group with Muscle Technique

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Having a diagnosis of fibromyalgia syndrome, diagnosis of psychiatric disorders such as anxiety and depression, radiculopathy symptoms, brachial plexopathy or other nerve entrapments, treatment for myofascial pain syndrome in the last six months, having a malignancy, being pregnant, having an infectious disease, having an inflammatory musculoskeletal system disease have had shoulder or neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Eyalet/Yerleşke, 06300, Turkey (Türkiye)

Location

Related Publications (6)

  • Quintner JL, Bove GM, Cohen ML. A critical evaluation of the trigger point phenomenon. Rheumatology (Oxford). 2015 Mar;54(3):392-9. doi: 10.1093/rheumatology/keu471. Epub 2014 Dec 3.

  • Ertekin E, Kasar ZS, Turkdogan FT. Is early diagnosis of myofascial pain syndrome possible with the detection of latent trigger points by shear wave elastography? Pol J Radiol. 2021 Jul 12;86:e425-e431. doi: 10.5114/pjr.2021.108537. eCollection 2021.

  • Celiker R, Atalay A, Guven Z. Health-related quality of life in patients with myofascial pain syndrome. Curr Pain Headache Rep. 2010 Oct;14(5):361-6. doi: 10.1007/s11916-010-0141-7.

  • Kafa N, Citaker S, Omeroglu S, Peker T, Coskun N, Diker S. Effects of kinesiologic taping on epidermal-dermal distance, pain, edema and inflammation after experimentally induced soft tissue trauma. Physiother Theory Pract. 2015;31(8):556-61. doi: 10.3109/09593985.2015.1062943.

  • Akpinar FM, Sindel D, Ketenci A. Investigation of Effectiveness of Two Different Kinesiotaping Techniques in Myofascial Pain Syndrome: An Open-Label Randomized Clinical Trial. Pain Physician. 2021 Sep;24(6):E721-E731.

  • Dilek B, Batmaz I, Akif Sariyildiz M, Sahin E, Bulut D, Akalin E, Cevik R, Nas K. Effectiveness of training about kinesiotaping in myofascial pain syndrome: A prospective, single-blind, randomized-controlled study. Turk J Phys Med Rehabil. 2021 Mar 4;67(1):17-24. doi: 10.5606/tftrd.2021.4258. eCollection 2021 Mar.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

ExerciseAcupressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person who will make the assessments will not know in which group the individual he/she is assessing is in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In the study, there were three groups in which three different treatment programs were applied.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 25, 2023

Study Start

December 10, 2023

Primary Completion

February 15, 2024

Study Completion

November 15, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations