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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06012305
Other study ID # GaziosmanpasaU-FTR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 10, 2023
Est. completion date November 15, 2024

Study information

Verified date December 2023
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Myofascial pain is a concept that refers to pain from myofascial trigger points. Certain small, hardened, tender areas in the muscle that can be identified by palpation are called trigger points. The upper trapezius is the most common area of myofascial pain syndrome. Working at a desk for a long time and doing intense overhead activities are among the important reasons for this. Individuals who experience myofascial pain with an upper trapezius trigger point are adversely affected in many ways professionally and socially. The pathophysiological process that causes this pain is also related to fascia involvement. It is thought that a taping application that will provide a corrective effect on the fascia will reduce myofascial pain symptoms. The study was designed with the aim of demonstrating that it provides this with objective data. Kinesio taping increases the epidermal-dermal distance and provides an effect that accelerates the healing after injury. It has been widely preferred in our country and in other countries before, and there is literature support that it can be used safely. It is seen that the inhibition technique is frequently preferred when taping is used in the presence of an upper trapezius trigger point. It is thought that trigger point symptoms will be reduced by inhibiting the upper trapezius muscle to a certain extent with this technique, and some studies in which this effect is achieved are included in the literature. Another taping technique, the Epidermis Dermis Fascia technique (EDF), has been reported to have a healing effect on fascia as clinical opinion, but there is a lack of evidence in the relevant literature. At the end of the study, the answers to the questions of whether the inhibition technique, which is one of the frequently used techniques, or the epidermis dermis fascia technique, which is at the forefront with its effect on fascia, will be more effective on fascia smoothness, pain and function will be found. With the provision of fascia correction, it is aimed to reduce pain and increase function. It is thought that these gains will reduce the negative effects of myofascial pain. In addition to taping, two groups will be given an exercise program with proven effect of reducing pain and increasing function in myofascial pain syndrome. The program will include ischemic compression and posture exercises. The aspects that have not been revealed in previous studies and are considered to be deficiencies are as follows: Which tape technique should be used, which one can be more beneficial? In which of the parameters of pain, function and fascia smoothness will the benefit be valid? What is the long-term effect of kinesio taping, which has a pain-reducing and function-enhancing effect in the short term?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date November 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Patients with a differential diagnosis of myofascial pain syndrome with unilateral or bilateral active trigger points in the upper trapezius muscle will be included in the study. The criteria for trigger point detection are stated in the literature as follows: 1) The muscle has a challenging palpation area (this area is called the taut band) 2) The trigger point with localized sensitivity in the taut band 3) Typical pain when continuous pressure is applied to the trigger point in the taut band. , numbness, tingling, 4) Local twitching response when the taut band is bent horizontally. Other inclusion criteria are: 18-50 years of age, more than two weeks of symptom duration Exclusion Criteria: - 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

Study Design


Intervention

Other:
Taping
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.

Locations

Country Name City State
Turkey Tokat Gaziosmanpasa University Tokat Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Measurement of pain pressure threshold with an algometer An analog algometer will be used. The device has a disc-shaped rubber tip with a surface area of exactly 1 cm2. Pressure measurements are expressed in kilograms per square centimeter (kg/cm2). Algometer, metal rod will be perpendicular to the skin surface and the patient will sit; Pressure will be applied to the determined trigger point in 1 kg/second increments. The patient will be instructed to indicate the last point at which pain was perceived. After the dial is set to zero, the process will be repeated 3 times for each patient at 1 minute intervals. The average of three readings will be used for analysis. The dial will show a value between 0 and 22. 0 represents the lowest point of the pain threshold, 22 the highest point. Three measurements at once at the beginning and end of 4 weeks, measurement time 5 minutes per session
Secondary Pain Assessment with Visual Analog Scale It will be used in two separate pain evaluations for the upper trapezius region and the pain radiating to the neck and back. 0 will indicate no pain, and ten will show the worst pain the patient has ever experienced. Values will be obtained along a 10 cm Visual Analog Scale line using a ruler marked in centimeters. One measurement at the beginning and end of 4 weeks, 30 seconds measurement time per session
Secondary Evaluation of upper extremity functions The short version of the Arm, Shoulder, and Hand Problems Questionnaire(DASH) will be used to make this assessment. DASH is a 30-item questionnaire designed to assess musculoskeletal disorders of the upper extremities. At least 27 questions must be completed for scoring. DASH scores range from 0 to 100, with higher scores indicating a higher level of disability. DASH has been reported to be a valid and reliable tool for evaluating various arm functions. There is information in the literature that Quick DASH, which is its short version, can also provide information about upper extremity function in correlation with DASH. Turkish validity and reliability study was conducted. The questionnaire will be administered at the beginning and end of 4 weeks. The application time of the questionnaire is approximately 5 minutes.
Secondary Neck Disability Index Vernon and Mion designed the Neck Disability Index (NDI) to assess how neck pain affects activities of daily living. There is a Turkish validity and reliability study. A score between 0 and 50 points can be obtained from the scale. 0 points means no disability, 50 points means very severe disability. The questionnaire will be administered at the beginning and end of 4 weeks. The application time of the questionnaire is approximately 5 minutes.
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