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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827303
Other study ID # 29032017-8
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date April 1, 2019

Study information

Verified date March 2021
Source Ufuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a randomized controlled study. A total of 75 patients between the ages of 20-50 who have a diagnosis of acute myofacial pain syndrome in the trapezius muscle and have pain for a maximum of 5 days were included in the study. Patients were randomly divided into 3 groups. Group 1 patients received kinesio tape method (25 patients), group 2 patients received trigger point injection method (25 patients), and group 3 patients received neural therapy injection method (25 patients). A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications. The pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (VAS 10 cm). The number of trigger points was determined by the physician by hand palpation. Pressure pain threshold was evaluated with the algometer device. Disability assessment of the patients was made using the neck pain disability index. evaluations were made at the beginning of treatment, 72 hours after and 1 week after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients diagnosed with acute myofascial pain syndrome - Patients between the ages of 20-50 - Patients with pain for up to 5 days Exclusion Criteria: - Patients diagnosed with fibromyalgia - Patients with systemic disease - Patients with prominent cervical disc herniation - Patients with cervical arthrosis - Patients with cervical radiculopathy and myelopathy - Patients with myofascial trigger point injection in the past 6 months - Patients who received physical therapy in the past 6 months - Patients undergoing shoulder and neck surgery - Patients with drug allergies

Study Design


Intervention

Other:
Kinesio taping
A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications.

Locations

Country Name City State
Turkey Ufuk University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale The pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (VAS 10 cm). 1 week
Primary The number of trigger points The number of trigger points was determined by the physician by hand palpation. 1 week
Primary Pressure pain threshold Pressure pain threshold was evaluated with the algometer device. 1 week
Primary Neck pain disability index Disability assessment of the patients was made using the neck pain disability index. 1 week
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