NCT04827303

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 29, 2021

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • The number of trigger points

    The number of trigger points was determined by the physician by hand palpation.

    1 week

  • Pressure pain threshold

    Pressure pain threshold was evaluated with the algometer device.

    1 week

  • Neck pain disability index

    Disability assessment of the patients was made using the neck pain disability index.

    1 week

Interventions

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.

Also known as: trigger point injection, neural therapy injection

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Patients diagnosed with acute myofascial pain syndrome
  • Patients between the ages of 20-50
  • Patients with pain for up to 5 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • saime ay

    Ufuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations