A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.

January 2, 2018 updated by: Aleksandra Nitecka-Buchta, Medical University of Silesia

A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.

An intramusclular injection of three solutions were performed( collagen, lidocaine, saline) in musculoskeletal trigger points, in patients suffering from temporomandibular disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Collagen is an important component, building myocytes and extracellular matrix of skeletal muscles. The novel treatment option for trigger point therapy and muscle regeneration in TMD patients are intramuscular collagen injections. The aim of the study was to evaluate the efficacy of intramuscular injections of Collagen MD Muscle(Guna) 2 ml, 2 ml of Lidocainum 2% without vasoconstrictor and 2 ml of Saline (0,9 % NaCl). 43 patients were enrolled to the study (17 male and 26 female, 40 +/- 3,8 years old). The masseter muscle activity was measured with sEMG Neurobit Optima 4 (Neurobit System). Visual Analogue Scale was used to determine pain intensity changes between follow-up visits in each group. Trigger points were localized with palpation of masseter muscle. Electromyographic activity of masseter muscle was measured before injections on each visit: 0, 7,14 days. In our analysis sEMG masseter muscle activity was significantly decreased: in collagen group 59,2%, in lidocainum group 39,3% and in saline group14%. Pain intensity reduction in VAS scale was 53,75% in collagen group, in lidocainum group 25% and in saline group 20,1%.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Department of TMD and Orthodontics Silesian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral

Exclusion Criteria:

  • younger than 18years old, active orthodonctic treatment,neurological treatment, post radiotherapy, after head trauma within 2 years, patients with unsupported occlusal contacts, addicted to analgesic drugs, with the fear of needle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MD Muscle Collagen group
Group with collagen intramuscular injections
Drug: MD Muscle GUNA collagen
intramusclular injections of MD Muscle collagen
Other Names:
  • intramuscular MD Muscle collagen injection
Experimental: Lidocaine 2% group
Group with 2% Lidocaine intramuscular injections
Drug: Lidocaine 2% Injectable Solution
intramuscular Lidocaine 2% injection
Other Names:
  • intramuscular Lidocaine 2% injection
Placebo Comparator: Saline
Group with 0,9% NaCl intramuscular injections
Drug: Saline Solution, Hypertonic
intramuscular Saline injection
Other Names:
  • intramuscular Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sEMG reduction of masseter muscle in TMD patients
Time Frame: 14 days
reduction of electromyograpic activity of masseter muscle
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 10, 2016

Primary Completion (Actual)

October 4, 2017

Study Completion (Actual)

October 12, 2017

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silesian UM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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