A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Early Phase 1
Locations
Poland
Study Type
Interventional
Intervention
MD Muscle GUNA collagen
Lidocaine 2% Injectable Solution
Saline Solution, Hypertonic
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder focused on measuring TMD, collagen, intramuscular injection, trigger point
Eligibility Criteria
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
Sites / Locations
- Department of TMD and Orthodontics Silesian Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MD Muscle Collagen group
Lidocaine 2% group
Saline
Arm Description
Group with collagen intramuscular injections
Group with 2% Lidocaine intramuscular injections
Group with 0,9% NaCl intramuscular injections
Outcomes
Primary Outcome Measures
sEMG reduction of masseter muscle in TMD patients
reduction of electromyograpic activity of masseter muscle
Secondary Outcome Measures
Full Information
NCT ID
NCT03323567
First Posted
October 24, 2017
Last Updated
January 2, 2018
Sponsor
Medical University of Silesia
1. Study Identification
Unique Protocol Identification Number
NCT03323567
Brief Title
A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
Official Title
A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (undefined)
Primary Completion Date
October 4, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
TMD, collagen, intramuscular injection, trigger point
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
patients were divided into the three groups and examination and therapy was performed after 7 and 14 days
Masking
ParticipantCare Provider
Masking Description
Participants and care providers had no knowledge about the substance prepared for the injection. The information for the main investigator was the number of patient and the number of injection
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MD Muscle Collagen group
Arm Type
Experimental
Arm Description
Group with collagen intramuscular injections
Arm Title
Lidocaine 2% group
Arm Type
Experimental
Arm Description
Group with 2% Lidocaine intramuscular injections
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Group with 0,9% NaCl intramuscular injections
Intervention Type
Drug
Intervention Name(s)
MD Muscle GUNA collagen
Other Intervention Name(s)
intramuscular MD Muscle collagen injection
Intervention Description
intramusclular injections of MD Muscle collagen
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Other Intervention Name(s)
intramuscular Lidocaine 2% injection
Intervention Description
intramuscular Lidocaine 2% injection
Intervention Type
Drug
Intervention Name(s)
Saline Solution, Hypertonic
Other Intervention Name(s)
intramuscular Saline injection
Intervention Description
intramuscular Saline injection
Primary Outcome Measure Information:
Title
sEMG reduction of masseter muscle in TMD patients
Description
reduction of electromyograpic activity of masseter muscle
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of TMD and Orthodontics Silesian Medical University
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26491094
Citation
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Results Reference
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PubMed Identifier
3343629
Citation
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Results Reference
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PubMed Identifier
3992061
Citation
Lehto M, Sims TJ, Bailey AJ. Skeletal muscle injury--molecular changes in the collagen during healing. Res Exp Med (Berl). 1985;185(2):95-106. doi: 10.1007/BF01854894.
Results Reference
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PubMed Identifier
9338413
Citation
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Results Reference
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PubMed Identifier
26377767
Citation
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Results Reference
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PubMed Identifier
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Citation
Nitecka-Buchta A, Walczynska-Dragon K, Kempa WM, Baron S. Platelet-Rich Plasma Intramuscular Injections - Antinociceptive Therapy in Myofascial Pain Within Masseter Muscles in Temporomandibular Disorders Patients: A Pilot Study. Front Neurol. 2019 Mar 19;10:250. doi: 10.3389/fneur.2019.00250. eCollection 2019.
Results Reference
derived
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A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
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