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

NCT03323567 | Completed Early Phase 1

• 1 other identifier: Silesian UM
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Keywords

TMD, collagen, intramuscular injection, trigger point

Outcome Measures

Primary Outcomes (1)

• sEMG reduction of masseter muscle in TMD patients

  reduction of electromyograpic activity of masseter muscle

  14 days

Study Arms (3)

MD Muscle Collagen group

EXPERIMENTAL

Group with collagen intramuscular injections

Drug: MD Muscle GUNA collagen

Lidocaine 2% group

EXPERIMENTAL

Group with 2% Lidocaine intramuscular injections

Drug: Lidocaine 2% Injectable Solution

Saline

PLACEBO COMPARATOR

Group with 0,9% NaCl intramuscular injections

Drug: Saline Solution, Hypertonic

Interventions

MD Muscle GUNA collagen DRUG

intramusclular injections of MD Muscle collagen

Also known as: intramuscular MD Muscle collagen injection

MD Muscle Collagen group

Lidocaine 2% Injectable Solution DRUG

intramuscular Lidocaine 2% injection

Also known as: intramuscular Lidocaine 2% injection

Lidocaine 2% group

Saline Solution, Hypertonic DRUG

intramuscular Saline injection

Also known as: intramuscular Saline injection

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of TMD and Orthodontics Silesian Medical University

Zabrze, 41-800, Poland

Location

Related Publications (6)

• Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.

  PMID: 26491094 BACKGROUND

• Jarvholm U, Palmerud G, Styf J, Herberts P, Kadefors R. Intramuscular pressure in the supraspinatus muscle. J Orthop Res. 1988;6(2):230-8. doi: 10.1002/jor.1100060210.

  PMID: 3343629 BACKGROUND

• 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.

  PMID: 3992061 BACKGROUND

• Sorichter S, Mair J, Koller A, Gebert W, Rama D, Calzolari C, Artner-Dworzak E, Puschendorf B. Skeletal troponin I as a marker of exercise-induced muscle damage. J Appl Physiol (1985). 1997 Oct;83(4):1076-82. doi: 10.1152/jappl.1997.83.4.1076.

  PMID: 9338413 BACKGROUND

• Cescon M, Gattazzo F, Chen P, Bonaldo P. Collagen VI at a glance. J Cell Sci. 2015 Oct 1;128(19):3525-31. doi: 10.1242/jcs.169748. Epub 2015 Sep 16.

  PMID: 26377767 BACKGROUND

• 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.

  PMID: 30941095 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Lidocaine; Injections; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator D.M.D. PhD

Model Details: patients were divided into the three groups and examination and therapy was performed after 7 and 14 days

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: January 10, 2016
• Primary Completion: October 4, 2017
• Study Completion: October 12, 2017
• Last Updated: January 4, 2018

Record last verified: 2018-01

Locations

PL (1)