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

Overview

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.

Full Title of Study: “A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 4, 2017

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%.

Interventions

  • Drug: MD Muscle GUNA collagen
    • intramusclular injections of MD Muscle collagen
  • Drug: Lidocaine 2% Injectable Solution
    • intramuscular Lidocaine 2% injection
  • Drug: Saline Solution, Hypertonic
    • intramuscular Saline injection

Arms, Groups and Cohorts

  • Experimental: MD Muscle Collagen group
    • Group with collagen intramuscular injections
  • Experimental: Lidocaine 2% group
    • Group with 2% Lidocaine intramuscular injections
  • Placebo Comparator: Saline
    • Group with 0,9% NaCl intramuscular injections

Clinical Trial Outcome Measures

Primary Measures

  • sEMG reduction of masseter muscle in TMD patients
    • Time Frame: 14 days
    • reduction of electromyograpic activity of masseter muscle

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Silesia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aleksandra Nitecka-Buchta, Principal Investigator D.M.D. PhD – Medical University of Silesia

References

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.

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.

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.

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.

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.

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