Skip to content

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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03323567
Enrollment
43
Registered
2017-10-27
Start date
2016-01-10
Completion date
2017-10-12
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder

Keywords

TMD, collagen, intramuscular injection, trigger point

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%.

Interventions

DRUGSaline Solution, Hypertonic

intramuscular Saline injection

DRUGMD Muscle GUNA collagen

intramusclular injections of MD Muscle collagen

intramuscular Lidocaine 2% injection

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sEMG reduction of masseter muscle in TMD patients14 daysreduction of electromyograpic activity of masseter muscle

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026