Temporomandibular DisorderEarly Phase 1NCT03323567
A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
A Early Phase 1 study testing MD Muscle GUNA collagen, Lidocaine 2% Injectable Solution and Saline Solution, Hypertonic in people with Temporomandibular Disorder, run by Medical University of Silesia at 1 site in Poland.
Trial summary
An intramusclular injection of three solutions were performed( collagen, lidocaine, saline) in musculoskeletal trigger points, in patients suffering from temporomandibular disorders(TMD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- MD Muscle GUNA collagen, Lidocaine 2% Injectable Solution and Saline Solution, Hypertonic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2016to 12 Oct 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of TMD and Orthodontics Silesian Medical University
Zabrze, 41-800
About this study
Official title: 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.
Read the 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%.
- Conditions
- Temporomandibular Disorder
- Being tested
- MD Muscle GUNA collagen, Lidocaine 2% Injectable Solution, Saline Solution, Hypertonic
- Keywords
- TMD, collagen, intramuscular injection, trigger point
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD Muscle GUNA collagenDrug
Also called intramuscular MD Muscle collagen injection
intramusclular injections of MD Muscle collagen
Lidocaine 2% Injectable SolutionDrug
Also called intramuscular Lidocaine 2% injection
intramuscular Lidocaine 2% injection
Saline Solution, HypertonicDrug
Also called intramuscular Saline injection
intramuscular Saline injection
| Study group | Role | What they receive |
|---|---|---|
| MD Muscle Collagen group | Experimental | Group with collagen intramuscular injections Receives: Drug: MD Muscle GUNA collagen |
| Lidocaine 2% group | Experimental | Group with 2% Lidocaine intramuscular injections Receives: Drug: Lidocaine 2% Injectable Solution |
| Saline | Placebo comparator | Group with 0,9% NaCl intramuscular injections Receives: Drug: Saline Solution, Hypertonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
sEMG reduction of masseter muscle in TMD patients
reduction of electromyograpic activity of masseter muscle
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start10 Jan 2016
- Primary completion4 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- patients were divided into the three groups and examination and therapy was performed after 7 and 14 days
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Nitecka-Buchta, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323567
- Sponsor's protocol ID
- Silesian UM
- Status last verified
- Jan 2018
- First submitted
- 24 Oct 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26491094Jarvholm 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.
PubMed 3343629Lehto 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.
PubMed 3992061Sorichter 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.
PubMed 9338413Cescon 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.
PubMed 26377767Nitecka-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.
PubMed 30941095
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.
- ClinicalTrials.gov ID
- NCT03323567
- Acronym / sponsor ID
- Silesian UM
- Conditions
- Temporomandibular Disorder
- Keywords
- TMD, collagen, intramuscular injection, trigger point
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 10 Jan 2016
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- patients were divided into the three groups and examination and therapy was performed after 7 and 14 days
| Arm | Type | Receives |
|---|---|---|
| MD Muscle Collagen group | Experimental | Drug: MD Muscle GUNA collagenGroup with collagen intramuscular injections |
| Lidocaine 2% group | Experimental | Drug: Lidocaine 2% Injectable SolutionGroup with 2% Lidocaine intramuscular injections |
| Saline | Placebo comparator | Drug: Saline Solution, HypertonicGroup with 0,9% NaCl intramuscular injections |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD Muscle GUNA collagenAlso: intramuscular MD Muscle collagen injectionintramusclular injections of MD Muscle collagen | Drug | MD Muscle Collagen group |
| Lidocaine 2% Injectable SolutionAlso: intramuscular Lidocaine 2% injectionintramuscular Lidocaine 2% injection | Drug | Lidocaine 2% group |
| Saline Solution, HypertonicAlso: intramuscular Saline injectionintramuscular Saline injection | Drug | Saline |
Primary outcome
sEMG reduction of masseter muscle in TMD patients
Time frame: 14 days
reduction of electromyograpic activity of masseter muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Background: PubMed 26491094Turo 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.
- Background: PubMed 3343629Jarvholm 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.
- Background: PubMed 3992061Lehto 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.
- Background: PubMed 9338413Sorichter 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.
- Background: PubMed 26377767Cescon 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.
- Derived from this study: PubMed 30941095Nitecka-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.
- Individual participant dataSharing planned: Undecided
Related trials for Temporomandibular Disorder
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MD Muscle GUNA collagen, Lidocaine 2% Injectable Solution and Saline Solution, Hypertonic in people with Temporomandibular Disorder, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sEMG reduction of masseter muscle in TMD patients (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323567, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.