Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study

NCT06677216 | Enrolling By Invitation

• 2 other identifiers: 23-061Wetenschapsbeurzen W2021-2001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the clinical course in terms of pain, function and quality of life of patients with TMD-related myalgia during six months after receiving BTX-A injections. The research question was: What are the outcomes in pain, quality of life and function of patients with TMD-related myalgia receiving BTX-A during 6 months? The hypothesis to be tested was that patients receiving a BTX-A injection due to TMD-related myalgia will have a reduction in pain and increase in quality of life and function after one, three- and six- months.

Conditions

TMD/Orofacial Pain; Myalgia of Mastication Muscle; Botulinum Toxin, Type a

Keywords

TMD; Myalgia; Orofacial pain; Botulinum Toxin A

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean pain rated with the VAS at 1, 3 and 6 months

  The VAS will be used to measure pain intensity. The VAS consists of a 100 mm line, with two set points, 0 (indicating no pain) and 10 (indicating worst imaginable pain).

  Baseline, 1, 3 and 6 months

Secondary Outcomes (3)

• Change from baseline in the mean oral health related quality of life rated with the OHIP-14 at 1, 3 and 6 months

  Baseline, 1, 3 and 6 months

• Change from baseline in mean mandibular function rated by the MFIQ at 1, 3, and 6 months

  Baseline, 1, 3 and 6 months

• Change from baseline in the mean maximal active and passive mouth opening at 1, 3 and 6 months

  Baseline, 1, 3 and 6 months

Study Arms (1)

Patients with TMD-related myalgia treated with BTX-A at the department of OMS

Participants for this study were adults with TMD-related myalgia according to the DC/TMD treated with a BTX-A injection. All participants were recruited at the department of Oral and Maxillofacial Surgery (OMS) of the Diakonessenhuis, Utrecht, The Netherlands.

Procedure: Botulinum Toxin, Type A

Interventions

Botulinum Toxin, Type A PROCEDURE

All participants will receive a solution of BTX-A (Xeomin, Merz Pharma GmbH, Frankfurt am Main, Germany) in the masseter and temporalis muscles (total of 100 units reconstituted with 4cc unpreserved 0.9% sodium chloride). The injection will be provided by the same maxillofacial surgeon. The participants are asked to clench their teeth to determine the site of the most intense muscle activity in the masseter and temporal muscles with palpation. Intramuscular BTX-A injections are administered on both sides at the location of the most intense muscle activity of the masseter (80 units) and temporalis (20 units).

Patients with TMD-related myalgia treated with BTX-A at the department of OMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for this study were adults with TMD-related myalgia according to the DC/TMD treated with a BTX-A injection. All participants were recruited at the department of Oral and Maxillofacial Surgery (OMS) of the Diakonessenhuis, Utrecht, The Netherlands.

You may qualify if:

• TMD-related myalgia in accordance with the DC/TMD;
• Accepted BTX-A injections as treatment;
• Age ≥ 18 years;
• Understanding of the Dutch language to fill in the questionnaires.

You may not qualify if:

• Systemic inflammatory and connective tissue diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis);
• Surgery in the TMJ area \< 12 months ago;
• Pain of dental origin;
• Limited cognitive functioning (not allowed to make medical decisions);
• Use of muscle relaxants, or aminoglycoside antibiotics;
• A history of allergic reactions to BTX;
• Pregnancy and lactation.

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead
• Fysiotherapie Utrecht Oost B.V.: collaborator

Study Sites (1)

Diakonessenhuis Utrecht

Utrecht, Utrecht, 3582 KE, Netherlands

Location

Related Publications (6)

• Patel J, Cardoso JA, Mehta S. A systematic review of botulinum toxin in the management of patients with temporomandibular disorders and bruxism. Br Dent J. 2019 May;226(9):667-672. doi: 10.1038/s41415-019-0257-z.

  PMID: 31076698 BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

• Gil-Martinez A, Paris-Alemany A, Lopez-de-Uralde-Villanueva I, La Touche R. Management of pain in patients with temporomandibular disorder (TMD): challenges and solutions. J Pain Res. 2018 Mar 16;11:571-587. doi: 10.2147/JPR.S127950. eCollection 2018.

  PMID: 29588615 BACKGROUND

• De la Torre Canales G, Poluha RL, Lora VM, Araujo Oliveira Ferreira DM, Stuginski-Barbosa J, Bonjardim LR, Cury AADB, Conti PCR. Botulinum toxin type A applications for masticatory myofascial pain and trigeminal neuralgia: what is the evidence regarding adverse effects? Clin Oral Investig. 2019 Sep;23(9):3411-3421. doi: 10.1007/s00784-019-03026-4. Epub 2019 Jul 24.

  PMID: 31342244 BACKGROUND

• Chisnoiu AM, Picos AM, Popa S, Chisnoiu PD, Lascu L, Picos A, Chisnoiu R. Factors involved in the etiology of temporomandibular disorders - a literature review. Clujul Med. 2015;88(4):473-8. doi: 10.15386/cjmed-485. Epub 2015 Nov 15.

  PMID: 26732121 BACKGROUND

• Sipahi Calis A, Colakoglu Z, Gunbay S. The use of botulinum toxin-a in the treatment of muscular temporomandibular joint disorders. J Stomatol Oral Maxillofac Surg. 2019 Sep;120(4):322-325. doi: 10.1016/j.jormas.2019.02.015. Epub 2019 Feb 23.

  PMID: 30807862 BACKGROUND

MeSH Terms

Conditions

Myalgia; Facial Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Maurits HT de Ruiter, Dr.

  Diakonessenhuis, Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: January 26, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

NL (1)