Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle

NCT06676475 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 200036178
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:

• which treatment has longer effect of pain release with the least possible side effects and recurrence rate?
• Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times
• 1st visit will include taking preoperative records and treatment injection
• 2nd visit will be follow up and taking records after 1 month
• 3rd visit will be follow up and taking records after 3 months
• 4th visit will be follow up and taking records after 6 months

Conditions

Myofacial Pain; Trigger Points, Myofascial

Keywords

myofascial pain; masseter trigger point; MPS; MTrPs; MgSO4 in myofascial trigger points; BTA in myofascial trigger points; Botox in masseter trigger points; magnesium sulfate in masseter trigger points

Outcome Measures

Primary Outcomes (1)

• Evaluating pain

  Pain will be recorded with a visual analog scale (VAS of 0-10, with zero being no pain and 10 the worst pain possible)

  preoperative - post operative - 1 , 3 ,6 months follow up

Secondary Outcomes (3)

• Pain-free maximum mouth opening (MMO)

  preoperative - post operative - 1 , 3 ,6 months follow up

• Muscle health and activity measured using electromyography

  preoperative - post operative - 1 , 3 ,6 months follow up

• The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14)

  preoperative - post operative - 1 , 3 ,6 months follow up

Study Arms (3)

Group I: Patients will receive Magnesium Sulfate injection into trigger points

EXPERIMENTAL

Drug: MgSO4

Group II: Patients will receive Botulinum Toxin into trigger points

ACTIVE COMPARATOR

Drug: BOTOX-A

Group III: Patients will receive Saline injection into trigger points

PLACEBO COMPARATOR

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

MgSO4 DRUG

2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).

Group I: Patients will receive Magnesium Sulfate injection into trigger points

BOTOX-A DRUG

2ml of BTX

Group II: Patients will receive Botulinum Toxin into trigger points

Saline (NaCl 0,9 %) (placebo) DRUG

2 ml of saline

Group III: Patients will receive Saline injection into trigger points

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria
• Definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
• Presence of one or more unilateral or bilateral trigger points in the masseter muscle
• No history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)

You may not qualify if:

• Any painful conditions (other than myofascial trigger points) affecting the orofacial region
• Any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy
• Pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr university for science and technology

Giza, Egypt

Location

Related Publications (16)

• Zielinski G, Bys A, Szkutnik J, Majcher P, Ginszt M. Electromyographic Patterns of Masticatory Muscles in Relation to Active Myofascial Trigger Points of the Upper Trapezius and Temporomandibular Disorders. Diagnostics (Basel). 2021 Mar 24;11(4):580. doi: 10.3390/diagnostics11040580.

  PMID: 33805008 BACKGROUND

• Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.

  PMID: 33045182 BACKGROUND

• Taskesen F, Cezairli B. The effectiveness of the masseteric nerve block compared with trigger point injections and dry needling in myofascial pain. Cranio. 2023 Mar;41(2):96-101. doi: 10.1080/08869634.2020.1820686. Epub 2020 Sep 16.

  PMID: 32935643 BACKGROUND

• Tantanatip, A. and Chang, K.V., 2018. Myofascial pain syndrome.

  BACKGROUND

• Sluka KA, Kalra A, Moore SA. Unilateral intramuscular injections of acidic saline produce a bilateral, long-lasting hyperalgesia. Muscle Nerve. 2001 Jan;24(1):37-46. doi: 10.1002/1097-4598(200101)24:13.0.co;2-8.

  PMID: 11150964 BACKGROUND

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

  PMID: 8193981 BACKGROUND

• Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol. 2004 Feb;14(1):95-107. doi: 10.1016/j.jelekin.2003.09.018.

  PMID: 14759755 BACKGROUND

• Saxena A, Chansoria M, Tomar G, Kumar A. Myofascial pain syndrome: an overview. J Pain Palliat Care Pharmacother. 2015 Mar;29(1):16-21. doi: 10.3109/15360288.2014.997853. Epub 2015 Jan 5.

  PMID: 25558924 BACKGROUND

• Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.

  PMID: 36123724 BACKGROUND

• Pihut M, Ferendiuk E, Szewczyk M, Kasprzyk K, Wieckiewicz M. The efficiency of botulinum toxin type A for the treatment of masseter muscle pain in patients with temporomandibular joint dysfunction and tension-type headache. J Headache Pain. 2016;17:29. doi: 10.1186/s10194-016-0621-1. Epub 2016 Mar 24.

  PMID: 27011213 BACKGROUND

• Nitecka-Buchta A, Walczynska-Dragon K, Batko-Kapustecka J, Wieckiewicz M. Comparison between Collagen and Lidocaine Intramuscular Injections in Terms of Their Efficiency in Decreasing Myofascial Pain within Masseter Muscles: A Randomized, Single-Blind Controlled Trial. Pain Res Manag. 2018 Jun 3;2018:8261090. doi: 10.1155/2018/8261090. eCollection 2018.

  PMID: 29973970 BACKGROUND

• Ibrahim NA, Abdel Raoof NA, Mosaad DM, Abu El Kasem ST. Effect of magnesium sulfate iontophoresis on myofascial trigger points in the upper fibres of the trapezius. J Taibah Univ Med Sci. 2021 Jan 19;16(3):369-378. doi: 10.1016/j.jtumed.2020.12.015. eCollection 2021 Jun.

  PMID: 34140864 BACKGROUND

• Fiorillo L. Spine and TMJ: A Pathophysiology Report. J Funct Morphol Kinesiol. 2020 Mar 30;5(2):24. doi: 10.3390/jfmk5020024.

  PMID: 33467240 BACKGROUND

• Dahle LO, Berg G, Hammar M, Hurtig M, Larsson L. The effect of oral magnesium substitution on pregnancy-induced leg cramps. Am J Obstet Gynecol. 1995 Jul;173(1):175-80. doi: 10.1016/0002-9378(95)90186-8.

  PMID: 7631676 BACKGROUND

• Blanco-Rueda JA, Lopez-Valverde A, Marquez-Vera A, Mendez-Sanchez R, Lopez-Garcia E, Lopez-Valverde N. Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: Uncontrolled Pilot Study. Life (Basel). 2023 Jan 28;13(2):345. doi: 10.3390/life13020345.

  PMID: 36836702 BACKGROUND

• Aikawa Y, Lynch KL, Boswell KL, Martin TF. A second SNARE role for exocytic SNAP25 in endosome fusion. Mol Biol Cell. 2006 May;17(5):2113-24. doi: 10.1091/mbc.e06-01-0074. Epub 2006 Feb 15.

  PMID: 16481393 BACKGROUND

MeSH Terms

Conditions

Facial Pain

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mayada Tarek El Menoufy

CONTACT

+2001009006845; Mayadatarek@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S. Faculty of Oral and Dental Surgery

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

EG (1)