Botulinum Toxin A in Patients With Myofascial Pain Syndrome With and Without Zinc Supplementation

NCT05605886 | Unknown Early Phase 1

• 1 other identifier: botox in myofacial pain
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: Dose the use of oral zinc supplement improve the effects of botulinum toxins injection in patients with myofascial pain dysfunction syndrome? Statement of the problem: MPDS Patients treated with botulinum toxin A injection usually suffers from return of the symptoms which requires successive injections almost every (3-4M) Rationale for conducting the research: The concept of adding the zinc supplementation prior to BTXA injection is contributed to the fact that botulinum toxin is a zinc-dependent metalloprotease; therefore, every botulinum toxin molecule must be accompanied with a zinc molecule to effectively paralyze a muscle. However, commercially available BTXA preparations exclude zinc from their preparations, and BTX clinical efficiency and duration varies according to the zinc levels of the patient. Although the BTX effect could remain for several months, its zinc-dependent proteolytic activity befalls within hours of administration before the toxins are degraded in the tissues. Therefore, for achieving better results from BTX, the recipients should have adequate zinc levels at the time of administration. Therefore, oral zinc supplement intake prior to BTXA injection may enhance its clinical efficiency and duration. botulinum neurotoxins are the most potent toxins known. They bind to nerve cells, penetrate the cytosol and block neurotransmitter release. Comparison of their predicted amino acid sequences reveals a highly conserved segment that contains the HExxH zinc binding motif of metalloendo peptidases. The metal content of tetanus toxin was then measured and it was found that one atom of zinc is bound to the light chain of tetanus toxin. Zinc could be reversibly removed by incubation with heavy metal chelators. Zn2+ is coordinated by two histidines with no involvement in cysteines, suggesting that it plays a catalytic rather than a structural role. Bound Zn + was found to be essential for the tetanus toxin inhibition of neurotransmitter release in Aplysia neurons injected with the light chain. The intracellular activity of the toxin was blocked by phosphoramidon, a very specific inhibitor of zinc endopeptidases. Purified preparations of light chain showed a highly specific proteolytic activity against synaptobrevin, an integral membrane protein of small synaptic vesicles. The present findings indicate that tetanus toxin, and possibly also the botulinum neurotoxins, are metalloproteases and that they block neurotransmitter release via this protease activity. So The use of zinc supplementation prior to BTXA injection has been suggested by several previous studies to prolong its duration of action as well as improve its efficacy

Conditions

Myofacial Pain Syndrome; Botulinum Toxin

Outcome Measures

Primary Outcomes (2)

• Muscular Activity

  will be assessed by EMG

  4 months

• Pressure Pain Threshold (PPT)

  will be assessed by algometer

  4 months

Study Arms (2)

first group: (Control group)

PLACEBO COMPARATOR

1. EMG will be performed for masseter \& temporalis muscles at the diagnosis appointment. 2. Patients will recieve a daily placebo tablet in the morning after breakfast for 4 days prior to injections. 3. Patients will receive a one-time treatment of 50 units of BoNT-A, the dose will be injected into the bilateral masseter muscles (16.7 units each masseter) and 1/3 into the bilateral temporalis (8.3 units each temporalis). 4. Follow up will be performed using EMG for the masseter and temporalis muscles 4 months after the BoNT-A injection.

Drug: placebo

second group. (intervention group)

ACTIVE COMPARATOR

1. EMG will be performed for masseter \& temporalis muscles at the diagnosis appointment. 2. Patients will receive a daily zinc supplement tablets of 50 mg in the morning after breakfast for 4 days prior to injections. 3. Patients will receive a one-time treatment of 50 units of BoNT-A, the dose will be injected into the bilateral masseter muscles (16.7 units each masseter) and 1/3 into the bilateral temporalis (8.3 units each temporalis). 4. Follow up will be performed using EMG for the masseter and temporalis muscles 4 months after the BoNT-A injection.

Drug: Solvazinc 50mg

Interventions

Solvazinc 50mg DRUG

Patients will receive a daily zinc supplement tablets of 50 mg in the morning after breakfast for 4 days prior to injections.

Also known as: zinc supplement

second group. (intervention group)

placebo DRUG

placebo

first group: (Control group)

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with myofascial pain
• Both genders males and females will be included.
• Ages from 17:50 Y
• General good health
• With complete dentation

You may not qualify if:

• Subjected to irradiation in the head and neck area less than 1 year ago
• Edentulous patients
• Patient with recent trauma.
• Poor motivation.
• Active infection area related to masseter or temporalis.
• Patient with anti-tetanus vaccine 1-3 m before experiment

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Manial, 67845, Egypt

Location

Related Publications (4)

• Cohen JL. Scientific skepticism and new discoveries: an analysis of a report of zinc/phytase supplementation and the efficacy of botulinum toxins in treating cosmetic facial rhytides, hemifacial spasm and benign essential blepharospasm. J Cosmet Laser Ther. 2014 Oct;16(5):258-62. doi: 10.3109/14764172.2014.948882. Epub 2014 Sep 2.

  PMID: 25105993 BACKGROUND

• Lebeda FJ, Cer RZ, Mudunuri U, Stephens R, Singh BR, Adler M. The zinc-dependent protease activity of the botulinum neurotoxins. Toxins (Basel). 2010 May;2(5):978-97. doi: 10.3390/toxins2050978. Epub 2010 May 7.

  PMID: 22069621 BACKGROUND

• Schiavo G, Poulain B, Rossetto O, Benfenati F, Tauc L, Montecucco C. Tetanus toxin is a zinc protein and its inhibition of neurotransmitter release and protease activity depend on zinc. EMBO J. 1992 Oct;11(10):3577-83. doi: 10.1002/j.1460-2075.1992.tb05441.x.

  PMID: 1396558 BACKGROUND

• DE LA Torre Canales G, Camara-Souza MB, Poluha RL, Grillo CM, Conti PCR, Sousa MDLR, Rodrigues Garcia RCM, Rizzatti-Barbosa CM. Botulinum toxin type A and acupuncture for masticatory myofascial pain: a randomized clinical trial. J Appl Oral Sci. 2021 Jun 4;29:e20201035. doi: 10.1590/1678-7757-2020-1035. eCollection 2021.

  PMID: 34105695 BACKGROUND

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Nadia Galal

  professor

  STUDY DIRECTOR

• Omnia Adel aziz

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 2 Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelop the day of procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients involved in this study will be divided in to two different groups, one group will undergo zinc supplement then botulinum toxins injection in masseter and temporalis muscle while the other group will have botulinum toxins injection in masseter and temporalis muscle without previous zinc supplement

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: November 4, 2022
• Study Start: May 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: May 20, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)