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Completed

NCT Number: NCT06824324

The Use of Botulinum Toxin in the Management of Myofascial Pain Syndrome

The objective of this study was to assess the efficacy of Botulinum toxin type (A) (BoNTA) injection in Myofascial pain syndrome management in the terms of duration of function improvement and pain reduction.

Material and methods: Fourteen patients with Myofascial pain syndrome related to masticatory muscles were presented with trismus, pain and impairment of oral function. Treatment plan was established by utilizing thirty units of Botulinum toxin type (A) which was injected into masseter and sometimes temporalis muscle.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

College Of Dentistry University Of Baghdad

Baghdad, Iraq

About this study

Myofascial pain syndrome (MPS) is acute or chronic musculoskeletal pain that characterized by the presence of unique trigger points of pain (TrPs) . Etiology of this condition may include psychogenic stress, prolong muscle strain, trauma to the joint or muscle, arthritis, myositis, chronic infection, and general fatigue. Current therapeutic approaches available for Myofascial pain syndrome involved pharmacological and non-pharmacological treatment options. The non-pharmacological techniques may include a) manual therapy by muscle stretch or massage, b) muscular taut band injection by local anesthesia or botulinum toxin, c) acupuncture, and d) therapeutic ultrasound .

Botulinum toxin is a neurotoxin protein produced by anaerobic bacteria (clostridium botulinum) . It was first discovered by a German physician named Justinus Kerner who observed that the toxin acts by impeding signal transmission in the somatic and autonomic motor systems, leaving the sensory signal transmission uninterrupted .

It blocked the acetylcholine release from the nerve endings thus prevent the neurological signals transmission at the neuromuscular junction. In turn, this reduces the muscle contraction and produces relaxation of the muscle . However, the clinical effects of Botulinum toxin are transit as these neurotoxins degenerate at nerve terminals and became inefficient after a period of time .

Although numerous articles were published on the Botulinum Toxin A (BoNTA) injection in the management of MPS, but there were diverse clinical results in the literature regarding this subject and its effectiveness is still questionable . The objective of this study was to evaluate the efficiency and outcomes of BoNTA injection in the management of MPS related to masticatory muscles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with myofascial pain related to the muscles of mastication (masseter and temporalis muscle).
  • Patient with regional pain.
  • Patient with or without limited mouth opening (trismus).
  • Presence of trigger points within the identified masticatory muscles.

Exclusion criteria

  • 1. Hypersensitivity to Botulinum toxin. 2. Active infection in the virtual points of injection. 3. Patient with generalized musculoskeletal pain as in Fibromyalgia Syndrome (FMS).
  • Children younger than 12 years old and pregnant woman. 5-Patient recently undergone to one other modality of treatment

Treatment and study plan

intramuscular Botulinum Toxin

Drug

A thirty units of Botulinum toxin A was injected intramuscularly in Triger zone of patient with myofascial pain syndrome

Primary outcomes

  1. Pain level

    Time frame: 16 weeks

    Pain level was assessed before the initiation of treatment and at 2, 8 and 16 weeks after injection by using the visual analogue scale

Secondary outcomes

  1. Mouth opening

    Time frame: 16 weeks

    Mouth opening was also measured prior and after BoNTA injection by digital caliper. Follow up period was 4 months after the initial injection. Descriptive statics for (pre -post) operative pain and mouth opening at 2 weeks, 16 weeks after injection

Sponsors and collaborators

Lead sponsor

Yassir R. Al-khannaq

Other

Registry information

Official study title

Is Botulinum Toxin Predictable in the Management of Myofascial Pain Syndrome Related to Masticatory Muscles?

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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