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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06824324
Enrollment
14
Registered
2025-02-13
Start date
2024-03-12
Completion date
2025-01-06
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofacial Pain Syndrome

Brief summary

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.

Detailed description

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.

Interventions

DRUGintramuscular Botulinum Toxin

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

Sponsors

Yassir R. Al-khannaq
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient with myofascial pain related to the muscles of mastication (masseter and temporalis muscle). 2. Patient with regional pain. 3. Patient with or without limited mouth opening (trismus). 4. 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). 4\. Children younger than 12 years old and pregnant woman. 5-Patient recently undergone to one other modality of treatment

Design outcomes

Primary

MeasureTime frameDescription
Pain level16 weeksPain level was assessed before the initiation of treatment and at 2, 8 and 16 weeks after injection by using the visual analogue scale

Secondary

MeasureTime frameDescription
Mouth opening16 weeksMouth 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

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026