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

NCT ID: NCT06824324

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-01-06

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.

Conditions

Myofacial Pain Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

injection of Botulinum toxin A in Triger zone

The method utilized for dilution of Botulinum toxin A involved addition of 2.5ml of normal saline to 100 unit of Botox vial, and addition of 1.25ml to 50U of Botox so each 0.1ml contain 4U of Botox.

Botox can be denatured easily so the dilution process was very precise and the dilute injected gently in to Botox Vial.

A thirty units of Botulinum toxin A was injected intramuscularly bilaterally (30 U for each side) in thirteen patients and unilaterally in one patient

Group Type: ACTIVE_COMPARATOR

intramuscular Botulinum Toxin

Intervention Type: DRUG

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

Interventions

intramuscular Botulinum Toxin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yassir R. Al-khannaq

OTHER

Sponsor Role: lead

Responsible Party

Yassir R. Al-khannaq

LECTURER Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

College Of Dentistry University Of Baghdad

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

1004125

Identifier Type: -

Identifier Source: org_study_id