A Phase 1/2 interventional study of intramuscular Botulinum Toxin in Myofacial Pain Syndrome, sponsored by Yassir R. Al-khannaq. Completed at 1 site in Iraq. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Yassir R. Al-khannaq · Phase 1/2, Interventional, and Treatment
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.
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Yassir R. Al-khannaq is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
Drug: intramuscular Botulinum Toxin
A thirty units of Botulinum toxin A was injected intramuscularly in Triger zone of patient with myofascial pain syndrome
Pain level
Pain level was assessed before the initiation of treatment and at 2, 8 and 16 weeks after injection by using the visual analogue scale
Time frame: 16 weeks
Mouth opening
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
Time frame: 16 weeks
Plan to share: Undecided
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Yassir R. Al-khannaq