Myofacial Pain SyndromePhase 1/2NCT06824324
The Use of Botulinum Toxin in the Management of Myofascial Pain Syndrome
A Phase 1/2 study testing intramuscular Botulinum Toxin in people with Myofacial Pain Syndrome, run by Yassir R. Al-khannaq at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Myofacial Pain Syndrome
- What is being tested?
- intramuscular Botulinum Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIraq
- Study dates
- 12 Mar 2024to 6 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Botulinum Toxin Predictable in the Management of Myofascial Pain Syndrome Related to Masticatory Muscles?
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.
Read the 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
- Being tested
- intramuscular Botulinum Toxin
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular Botulinum ToxinDrug
A thirty units of Botulinum toxin A was injected intramuscularly in Triger zone of patient with myofascial pain syndrome
| Study group | Role | What they receive |
|---|---|---|
| injection of Botulinum toxin A in Triger zone | Active comparator | 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 Receives: Drug: intramuscular Botulinum Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start12 Mar 2024
- Primary completion4 Nov 2024
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yassir R. Al-khannaq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yassir R. Al-khannaq, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824324
- Sponsor's protocol ID
- 1004125
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Botulinum Toxin Predictable in the Management of Myofascial Pain Syndrome Related to Masticatory Muscles?
- ClinicalTrials.gov ID
- NCT06824324
- Acronym / sponsor ID
- 1004125
- Conditions
- Myofacial Pain Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yassir R. Al-khannaqUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| injection of Botulinum toxin A in Triger zone | Active comparator | Drug: intramuscular Botulinum ToxinThe 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intramuscular Botulinum ToxinA thirty units of Botulinum toxin A was injected intramuscularly in Triger zone of patient with myofascial pain syndrome | Drug | injection of Botulinum toxin A in Triger zone |
Primary outcome
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
1 secondary outcome
Mouth opening
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Myofacial Pain Syndrome
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
Myofacial Pain Syndrome, Chronic Neck Pain
Recruiting
Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Myofacial Pain Syndrome
Recruiting
Massage Gun vs Deep Friction Massage for Upper Trapezius Trigger Points
Myofacial Trigger Points of Upper Trapezius
Not yet recruiting
Artificial Intelligence Clinical Decision
Myofacial Pain Syndrome, Clinical Decision Support
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intramuscular Botulinum Toxin in people with Myofacial Pain Syndrome, run by Yassir R. Al-khannaq at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.