Myofacial PainPhase 2NCT05673655
Intraoral Injection of Trigger Points by Botox
A Phase 2 study testing intraoral trigger point injection by botox and transcutaneous trigger point injection by botox in people with Myofacial Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofacial Pain
- What is being tested?
- intraoral trigger point injection by botox and transcutaneous trigger point injection by botox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2022to 25 Feb 2023
- Phase
- Phase 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite diagnosis of myofascial pain with a referral
- the presence of one or more trigger points in the unilateral or bilateral masseter muscle -
- no history of any invasive procedures in the related masseter muscle
Who cannot join
- Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).
- Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
- pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle
Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).
- Conditions
- Myofacial Pain
- Being tested
- intraoral trigger point injection by botox, transcutaneous trigger point injection by botox
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoral trigger point injection by botoxDrug
intraoral injection of trigger point of masseter muscle by botulinum toxin
transcutaneous trigger point injection by botoxDrug
transcutaneous injection of masseter muscle by botulinum toxin
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous injection | Active comparator | Not described Receives: Drug: transcutaneous trigger point injection by botox |
| intraoral injection | Active comparator | Not described Receives: Drug: intraoral trigger point injection by botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
Measured: 6 weeks post injection
Secondary outcomes (1)
(OHIP-14) scale
OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start25 Dec 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion25 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673655
- Sponsor's protocol ID
- EC2213
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shabaan AA, Kassem I, Aboulmagd I, Amer IA, Shaaban A, Abd-El-Ghafour M, Refahee SM. Effectiveness of intra-oral botulinum toxin injection in comparison to the extra-oral approach on pain and quality of life in patients with myofascial pain: a randomized clinical trial. Clin Oral Investig. 2024 Dec 17;29(1):18. doi: 10.1007/s00784-024-06051-0.
PubMed 39681752
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle
- ClinicalTrials.gov ID
- NCT05673655
- Acronym / sponsor ID
- EC2213
- Conditions
- Myofacial Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 25 Feb 2023 (estimated)
- First posted
- 6 Jan 2023 (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.
Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous injection | Active comparator | Drug: transcutaneous trigger point injection by botox |
| intraoral injection | Active comparator | Drug: intraoral trigger point injection by botox |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Definite diagnosis of myofascial pain with a referral
- the presence of one or more trigger points in the unilateral or bilateral masseter muscle -
- no history of any invasive procedures in the related masseter muscle
Key exclusion criteria (3 listed)
- Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).
- Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
- pregnancy and lactation.
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 |
|---|---|---|
| intraoral trigger point injection by botoxintraoral injection of trigger point of masseter muscle by botulinum toxin | Drug | intraoral injection |
| transcutaneous trigger point injection by botoxtranscutaneous injection of masseter muscle by botulinum toxin | Drug | transcutaneous injection |
Primary outcome
pain score
Time frame: 6 weeks post injection
The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
1 secondary outcome
(OHIP-14) scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 39681752Shabaan AA, Kassem I, Aboulmagd I, Amer IA, Shaaban A, Abd-El-Ghafour M, Refahee SM. Effectiveness of intra-oral botulinum toxin injection in comparison to the extra-oral approach on pain and quality of life in patients with myofascial pain: a randomized clinical trial. Clin Oral Investig. 2024 Dec 17;29(1):18. doi: 10.1007/s00784-024-06051-0.
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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 2 study testing intraoral trigger point injection by botox and transcutaneous trigger point injection by botox in people with Myofacial Pain, run by Fayoum University at 1 site in Egypt.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. 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 Egypt. 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 phase mean?
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?
Results are not available in the source record.
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 score (time frame: 6 weeks post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673655, which also lists 1 linked publication.
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 10 Jan 2023.