Patients with Jaw Muscles Myofascial PainPhase 2/3NCT06814535
A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain
A Phase 2/3 study testing Botulinum Toxin A / Botulinum Toxin A and Platelet rich plasma in people with Patients with Jaw Muscles Myofascial Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain . The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients with Jaw Muscles Myofascial Pain
- What is being tested?
- Botulinum Toxin A / Botulinum Toxin A and Platelet rich plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 31 Mar 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.
- 18 years or More "Willingness to follow instructions.
Who cannot join
- therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.
- Clinical conditions as pregnancy
- Medical problems that will interfere with the procedure as bleeding disorders.
- Cognitive impairment or present inadequate cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain
This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .
The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.
Read more
The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.
The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.
The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .
At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.
Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .
- Being tested
- Botulinum Toxin A / Botulinum Toxin A, Platelet rich plasma, Saline -- placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A / Botulinum Toxin ADrug
Botulinum toxin type A
Platelet rich plasmaDrug
Plasma that contains concentrated platelets
Saline -- placebo comparatorDrug
Physiological saline .9 %
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Active comparator | 20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis Receives: Drug: Botulinum Toxin A / Botulinum Toxin A |
| Platelet rich plasma | Active comparator | 20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis |
| Physiologic saline | Placebo comparator | 20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point..
Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment
Measured: 3 months
Current pain intensity
The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome
Measured: 3 months
Worst pain intensity
The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain .
Decrease in pain intensity means better outcome
Measured: 3 months
Secondary outcomes (3)
Inter incisal opening
The measurement in millimeters of the distance between the incisal edge of the upper incisor and the lower incisor Using calibers to measure the effect of myofascial pain on decreasing muscle spasm and the effectiveness of the treatment by time.
Increased degree of mouth opening meaning the muscles had relaxed and trigger points released
Measured: 3 months
Patient satisfaction
Will be measured by Likert scale by faces to indicate whether the treatment was satisfactory to the patient or not and to which degree .it affected their quality of life
Measured: 3 months
The need for analgesics
The patient will count how many Paracetamol tabs he took at the time from the last visit till now.
With decreased amount of analgesics taken between the visits means better outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jun 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Jaw Muscles Myofascial PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa abdelrahman abdelhakeem sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814535
- Sponsor's protocol ID
- CEBD_CU_9122023
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2025
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain
- ClinicalTrials.gov ID
- NCT06814535
- Acronym / sponsor ID
- CEBD_CU_9122023
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 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.
This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .
The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.
The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.
The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.
The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .
At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.
Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Active comparator | Drug: Botulinum Toxin A / Botulinum Toxin A20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis |
| Platelet rich plasma | Active comparator | –20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis |
| Physiologic saline | Placebo comparator | –20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.
Key exclusion criteria (4 listed)
- therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.
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 |
|---|---|---|
| Botulinum Toxin A / Botulinum Toxin ABotulinum toxin type A | Drug | Botulinum toxin A |
| Platelet rich plasmaPlasma that contains concentrated platelets | Drug | – |
| Saline -- placebo comparatorPhysiological saline .9 % | Drug | – |
Primary outcome
Pressure pain threshold
Time frame: 3 months
The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point.. Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment
Current pain intensity
Time frame: 3 months
The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome
Worst pain intensity
Time frame: 3 months
The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain . Decrease in pain intensity means better outcome
3 secondary outcomes
Inter incisal opening
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
The need for analgesics
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing Botulinum Toxin A / Botulinum Toxin A and Platelet rich plasma in people with Patients with Jaw Muscles Myofascial Pain, run by Cairo 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Pressure pain threshold (time frame: 3 months). The study lists 3 primary outcomes in all. 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 11 Mar 2025.