Myofascial Pain - Dysfunction Syndrome of TMJPhase 4NCT07668375
Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain
A Phase 4 study testing Botulinum Toxin-A (Botulax - letibotulinumtoxinA) and Normal Saline in people with Myofascial Pain - Dysfunction Syndrome of TMJ, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
Purpose: The aim of this study is to investigate the effectiveness and patient reported outcomes (interincisal distance and temporomandibular myofascial pain) of treatment with intramuscularly administered BTX-A vs N/S in patients with temporomandibular myofascial pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Pain - Dysfunction Syndrome of TMJ
- What is being tested?
- Botulinum Toxin-A (Botulax - letibotulinumtoxinA) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2026to 1 Apr 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with temporomandibular myofascial pain (VAS ≥ 6) for more than one month will be included.
- Both genders.
- Age 18-70 years
Who cannot join
- Patient with history of allergic reactions with botulinum toxin-A.
- Medically compromised patients. Current pregnancy.
- Use of medication by the patients that could interfere with the effect of botulinum toxin-A (gentamycin, baclofen, atropine, revastigmine, verapamil, succinylcholine)
- Neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The aim of this study is to investigate the effectiveness and patient reported outcomes (interincisal distance and temporomandibular myofascial pain) of treatment with intramuscularly administered BTX-A vs N/S in patients with temporomandibular myofascial pain. OBJECTIVES: To determine the outcome of treatment with botulinum toxin-A vs N/S in patients with temporomandibular myofascial pain.
Read the detailed description
OPERATIONAL DEFINITIONS:
Temporomandibular myofascial pain: Presence of any one or more of the following plus positives:
Pain in the Jaw Muscles: Persistent or recurrent pain located in the muscles of mastication (muscles that move the jaw).
Tenderness on Palpation: The pain is associated with tenderness that is identified during palpation of the affected muscles, particularly in the masseter, temporalis.
Limited Range of Motion: Patients often exhibit a reduced range of motion in the jaw.
OUTCOMES:
Temporomandibular myofascial pain score: Pain score will be assessed before and after 4, 8, and 12 weeks using visual analogue scale. It would determine subjective pain experience of patients. Visual Analogue Scale (VAS) represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicates their level of pain (in cm), by marking a single point on the line.
Interincisal Distance: The interincisal distance refers to the measurement between the edges of the upper and lower central incisors when the jaw is fully opened using vernier caliper and it would be quantified in mm. Normal mouth opening ranges from 40-60 mm, mouth opening less than 40 mm would be consider as trismus.
HYPOTHESIS:
Botulinum toxin-A injection of 10-100 units would reduce the pain and increase the interincisal distance in patients with TMJ-MFP.
- Being tested
- Botulinum Toxin-A (Botulax - letibotulinumtoxinA), Normal Saline
- Keywords
- Temporomandibular Myofascial Pain, TMJ Pain, Interincisor Mouth Opening, Intramuscular Botulinum Toxin Injections
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin-A (Botulax - letibotulinumtoxinA)Drug
In this study, intramuscular injection of Botulinum Toxin-A (50-100 units) would be administered to the patient using a 1 mL insulin syringe with a 26G needle at a dilution of 10 U/mL in normal saline. Injections would be given at 5 sites: 3 in the masseter muscle and 2 in the temporalis muscle, based on the patient's side of complaint (unilateral or bilateral). Topical lidocaine 5% cream would be applied before injection. The injection aims to reduce jaw muscle pain and increase interincisal mouth opening, allowing patients to resume normal daily activities without delay.
Normal SalineDrug
Intramuscular injection of normal saline (N/S) 1 mL would be administered at the same sites (masseter and temporalis muscles) as a placebo comparator. Normal saline injection would not be expected to significantly reduce pain intensity or increase interincisal mouth opening compared to BTX-A.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin-A (BTX-A) Group | Experimental | Intramuscular injection of Botulinum Toxin-A (BTX-A) would be used in this study to evaluate its outcome on pain reduction and improvement in interincisal mouth opening in patients with temporomandibular myofascial pain. Receives: Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA); Drug: Normal Saline |
| Normal Saline (Placebo Injection) | Placebo comparator | Out of 118 patients, 59 patients would be given intramuscular injection of normal saline as a placebo. Receives: Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA); Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of post-injection pain in patients diagnosed with Temporomandibular Myofascial Pain
Pain: Post-injection pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
Measured: From enrolment to 4, 8, and 12 weeks post-injection
Measurement of Interincisal mouth opening in patients diagnosed with Temporomandibular Myofascial Pain.
Interincisal Distance: Reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a Vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
Measured: From enrolment to 4, 8, and 12 weeks post-injection
Secondary outcomes (3)
Demographic data (name, age, gender)
Name, age, gender would be used to assess the effects of demographic data on post-injection outcomes in patients with temporomandibular myofascial pain.
Measured: From enrolment to 12 weeks post-injection
Tenderness on palpation of masseter and temporalis muscles
Pain elicited upon digital palpation of the masseter and temporalis muscles would be assessed before and after injection to evaluate the effect of BTX-A on local muscle tenderness.
Measured: From enrolment to 4, 8, and 12 weeks post-injection
Adverse reactions following intramuscular injection
Any immediate or delayed adverse reactions following intramuscular injection of BTX-A or normal saline would be recorded and assessed to ensure patient safety.
Measured: From enrolment to 12 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start2 Jan 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain - Dysfunction Syndrome of TMJStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Study design: Randomized controlled trial (RCT). Study setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration of study: 06 months (after the approval of synopsis by CPSP)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azhar Ahmed, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668375
- Sponsor's protocol ID
- PGHI-IRB(DME)-RCD-06-058
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Treatment With Botulinum toxinA in Patients With Temporomandibular Myofascial Pain
- ClinicalTrials.gov ID
- NCT07668375
- Acronym / sponsor ID
- PGHI-IRB(DME)-RCD-06-058
- Keywords
- Temporomandibular Myofascial Pain, TMJ Pain, Interincisor Mouth Opening, Intramuscular Botulinum Toxin Injections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 25 Jun 2026 (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.
Purpose: The aim of this study is to investigate the effectiveness and patient reported outcomes (interincisal distance and temporomandibular myofascial pain) of treatment with intramuscularly administered BTX-A vs N/S in patients with temporomandibular myofascial pain. OBJECTIVES: To determine the outcome of treatment with botulinum toxin-A vs N/S in patients with temporomandibular myofascial pain.
Detailed description
OPERATIONAL DEFINITIONS:
Temporomandibular myofascial pain: Presence of any one or more of the following plus positives:
Pain in the Jaw Muscles: Persistent or recurrent pain located in the muscles of mastication (muscles that move the jaw).
Tenderness on Palpation: The pain is associated with tenderness that is identified during palpation of the affected muscles, particularly in the masseter, temporalis.
Limited Range of Motion: Patients often exhibit a reduced range of motion in the jaw.
OUTCOMES:
Temporomandibular myofascial pain score: Pain score will be assessed before and after 4, 8, and 12 weeks using visual analogue scale. It would determine subjective pain experience of patients. Visual Analogue Scale (VAS) represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicates their level of pain (in cm), by marking a single point on the line.
Interincisal Distance: The interincisal distance refers to the measurement between the edges of the upper and lower central incisors when the jaw is fully opened using vernier caliper and it would be quantified in mm. Normal mouth opening ranges from 40-60 mm, mouth opening less than 40 mm would be consider as trismus.
HYPOTHESIS:
Botulinum toxin-A injection of 10-100 units would reduce the pain and increase the interincisal distance in patients with TMJ-MFP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment Study design: Randomized controlled trial (RCT). Study setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration of study: 06 months (after the approval of synopsis by CPSP)
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin-A (BTX-A) Group | Experimental | Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA), Drug: Normal SalineIntramuscular injection of Botulinum Toxin-A (BTX-A) would be used in this study to evaluate its outcome on pain reduction and improvement in interincisal mouth opening in patients with temporomandibular myofascial pain. |
| Normal Saline (Placebo Injection) | Placebo comparator | Drug: Botulinum Toxin-A (Botulax - letibotulinumtoxinA), Drug: Normal SalineOut of 118 patients, 59 patients would be given intramuscular injection of normal saline as a placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with temporomandibular myofascial pain (VAS ≥ 6) for more than one month will be included.
- Both genders.
- Age 18-70 years
Key exclusion criteria (4 listed)
- Patient with history of allergic reactions with botulinum toxin-A.
- Medically compromised patients. Current pregnancy.
- Use of medication by the patients that could interfere with the effect of botulinum toxin-A (gentamycin, baclofen, atropine, revastigmine, verapamil, succinylcholine)
- Neuromuscular disorders.
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 (Botulax - letibotulinumtoxinA)In this study, intramuscular injection of Botulinum Toxin-A (50-100 units) would be administered to the patient using a 1 mL insulin syringe with a 26G needle at a dilution of 10 U/mL in normal saline. Injections would be given at 5 sites: 3 in the masseter muscle and 2 in the temporalis muscle, based on the patient's side of complaint (unilateral or bilateral). Topical lidocaine 5% cream would be applied before injection. The injection aims to reduce jaw muscle pain and increase interincisal mouth opening, allowing patients to resume normal daily activities without delay. | Drug | Botulinum Toxin-A (BTX-A) Group, Normal Saline (Placebo Injection) |
| Normal SalineIntramuscular injection of normal saline (N/S) 1 mL would be administered at the same sites (masseter and temporalis muscles) as a placebo comparator. Normal saline injection would not be expected to significantly reduce pain intensity or increase interincisal mouth opening compared to BTX-A. | Drug | Botulinum Toxin-A (BTX-A) Group, Normal Saline (Placebo Injection) |
Primary outcome
Measurement of post-injection pain in patients diagnosed with Temporomandibular Myofascial Pain
Time frame: From enrolment to 4, 8, and 12 weeks post-injection
Pain: Post-injection pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
Measurement of Interincisal mouth opening in patients diagnosed with Temporomandibular Myofascial Pain.
Time frame: From enrolment to 4, 8, and 12 weeks post-injection
Interincisal Distance: Reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a Vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
3 secondary outcomes
Demographic data (name, age, gender)
Time frame: From enrolment to 12 weeks post-injection
Tenderness on palpation of masseter and temporalis muscles
Time frame: From enrolment to 4, 8, and 12 weeks post-injection
Adverse reactions following intramuscular injection
Time frame: From enrolment to 12 weeks post-injection
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 25 Jun 2026.
- Individual participant dataSharing planned: No. As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality.
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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 4 study testing Botulinum Toxin-A (Botulax - letibotulinumtoxinA) and Normal Saline in people with Myofascial Pain - Dysfunction Syndrome of TMJ, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 25 Jun 2026. 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 Pakistan. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Measurement of post-injection pain in patients diagnosed with Temporomandibular Myofascial Pain (time frame: From enrolment to 4, 8, and 12 weeks post-injection). The study lists 2 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 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.