Myofascial Trigger Point PainEarly Phase 1NCT06013644
Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome
A Early Phase 1 study testing Acupuncture needle, Dry needle and Botox Injectable Product in people with Myofascial Trigger Point Pain and Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain, Myofascial Pain Syndrome
- What is being tested?
- Acupuncture needle, Dry needle and Botox Injectable Product
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2023to 1 Feb 2024
- Phase
- Early Phase 1
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Volunteers
- MPDS patient
- Adult patients of both sexes, aged from 15 to 60 years
- signs and symptoms of pain or muscles spams
- Trigger points in masticatory muscles
- Patients had not received any other form of surgical treatment related to TMJ disorders
- Cooperative patient
Who cannot join
- Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia
- Edentulous patients, and total dental prosthesis.
- Psychologically disturbed and mental disturbance patients
- major systemic disorders (- Valvular heart disease: avoid indwelling needles)
- seizure patients
- A confirmed or suspected diagnosis of an inflammatory disorder and autoimmune.
Show all 11Show fewer
- Patient on Medication (insulin- corticosteroids, nonsteroidal anti-inflammatory therapy or narcotics, muscle relaxants, herbal medicines.)
- Analgesic or anti-depressants over the last 2 weeks.
- Any anatomical abnormality in TMJ.
- Pregnant women.
- Allergies to metals.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Wajma Sayed Karim Al Sayed
Cairo
Wajma Alsayed, 01004762274, wajmah.sayed@dentistry.cu.edu.eg
+201001545449, Hassan_ao@yahoo.com
About this study
Official title: Comparative Efficacy of Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: A Randomized Clinical Trial
Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention
Read the detailed description
All the patients will be selected and examine from the outpatient clinic of Oral and Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.
Electromyography examination will be conducted in the department of neurophysiology department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to TMJ disorders All patients involved in this study will be divided into three groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry needle, and Botox injection.
for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 weeks
- Being tested
- Acupuncture needle, Dry needle, Botox Injectable Product
- Keywords
- botox injection, dry needle, myofascial trigger point pain, acupuncture
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needleDevice
a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2
Dry needleDevice
a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes
Botox Injectable ProductDrug
each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture needle (study group A) | Active comparator | a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2 Receives: Device: Acupuncture needle |
| Dry needle (study group B) | Active comparator | a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes Receives: Device: Dry needle |
| Botox injection (study group C) | Active comparator | each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms Receives: Drug: Botox Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of electrical activity of mastication muscles from the baseline measurement
change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
Measured: 2 months after treatment
change of electrical activity of mastication muscles from the baseline measurement
change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
Measured: 6 months after treatment
Secondary outcomes (2)
change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
Measured: 2 months after treatment
change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start3 Jun 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wajmah Sayed Karim Al Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013644
- Sponsor's protocol ID
- 17223
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the study data will be available upon publication after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06013644
- Acronym / sponsor ID
- 17223
- Keywords
- botox injection, dry needle, myofascial trigger point pain, acupuncture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 28 Aug 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.
Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention
Detailed description
All the patients will be selected and examine from the outpatient clinic of Oral and Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt.
Electromyography examination will be conducted in the department of neurophysiology department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to TMJ disorders All patients involved in this study will be divided into three groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry needle, and Botox injection.
for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture needle (study group A) | Active comparator | Device: Acupuncture needlea weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2 |
| Dry needle (study group B) | Active comparator | Device: Dry needlea weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes |
| Botox injection (study group C) | Active comparator | Drug: Botox Injectable Producteach patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy Volunteers
- MPDS patient
- Adult patients of both sexes, aged from 15 to 60 years
- signs and symptoms of pain or muscles spams
- Trigger points in masticatory muscles
Key exclusion criteria (11 listed)
- Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia
- Edentulous patients, and total dental prosthesis.
- Psychologically disturbed and mental disturbance patients
- major systemic disorders (- Valvular heart disease: avoid indwelling needles)
- seizure patients
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 |
|---|---|---|
| Acupuncture needlea weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2 | Device | Acupuncture needle (study group A) |
| Dry needlea weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes | Device | Dry needle (study group B) |
| Botox Injectable Producteach patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms | Drug | Botox injection (study group C) |
Primary outcome
change of electrical activity of mastication muscles from the baseline measurement
Time frame: 2 months after treatment
change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
change of electrical activity of mastication muscles from the baseline measurement
Time frame: 6 months after treatment
change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching)
2 secondary outcomes
change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
Time frame: 2 months after treatment
change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible)
Time frame: 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: Undecided. All the study data will be available upon publication after completion of the study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acupuncture needle, Dry needle and Botox Injectable Product in people with Myofascial Trigger Point Pain and Myofascial Pain Syndrome, 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 7 inclusion and 11 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 28 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of electrical activity of mastication muscles from the baseline measurement (time frame: 2 months after treatment). 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 28 Aug 2023.