Clinical trial NCT06013644: Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Myofascial Trigger Point Pain
Myofascial Pain Syndrome
Keywords: botox injection
dry needle
myofascial trigger point pain
acupuncture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 39
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: Accepts Healthy Volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: change of electrical activity of mastication muscles from the baseline measurement
timeFrame: 2 months after treatment
measure: change of electrical activity of mastication muscles from the baseline measurement
timeFrame: 6 months after treatment
Secondary outcomes:
measure: 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)
timeFrame: 2 months after treatment
measure: 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)
timeFrame: 6 months after treatment
Other outcomes:
measure: Patient Satisfaction questionnaire
timeFrame: 2 months after treatment
measure: Patient Satisfaction questionnaire
timeFrame: 6 months after treatment
Locations:
city: Cairo
country: Egypt
facility: Wajma Sayed Karim Al Sayed
Study officials:
References: