Back to resultsAcupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome
Primary Purpose
Myofascial Trigger Point Pain, Myofascial Pain Syndrome
Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Acupuncture needle
Dry needle
Botox Injectable Product
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring botox injection, dry needle, myofascial trigger point pain, acupuncture
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.
Sites / Locations
- Wajma Sayed Karim Al SayedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Acupuncture needle (study group A)
Dry needle (study group B)
Botox injection (study group C)
Arm Description
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
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
each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06013644
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain, Myofascial Pain Syndrome
Keywords
botox injection, dry needle, myofascial trigger point pain, acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture needle (study group A)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Dry needle (study group B)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Botox injection (study group C)
Arm Type
Active Comparator
Arm Description
each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
Intervention Type
Device
Intervention Name(s)
Acupuncture needle
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Dry needle
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Botox Injectable Product
Intervention Description
each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
Primary Outcome Measure Information:
Title
change of electrical activity of mastication muscles from the baseline measurement
Description
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)
Time Frame
2 months after treatment
Title
change of electrical activity of mastication muscles from the baseline measurement
Description
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)
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
2 months after treatment
Title
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)
Description
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)
Time Frame
6 months after treatment
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction questionnaire
Description
Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction
Time Frame
2 months after treatment
Title
Patient Satisfaction questionnaire
Description
Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Wajma Sayed Karim Al Sayed
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajma Alsayed
Phone
01004762274
Email
wajmah.sayed@dentistry.cu.edu.eg
Phone
+201001545449
Email
Hassan_ao@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
All the study data will be available upon publication after completion of the study
Learn more about this trial
Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome
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