FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048109 [Registered on: 14/12/2022] Trial Registered Prospectively
Last Modified On: 12/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [ACUPUNCTURE]  
Study Design  Other 
Public Title of Study   EFFECT OF ACUPUNCTURE TREATMENT IN LONG TERM PAIN IN MOUTH AND FACE REGION 
Scientific Title of Study   EFFICIENCY OF ACUPUNCTURE TREATMENT MODALITY IN THE MANAGEMENT OF CHRONIC OROFACIAL PAIN DISORDER 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR R SHIYAMALA 
Designation  POST GRADUATE 
Affiliation  CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City,Kelambakkam,Chennai 603103
Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City, Kelambakkam, Chennai 603103
Kancheepuram
TAMIL NADU
603103
India 
Phone  9940687651  
Fax    
Email  drshiyamala0608@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRCHRISTEFFI MABEL 
Designation  HEAD OF DEPARTMENT 
Affiliation  CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City, Kelambakkam, Chennai 603103CITY,KELAMBAKKAM,CHENNAI 603103
Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City,Kelambakkam,Chennai 603103
Kancheepuram
TAMIL NADU
603103
India 
Phone  8903777499  
Fax    
Email  christeffimabelr@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DRRSHIYAMALA 
Designation  POST GRADUATE 
Affiliation  CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City, Kelambakkam, Chennai 603103CITY,KELAMBAKKAM,CHENNAI 603103
Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City, Kelambakkam, Chennai 603103CITY,KELAMBAKKAM,CHENNAI 603103
Kancheepuram
TAMIL NADU
603103
India 
Phone  9940687651  
Fax    
Email  drshiyamala0608@gmail.com  
 
Source of Monetary or Material Support  
ROOM NO-1 ,E BLOCK,DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY,CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE,CHETTINAD HEALTH CITY.KELAMBAKKAM,CHENNAI 603013 
 
Primary Sponsor  
Name  CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City,Kelambakkam,Chennai 603103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRRSHIYAMALA  CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE  Department OF Oral Medicine And Radiology ,ROOM NO-1 E BLOCK, Chettinad Dental College And Research Institute, Chettinad Health City,Kelambakkam,Chennai 603103COLLEGE AND RESEARCH INSTITUTE,CHETTINAD HEALTH CITY,KELAMBAKKAM,CHENNAI 603103
Kancheepuram
TAMIL NADU 
9940687651

drshiyamala0608@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL HUMAN ETHICS COMMITTEE FOR STUDENT RESEARCH-CARE-IHEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G501||Atypical facial pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  acupuncture   Patients with chronic orofacial pain are diagnosed using pulse diagnoses and are recorded in digital meridian treated with acupuncture treatment for duration of 15 days with each session of 20 minutes 
Comparator Agent  Not applicable  not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  This interventional study includes subjects (Male and Female) reporting to the DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY and presenting with clinical signs and symptoms of CHRONIC OROFACIAL PAIN 
 
ExclusionCriteria 
Details  Exclusion criteria includes patients with chronic pain due to systemic illness, patients with history of bleeding disorder ,patients who are under immunosuppression drugs, patients who are pregnant.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to measure the short term pain reduction using Short form McGill pain questionnaire at baseline and 2nd,4th,6th day of session  The primary outcome is to measure the short term pain reduction using Short form McGill pain questionnaire at baseline and 2nd,4th,6th day of session 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to measure the long term pain reduction with acupuncture treatment at the end of 1st,3rd,6th month post treatment.   1st,3rd,6th month  
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT APPLICABLE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE OF THE STUDY

EFFICIENCY OF ACUPUNCTURE TREATMENT MODALITY IN THE MANAGEMENT OF CHRONIC OROFACIAL PAIN DISORDER

INTRODUCTION AND BACKGROUND

Orofacial pain has been defined as "pain localised to the region above the neck, in front of the ears, below the orbitomeatal line, within the oral cavity,(including pain of dental origin and temperomandibular disorders)

Chronic orofacial pain (OFP) comprises a heterogeneous group of disorders that cause ongoing pain in the head and face region. There are many patients who complain about intractable OFP. Developing therapeutic strategies for OFP disorders, exact knowledge of trigeminal mechanism of pain and nociception is thus indispensible. OFP is a highly prevalent and debilitating condition.

Acupuncture affects the neurovascular network and can radically change the impedances of meridians or neurovascular bundles. Therefore, both the match and mismatch of acupuncture meridian impedances with the pain source or brain impedance can reduce pain symptoms. Acupuncture provides overall coordination, helping to achieve the state of relative equilibrium of body and mind. Acupuncture therapy is complementary and alternative medicine as a potential therapeutic procedure with scientific evidence characterized as unique pathophysiological concept of disease, key components of which are flow of qi, kind of energy. The principle behind immediate suppression of pain is by DNIC (diffuse noxious inhibitory control).Acupuncture treatment is done by inserting needles and applying heat or electrical stimulation at very precise acupuncture point. Needle activates the A delta and C afferent nerve fibre in a muscle sends signals to the spinal cord, where dynorphin and enkephalins are released and continue to midbrain triggering excitatory and inhibitory mediators in the spinal cord .Ensuing release of seratonin and norepinephrine into the spinal cord leads to pain conduction being inhibited both pre and post synaptically in the spinothalamic tract. Finally, these signals arrive at the hypothalamus and pituitary glands, triggering release of adrenocorticotropic hormones and β -endorphin.

There have been more than 10 systematic reviews of acupuncture for chronic pain since 2010.In 1998,a review a paper on use of acupuncture revealed 11 out of 15 papers that has been published and proved acupuncture has effective results in treating temperomandibular joint disorder.  ,A study by conducted on short term effect of acupuncture in masticatory muscles concluded pain tolerance of masticatory muscle is more in acupuncture. The purpose of this study is i) to assess the alleviation of chronic orofacial pain with 6 months follow up modality in regional population ii) to add the outcome of the study to the available scientific data .

STUDY POPULATION-This interventional study includes subjects (Male and Female) reporting to the DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY and presenting with clinical signs and symptoms of CHRONIC OROFACIAL PAIN will be taken. Patients will be explained and educated about the acupuncture treatment modality.

ETHICAL CONSIDERATION

Ethical clearance will be obtained from CHETTINAD ACADEMY OF RESEARCH AND EDUCATION(CARE).Consent will be obtained from the participants on a standardized form of the Ethical Review Committee

METHODOLOGY

The study subject included in the study will be examined.

Clinical proforma consisting of demographic data, history of presenting illness, past medical history, past dental history, personal history , psychological assessment, extra oral examination, intra oral examination are duly filled in .

Clinical diagnosis will be established. Screening (Orthopantomogram)X ray will be taken to evaluate organic changes followed by final diagnosis. Patient will be explained about the possible treatment modalities to alleviate symptoms. Informed consent will be obtained from the patient for acupuncture therapy. Patients will be referred and accompanied by the investigator for acupuncture therapy. The certified acupuncturist will evaluate the patient and plan the treatment accordingly. Patients will be accompanied by the investigator to acupuncturist for all the scheduled treatment session. All patients will be treated by the same acupuncturist.

Short form McGill pain questionnaire (SF-MCGILL)will be recorded at the baseline and after the acupuncture treatment which consisted of inserting acupuncture needles into acupuncture points and leaving the needles in for 30 minutes. All patients will have acupuncture point Hoku (LI 4) needled bilaterally, as well as other points on the head and neck, which will vary from patient to patient, depending on the diagnosis and clinical findings.

The efficacy of acupuncture treatment modality in chronic orofacial pain management is assessed based on comparison of scoring done before the onset of the treatment and after the completion of the treatment The pain relief achieved from each session is quantified by comparing the score obtained before and after each session of therapy. Patients follow up is done at 1st,3rd,6th month to assess the pain relief achieved following acupuncture therapy, using Short form McGill pain questionnaire (SF-MCGILL)



 
Close