EFFECT OF ACUPUNCTURE TREATMENT IN LONG TERM PAIN IN MOUTH AND FACE REGION

Phase 3

Not yet recruiting

• Conditions: Atypical facial pain,

• Registration Number: CTRI/2022/12/048109
• Lead Sponsor: CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE

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)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-12
• Study Start: 2022-12-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE; 🇮🇳 Kancheepuram, TAMIL NADU, India

CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE

🇮🇳Kancheepuram, TAMIL NADU, India

DRRSHIYAMALA

Principal investigator

9940687651

drshiyamala0608@gmail.com