| CTRI Number |
CTRI/2024/03/063616 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of Effectiveness of 2 local Anaesthetics in treatment of Temporomandibular Disorder. |
|
Scientific Title of Study
|
Comparative evaluation of Effectiveness of Bupivacaine Injection & Lidocaine Injection in Management of Patients with Myofascial Pain Syndrome – A randomized Controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRISHTY SNEH |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College Nagpur |
| Address |
Room No. 22 ,
Government Dental College and Hospital,
GMC Campus , Medical Square , Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
09973094859 |
| Fax |
|
| Email |
srishtysneh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. ASHITA KALASKAR |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
Government Dental College Nagpur |
| Address |
Room No. 25 ,
Government Dental College and Hospital,
GMC Campus , Medical Square , Nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8208487687 |
| Fax |
|
| Email |
kalaskarashita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRISHTY SNEH |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College Nagpur |
| Address |
Room No. 22 ,
Government Dental College and Hospital,
GMC Campus , Medical Square , Nagpur.
MAHARASHTRA
440003
India |
| Phone |
09973094859 |
| Fax |
|
| Email |
srishtysneh@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPART OF ORAL MEDICINE , GOVERNMENT DENTAL COLLEGE AND HOSPITAL , NAGPUR |
| SELF |
|
|
Primary Sponsor
|
| Name |
DR. SRISHTY SNEH |
| Address |
Room No. 22 ,
Government Dental College and Hospital,
GMC Campus , Medical Square , Nagpur. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srishty Sneh |
Government Dental College and Hospital Nagpur |
Room No. 22 ,
Department of Oral Medicine and radiology ,
Government Dental college and Hospital Nagpur , GMC Campus , Medical Square , nagpur -440003
Nagpur
MAHARASHTRA |
09973094859
srishtysneh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GDC NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (3) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (4) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (5) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (6) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (7) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (8) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (9) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (10) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (11) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (12) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (13) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (14) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine (0.5%) |
Bupivacaine (0.5%) is a long acting local anesthetic agent which is given on the muscle trigger points 0n Day 1 and Day 4
1ml of bupivacaine will be given intra-muscular in muscles with trigger point. |
| Comparator Agent |
Lignocaine (2%) |
Lignocaine (2%) is a short acting local anesthetic agent which is given on the muscle trigger points.
1ml of lignocaine will be given intra-muscular in muscles with trigger point 0n Day 1 and Day 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients 18 to 60 years of age (either sex).
Patients will be selected according to Simons Criteria.
History of recurrent or chronic regional musculoskeletal pain in Cranio-facial caused by trigger points.
Pharmacologic washout of ≥72 hours for central analgesics, NSAIDs, and antidepressants
Patients who have given Informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain pressure Threshold
Intensity of Pain
Maximum Mouth Opening |
DAY 1 , DAY 5 , DAY 9 , DAY 15 , DAY 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Myofascial Pain Syndrome (MPS) is a common,
chronic, and regional musculoskeletal condition. MPS are a large group of
muscular disorders, such a syndrome is a disorder concerning the muscle, its
fascia or both and is accompanied by pain in an affected area or a zone of
reference and malfunction of the affected muscle. Management of MPS consists of invasive and non-invasive
treatment interventions, in conjunction with identification and removal of
perpetuating factors. Invasive procedures include dry needling of Muscle Trigger
Points (MTrPs) and injection with botulinum toxin or local anaesthetic agents
such as lidocaine.Traditional approaches to treating MPS have
included like Physical Therapy like stretch and spray, massage, transcutaneous
electrical nerve stimulation, massage, local heat and medications such as Muscle
relaxants , NSAIDS , Tricyclic agents which is considered as a muscle relaxant
with anti-inflammatory and analgesic effects . Amongst the different Treatment Modalities,
According to different studies Trigger Point Therapy is considered to the Gold
standard. Trigger-point injection is indicated for patients who
have symptomatic active trigger points that produce a twitch response to
pressure and create a pattern of referred pain. In comparative studies, dry
needling was found to be as effective as injecting a solution such as lidocaine
or Bupivacaine. However, post injection soreness resulting from
dry needling was found to be more intense and of longer duration than the
soreness experienced by patients injected with local anaesthetic.
Not
much studies have been done to compare two local anaesthetic agents in Trigger
point therapy , therefore this study is being conducted to see the
effectiveness of a long acting local anaesthetic i.e Bupivacaine and a shorter
acting local anaesthetic i.e Lignocaine . |