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CTRI Number  CTRI/2025/02/081321 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Trigger point injection and Stellate ganglion block in chronic shoulder facial pain in Myofascial Pain Syndrome. 
Scientific Title of Study   Comparative study of trigger point injection versus stellate ganglion block in chronic shoulder-facial myofascial pain syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Manikandan 
Designation  Junior Resident 
Affiliation  Institute Of Medical Sciences, Banaras Hindu University 
Address  Department of Anaesthesiology office, 1st floor,Sir Sunderlal Hospital, Banaras Hindu University,Pandit Madan Malviya Road, Kabir colony.

Varanasi
UTTAR PRADESH
221005
India 
Phone  8807104355  
Fax    
Email  mani.dr.1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Paswan 
Designation  Professor 
Affiliation  Institute Of Medical Sciences 
Address  Department of Anaesthesiology office, 1st floor,Sir Sunderlal Hospital, Banaras Hindu University,Pandit Madan Malviya Road, Kabir colony.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9794855871  
Fax    
Email  dranil1973@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A K Paswan 
Designation  Professor 
Affiliation  Institute Of Medical Sciences 
Address  Department of Anaesthesiology office, 1st floor,Sir Sunderlal Hospital, Banaras Hindu University,Pandit Madan Malviya Road, Kabir colony.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9794855871  
Fax    
Email  dranil1973@gmail.com  
 
Source of Monetary or Material Support  
Sir Sunderlal hospital, Institute of Medical sciences, Banaras Hindu University, Varanasi- 221005 Uttarpradesh. 
 
Primary Sponsor  
Name  Banaras Hindu University 
Address  Department of Anaesthesiology office, 1st floor,Sir Sunderlal Hospital, Banaras Hindu University,Varanasi - 221005 Uttarpradesh. 
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 
Dr J Manikandan  Institute Of Medical Sciences, Banaras Hindu University  Department of Anaesthesiology office, 1st floor,Sir Sunderlal Hospital, Banaras Hindu University,Pandit Madan Malviya Road, Kabir colony.
Varanasi
UTTAR PRADESH 		 8807104355

mani.dr.1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Of Medical Sciences_ethics_committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  stellate ganglion block  The patient would be supine with the neck slightly extended and the head slightly rotated contralaterally to the approached side. After standared aseptic precaution transducer would be placed perpendicular to the tracheal axis at the cricoid cartilage slinding inferiorly until the superior aspect of the thyroid gland is visualized and relocated laterally to the anterior aspect of the Chassaignac’s tubercle on the C6 transverse process. Color Doppler would be used to detect the position of the vessels. With an in-plane approach, the needle would be placed adjacent to trachea , The tip of the neede would be in prevertebral fascia of the Longus colli muscle . Proper positioning of needle would be confirmed by hydrodissection,5ml of a local anesthetic 0.25 % bupivacaine+ dexamethazone would be injected along the paravertebral fascia to the stellate ganglion.The block would also be clinically confirmed by ipsilateral Horners syndrome (ptosis, miosis, and anhydrosis), flushing of the face, and increased temperature of the arm. Dose- 5ml of 0.25% Bupivacaine + 0.1mg per kg dexamethasone. frequency- Single injection. 
Comparator Agent  trigger point injection  After standard aseptic precautions high frequency linear usg probe would be placed in the logitudinal and transverse plane to look for any changes in the muscle underlying the spot marked on the skin. After anaesthetizing the skin with 1% lidocaine, 22g 50mm stimuplex needle would be inserted in to the triggerpoint. Trigger points are hypoechoic in nature.if the needling of suspected visible area reproduced the pain normally experienced by the patient it is called needle sign. Before injecting drug aspiration would be done to ensure that needle is not in the vascular structure. Dose-2-3 ml of 0.25% bupivacaine plus 0.1mg per kg dexamethasone. Frequency- Single dose. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.patients with symptoms for more than 3 months
2.ASA grade 1 and 2 
 
ExclusionCriteria 
Details  1.patients with symptoms less than 3 months
2.ASA grade 3 and more
3.patients with known allergy to local anaesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
visual analogue scale
 		 post procedure outcomes are assessed immediate, 1week, 1month, 3months 
 
Secondary Outcome  
Outcome  TimePoints 
General health questionnaire-(GHQ-12)
 		 post procedure outcomes are assessed immediate, 1week, 1month, 3months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
After the study was approved by the ethical committee members, the patients were
informed about the study procedure and written informed consent was
obtained.Patients suspected to have craniofascial myofascial pain of all degrees of
severity were included. Patients diagnosed by clinical and imaging modalities in pain
OPD of institute of medical sciences -banaras hindu university.The patient’s vital
signs should be monitored before and immediately following the procedure.
A peripheral venous catheter should be placed in all patients. It is important to obtain
a detailed medical history before the procedure to rule out any contraindications and
evaluate the risk/benefits ratio.

1.USG GUIDED TRIGGER POINT INJECTION

After standard aseptic precautions high frequency linear usg probe would be placed
in the logitudinal and transverse plane to look for any changes in the muscle
underlying the spot marked on the skin. After anaesthetizing the skin with 1%
lidocaine, 22g 50mm stimuplex needle would be inserted in to the triggerpoint.
Trigger points are hypoechoic in nature.if the needling of suspected visible area
reproduced the pain normally experienced by the patient it is called needle sign.
Before injecting drug aspiration would be done to ensure that needle is not in the
vascular structure. Then 2-3 ml of bupivacaine 0.25% with dexamethazone 0.1mg/kg
would be injected into the trigger point.

2.USG GUIDED STELLATE GANGLION BLOCK

The patient would be supine with the neck slightly extended and the head slightly
rotated contralaterally to the approached side. After standared aseptic precaution
transducer would be placed perpendicular to the tracheal axis at the cricoid cartilage
slinding inferiorly until the superior aspect of the thyroid gland is visualized and
relocated laterally to the anterior aspect of the Chassaignac’s tubercle on the C6
transverse process. Color Doppler would be used to detect the position of the vessels.
With an in-plane approach, the needle would be placed adjacent to trachea , The tip of
the neede would be in prevertebral fascia of the Longus colli muscle . Proper
positioning of needle would be confirmed by hydrodissection,5ml of a local
anesthetic 0.25 % bupivacaine+ dexamethazone would be injected along the
paravertebral fascia to the stellate ganglion.The block would also be clinically
confirmed by ipsilateral Horner’s syndrome (ptosis, miosis, and anhydrosis), flushing
of the face, and increased temperature of the arm.
 
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