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CTRI Number  CTRI/2024/06/068647 [Registered on: 10/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomised Single Blinded Study Comparing Between Ultrasound Guided Trigger Point Injection Versus Trapezius Plane Block As Treatment Modalities In Patients With Myofascial Pain Syndrome 
Scientific Title of Study   Comparative Evaluation Of Ultrasound Guided Trigger Point Injections Versus Trapezius Plane Block In Myofascial Pain Syndrome Patients In Terms Of Pain Relief And Quality Of Life 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shobika S 
Designation  Postgraduate Junior Resident 
Affiliation  All India Institute Of Medical Sciences Raipur  
Address  Department Of Anaesthesiology, A Block OT Complex, Fourth Floor, AIIMS Raipur,GE Road, Tatibandh,Raipur,Chhattisgarh
All India Institute Of Medical Sciences Raipur,Tatibandh,GE Road,Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9381055754  
Fax    
Email  shobivarshu2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rampal Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences Raipur  
Address  Department Of Anaesthesiology, A Block OT Complex, Fourth Floor, AIIMS Raipur,GE Road, Tatibandh,Raipur,Chhattisgarh
All India Institute Of Medical Sciences Raipur,Tatibandh,GE Road,Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9027335921  
Fax    
Email  drrampalsingh@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Shobika S 
Designation  Postgraduate Junior Resident 
Affiliation  All India Institute Of Medical Sciences Raipur  
Address  Department Of Anaesthesiology, A Block OT Complex, Fourth Floor,AIIMS Raipur,GE Road, Tatibandh,Raipur,Chhattisgarh
All India Institute Of Medical Sciences Raipur,Tatibandh,GE Road,Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9381055754  
Fax    
Email  shobivarshu2020@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, All India Institute of Medical Sciences, Raipur 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Raipur  
Address  Operation Theatre Complex A Block Fourth Floor All India Institute Of Medical Sciences Raipur, Tatibandh, GE Road, Raipur, Chhattisgarh 492099 
Type of Sponsor  Government medical college 
 
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 Shobika S  All India Institute Of Medical Sciences Raipur  Operation Theatre Complex A Block Fourth Floor All India Institute Of Medical Sciences Raipur, Tatibandh, GE Road, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
9381055754

shobivarshu2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee, All India Institute Of Medical Sciences Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M791||Myalgia, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided Trapezius plane block  Under aseptic conditions, parts will be painted and draped. Under ultrasound guidance, using high frequency (10-15 mHz) linear probe, Spinous process and transverse processes of T4 level of vertebra will be visualised by placing the linear USG probe transversely and longitudinally respectively. Erector spinae, rhomboid major and trapezius muscles will be visualised from deep to surface. A 22 Gauge Quincke needle will be inserted 2-3 cm away along the axis of the probe and advanced by an in-plane technique until it reaches the transverse process. After ensuring the needle is in place and negative aspiration, 0.25% bupivacaine with 80 mg of Triamcinolone will be injected into the interfascial plane between the erector spinae muscle and T4 transverse process, under the superficial fascial plane of trapezius muscle, about 3 to 5 cm lateral from the midline where the dorsal rami of the spinal nerves emerge.  
Intervention  Ultrasound Guided Trigger Point Injections  Under Ultrasound Guidance, using a high frequency (10-15 mHz) linear probe, the trigger points will be visualised. After anaesthetising the skin with 1% lidocaine, 23 gauge spinal needle is used, Using the In- plane technique, Needle will be inserted 1 to 2 cm away from the trigger point so that the needle will be advanced into the trigger point at an acute angle of 30 degrees to the skin. Once ensuring the needle is in place and confirming with negative aspiration, A total of 80 mg of Inj. Triamcinolone and 3 to 4 ml of 0.25% Bupivacaine in each trigger point not exceeding more than 20 ml. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with myofascial pain syndrome with pain over neck or shoulders with clinically detectable trigger points
2.Patients who have given consent for study.
3.ASA grade 1 and 2
4.Patients with NRS pain scale of more than 4 out of 10
5.Patients with no motor deficits or congenital or systemic pathology
6.Patients with pain refractory to routine analgesics and physiotherapy. 
 
ExclusionCriteria 
Details  1.Patients who did not give consent
2.Patients who are less than age of 20 years and above 70 years of age
3.ASA grade 3 or more
4.Patients who are allergic to steroids or local anaesthetics
5.Patients who have trigger points other than neck and shoulder region
6.Patients with NRS pain scale less than 4 out of 10
7.Patients with motor deficits, congenital or systemic pathologies.
8.Patients with any local infection, coagulation abnormalities
9.Patients in whom routine analgesics have produced desired analgesic effect 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Postprocedural pain intensity will be measured by NRS pain scale at every 3 weeks for first 3 visits and duration for which patient is relatively pain free  every 3 weeks for first 3 visits 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of life using Quality of life ,Enjoyment and Satisfaction questionnaire- short form (Q-LES-Q-SF questionnaire)  Every 3 weeks for 3 visits 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   21/06/2024 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drshobika2020@gmail.com].

  6. For how long will this data be available start date provided 31-05-2024 and end date provided 31-05-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After detailed history and clinical examination, patients will be admitted on IPD basis and written informed consent will be obtained. Patients will be asked to pick a number on the random number table and will be assigned to either Group I or Group B.
Patients will be tested for any drug reactions for Lignocaine or bupivacaine with subcutaneous injection of 0.1ml using an insulin syringe.
Patient will be instructed to be Nil Per Oral for 6 hours for solid food and 2 hours for clear liquids.
Equipments needed: Sterile gloves, Gauze, Alcohol pads, 2ml, 5ml and 10 mL Syringes, 21-25 G spinal quincke needles (used depending on location of TP and body habitus ), Adhesive bandage, Surgical Marker, 2% lidocaine, Triamcinolone 40 or 80mg and 0.25% bupivacaine.
After Checking Ambu bag, defibrillator, crash cart and airway trolley and Anesthesia machine check, Patient will be shifted to the operating room, attached with standard monitors (ECG, Non invasive BP and Peripheral oxygen Saturation probe), intravenous cannula secured and patient will be positioned in prone position
Procedure for Patient assigned into Group I : Trigger point injection:
Under aseptic conditions, parts will be painted and draped. Under ultrasound guidance, using a high frequency (10-15 mHz) linear probe, the trigger points will be visualised. After anaesthetising the skin with 1% lidocaine, 23 gauge spinal needle is used,
Using the In- plane technique, Needle will be inserted 1 to 2 cm away from the trigger point so that the needle will be advanced into the trigger point at an acute angle of 30 degrees to the skin. Once ensuring the needle is in place and confirming with negative aspiration, A total of 80 mg of Inj.
Triamcinolone and 3 to 4 ml of 0.25% Bupivacaine in each trigger point not exceeding more than 20 ml. Adhesive bandage will be applied and the patient will be asked to stretch the muscle and NRS pain scale will be assessed 5 mins after the end of the procedure.
Procedure for Patient assigned into Group B: Trapezius plane block:
Under aseptic conditions, parts will be painted and draped. Under ultrasound guidance, using high frequency (10-15 mHz) linear probe, Spinous process and transverse processes of T4 level of vertebra will be visualised by placing the linear USG probe transversely and longitudinally respectively.
Erector spinae, rhomboid major and trapezius muscles will be visualised from deep to surface. A 22 gauge Quincke needle will be inserted 2-3 cm away along the axis of the probe and advanced by an in-plane technique until it reaches the transverse process. After ensuring the needle is in place and negative aspiration, 0.25% bupivacaine with 80 mg of Triamcinolone will be injected into the interfascial plane between the erector spinae muscle and T4 transverse process, under the superficial fascial plane of trapezius muscle, about 3 to 5 cm lateral from the midline where the dorsal rami of the spinal nerves emerge. Adhesive bandage will be applied and patient will be asked to stretch the muscle and NRS pain scale will be assessed 5mins after the end of the procedure.

Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) Taking everything into consideration, during the past week how satisfied have you been with your……… Very Poor Poor Fair Good Very Good …..physical health? 1 2 3 4 5 …..mood? 1 2 3 4 5 …..work? 1 2 3 4 5 …..household activities? 1 2 3 4 5 …..social relationships? 1 2 3 4 5 …..family relationships? 1 2 3 4 5 …..leisure time activities? 1 2 3 4 5 …..ability to function in daily life? 1 2 3 4 5 …..sexual drive, interest and/or performance?* 1 2 3 4 5 …..economic status? 1 2 3 4 5 …..living/housing situation?* 1 2 3 4 5 …..ability to get around physically without feeling dizzy or unsteady or falling?* 1 2 3 4 5 …..your vision in terms of ability to do work or hobbies?* 1 2 3 4 5 …..overall sense of well being? 1 2 3 4 5 …..medication? (If not taking any, check here and leave item blank.) 1 2 3 4 5 …..How would you rate your overall life satisfaction and contentment during the past week? 1 2 3 4 5 *If satisfaction is very poor, poor or fair on these items, please UNDERLINE the factor(s) associated with a lack of satisfaction. 
 
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