| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshobika2020@gmail.com].
- 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.
- 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. |