| CTRI Number |
CTRI/2024/06/068275 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [It is study to compare effectiveness of two types of treatment] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of effectiveness of ultrasound guided trapezius trigger point injection versus combined Ultrasound-Guided Erector Spinae Plane And Trapezius Trigger Block at sms medical college |
|
Scientific Title of Study
|
An Interventional Study to Evaluate Effectiveness of Ultrasound-guided Erector Spinae Plane and Trapezius Trigger Block Versus Trapezius Muscle Injection in Myofascial Pain Syndrome at Department of Physical,medicine and Rehabilitation, Sms Hospital, Jaipur |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshi Panwar |
| Designation |
Junior Resident |
| Affiliation |
SMS Hospital |
| Address |
Department of Physical Medicine and Rehabilitation,sms Medical College,jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7728086830 |
| Fax |
|
| Email |
drhimanshipanwar20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrinal Joshi |
| Designation |
Guide Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation,sms Medical College,jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414057864 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrinal Joshi |
| Designation |
Guide Professor |
| Affiliation |
SMS MEDICAL COLLEGE ,JAIPUR |
| Address |
Department of Physical Medicine and Rehabilitation,sms Medical College,jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414057864 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation,sms
Medical College,302004, Jaipur, Rajasthan,india |
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation,SMS Medical College,Jaipur,Rajasthan
|
| 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 Mrinal Joshi |
SMS hospital |
Outpatient, Department of physical medicine and rehabilitation, SMS Medical college and attached hospital,Jaipur,RAJASTHAN
Jaipur
RAJASTHAN |
9414057864
dr.m.joshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE ETHICS COMITTEE,SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trapezius muscle injection group (Group A) |
With a linear ultrasound transducer, the most painful /tender spot/trigger point of the trapezius muscle will be scanned in the sagittal plane, and the area will then receive an injection (0.25% 5 ml bupivacaine) through the in-plane method on day 15,30 and 45 |
| Comparator Agent |
Trapezius trigger injection and erector spinae plane combined (Group B ) |
The spinous process of T3 is located at the same level/ horizontal plane as the root of the spine of the scapula and under it, the T4 posterior spinous process can be palpated, which also marks the extreme convexity of the thoracic kyphosis. Thus, making it the most prominent spinous process below the root of neck. T4 level will be initially assessed for the erector spinae plane block using a linear ultrasound transducer positioned transversely on the spinous processes.
The hyperechoic transverse process will then be visible when the transducer has been positioned longitudinally for lateral scanning at the level of the T4 spinous process
On the transverse process, from the deep to the surface, you can see the Erector spinae, Rhomboid major, and Trapezius muscles.
Then 20 ml of 0.125% bupivacaine would be injected between the transverse process and the erector spinae muscle using a 90mm,25gauge needle in a caudal to cephalad manner through an in-plane approach and trapezius muscle trigger block will be done as described in Group A intervention on day 15,30 and 45
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) adult patients diagnosed with chronic neck and upper back myofascial pain lasting more than 3 months.
2) presence of at least one trigger point in trapezius muscle.
3) patients willing to give written and informed consent.
4) pain with revised FACES score more than 4 for 3 months |
|
| ExclusionCriteria |
| Details |
Those Having Associated Comorbidity Due to Cervical Radiculopathy, Fibromyalgia, Shoulder Joint Disease, Rheumatic Diseases, Diabetes Mellitus and Malignancy
2.those With Any Other Medical or Surgical Reason That Can Interfere With the Diagnosis and Treatment Protocol.
3.those Who Are Using Anticoagulants or Any Other Blood Thinner.
4.those With a History of Injection for Myofascial Pain Syndrome in the Last Three Months.
5.those With a History of Allergy to Any Component of the Injectate or With Any Medical or Surgical Condition Which Interferes With the Injection Technique.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Revised FACES pain scale and neck disability index |
day 15
day 30
day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
11/06/2024 |
| 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="0"
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
|
In this study our aim is to compare the efficacy of ultrasound-guided combined erector spinae plane and trapezius myofascial trigger block versus trapezius muscle trigger point injection alone in patients with myofascial pain in the neck and upper back when combined with a standard exercise program and oral medication |