| CTRI Number |
CTRI/2025/07/090431 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to study the the effect and advantages of Intra-articular Steroid Injections over Pericapsular Nerve Group (PENG) Block injection for the treatment of shoulder pain. |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the Efficacy of Intra-articular Steroid Injection and Pericapsular Nerve Group (PENG) Block for Pain Control and Functional Outcomes in Patients Undergoing Manipulation Under Anesthesia (MUA) for Frozen Shoulder. |
| 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 Sangeeta Dhanger |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College & Research Institute |
| Address |
Hospital Block Ground floor OT complex department of anaesthesiology Indira Gandhi Medical College & Research Institute Puducherry
Pondicherry
PONDICHERRY
605002
India |
| Phone |
848165915 |
| Fax |
|
| Email |
drsangeeta06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Dhanger |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College & Research Institute |
| Address |
Hospital Block Ground floor OT complex department of anaesthesiology Indira Gandhi Medical College & Research Institute Puducherry
PONDICHERRY
605002
India |
| Phone |
848165915 |
| Fax |
|
| Email |
drsangeeta06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Dhanger |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College & Research Institute |
| Address |
Hospital Block Ground floor OT complex department of anaesthesiology Indira Gandhi Medical College & Research Institute Puducherry
PONDICHERRY
605002
India |
| Phone |
848165915 |
| Fax |
|
| Email |
drsangeeta06@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology Indira Gandhi Medical College & Research Institute Kadhirkamam Valzhavur road Puducherry 605002 |
|
|
Primary Sponsor
|
| Name |
Deaparment of anestehsiopgy |
| Address |
Hospital block Ground floor Department of Anaesthesiology Indira Gandhi Medical College & Research Institute Kadhirkamam Valzdhavur road Pondicherry |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Depart of Orthopediac and Rehabilitation |
Hospital block Ground floor Department of Anaesthesiology ndira Gandhi Medical College & Research Institute Kadhirkamam Valzdhavur road Pondicherry |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prateeba Netrajan |
Indira Gandhi Medical College & Research Institute |
Hospital block Ground floor Department of Anaesthesiology Indira Gandhi Medical College & Research Institute Kadhirkamam Valzdhavur road Pondicherry
Pondicherry
PONDICHERRY |
8489265925
drpratheebark@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (3) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra-articular Steroid Injection |
(Intra-articular Steroid Injection Under sterile conditions, a corticosteroid (inj Triancinolone 40mg) with 2%2ml and 0.5% Bupivacine 2ml will be injected into the pericapsular region under ultrasound guidance.
Injection will be administered immediately before the MUA procedure |
| Comparator Agent |
PENG Block |
The PENG block will be performed under ultrasound guidance targeting the articular branches of the shoulder joint.
• A local anaesthetic (e.g., 0.5% bupivacaine 10 mL+2% Lidocaine 10ml ) will be used, and the block will be performed prior to MUA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Candidates for MUA based on clinical evaluation and failure of conservative management
Willingness to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to regional anesthesia or steroid use (e.g., infections, allergy, coagulopathy).
2. Previous shoulder surgery or trauma.
3. Neurological or other musculoskeletal disorders affecting shoulder function.
4. Pregnancy or lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain reduction (NPRS) within 24 hours post-MUA.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in shoulder ROM from baseline to post-MUA & follow-up visits. Functional improvement as measured by SPADI scores.Duration of analgesia.
Incidence of complications or adverse effects.
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Patients satisfying the inclusive criteria will be prepared for procedure with standard monitoring. Randomization will be done by computer generated random number and allocation will be done by Sequentially numbered, opaque, sealed envelope (SNOSE technique), the randomization group is written on a paper and is kept in an opaque sealed envelope. The envelope is labeled with a serial number by a person who is not part of the study. The envelope will be opened, and the group will be allocated by staff nurse who is not the part of the study.The following procedure will be performed by an Anesthesiologist who has 5 years experience with Ultrasound usage.The outcomes will be recorded by the Anaesthesiologist. Group A (Intra-articular Steroid Injection Under sterile conditions, a corticosteroid (inj Triancinolone 40mg) with 2%2ml and 0.5% Bupivacine 2ml will be injected into the pericapsular region under ultrasound guidance. Injection will be administered immediately before the MUA procedure Group B (PENG Block): The PENG block will be performed under ultrasound guidance targeting the articular branches of the shoulder joint. A local anaesthetic (e.g., 0.5% bupivacaine 10 mL+2% Lidocaine 10ml ) will be used, and the block will be performed prior to MUA.
Study Procedure
1. Baseline Assessment: o Pain assessment (NPRS).
o Range of motion (ROM) measurements.
o Functional assessments using SPADI scores. 2. Randomization:
o Patients will be randomly assigned to one of the two intervention groups. o Randomization will be conducted using a computer-generated sequence. o AllocationwillbedonebySequentiallynumbered,opaque,sealedenvelope(SNOSE technique) o Its Superior Trial
o NoBlindinginthisstudy
o Withdrawncriteria:Failureofblock,patientrefusedaftertheconsentandorlossoffollow- up the patient
o Rescuecriteria:ifpatientisnotsatisfiedwiththepainrelieswillRefertotheOrtho department for the surgical intervention. o CTRI:applied 3. Intervention:
o Pericapsular steroid injection or PENG block will be administered prior to MUA. 4. Post-MUA Assessments: o Pain: NPRS scores will be recorded at 1 hour, 6 hours, 12 hours, and 24 hours post- procedure. o ROM: Shoulder ROM will be assessed immediately post-procedure and at follow-up visits. o Functional outcomes: SPADI scores will be assessed at24 hrs 1 week and 1 month post- procedure. o Duration of analgesia and any complications will be documented. 8. Outcome Measures Primary Outcome:
• Pain reduction (NPRS) within 24 hours post-MUA. Secondary Outcomes: Change in shoulder ROM from baseline to post-MUA and follow-up visits. Functional improvement as measured by SPADI scores. Duration of analgesia. Incidence of complications or adverse effects.
|