| CTRI Number |
CTRI/2025/07/091074 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain relief and shoulder movement recovery after shoulder manipulation using two different nerve blocks in patients with frozen shoulder. |
|
Scientific Title of Study
|
Pain Relief and Functional Recovery After Shoulder Manipulation
Under Interscalene vs. Combined Suprascapular and Axillary Nerve
Blocks in Frozen Shoulder: A Randomized non inferiority Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Dutta |
| Designation |
junior resisdent |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Department of anaethesia, Dhanvanthri Nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
08810431018 |
| Fax |
|
| Email |
dr.anji23d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan VK |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaethesia, Dhanvanthri Nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9841546265 |
| Fax |
|
| Email |
drmohanvk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaethesia, Dhanvanthri Nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786668202 |
| Fax |
|
| Email |
dr.ramyaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,India,Puduchhery,605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER, Dhanvanthri Nagar,Puducherry ,605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjali dutta |
Jawaharlal institute of postgraduate,Medical Education and Research |
Department of anaethesia, Dhanvanthri Nagar,Puducherry Anaethesia office ,old building 2nd floor
Pondicherry
PONDICHERRY |
08810431018
dr.anji23d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Interventional studies JIPMER,Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA1 and ASA2
DONT HAVE ANY PERVIOUS SHOULDER SURGERY FOR PATIENT |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pain Relief and Functional Recovery After Shoulder Manipulation Under Interscalene vs. Combined Suprascapular and Axillary Nerve Blocks in Frozen Shoulder: A Randomized non inferiority Trial |
patients are divided in two Group 1
Patient receiving combined suprascapular and axillary nerve group Suprascapular block will be done at suprascapular notch 5ml of 5% bupivacaine axillary nerve block at quadrilateral space with 5ml of 0.5 % bupivacaine.
Group 2
Patient receiving interscalene nerve block alone.
Interscalene brachial plexus block with 10ml of 0,5% bupivacaine
both group Shoulder manipulation by using Codmans Paradox
Patient of both group will be given intra articular Methylprednisolone injection 40mg in volume of 10ml after shoulder manipulation by using Codman’s paradox.
Clinical Assessment by using Likert Scale,SPADI, and Constant -Murley Shoulder outcome score will be noted after 4hr of procedure patient reviewed after 1 month |
| Comparator Agent |
unaffected arm |
unaffected arm compare rangeof motion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years to70 years.
2. ASA class 1 & 2
3. Patients diagnosed with frozen shoulder having
shoulder pain and reduced range of motion for 3
months |
|
| ExclusionCriteria |
| Details |
1. Previous shoulder surgery
2. Interventional pain procedures for shoulder pain in
the last 6 months
3. Cervical spine disease
4. Patients suspected with rotator cuff injuries
5. Bleeding disorders
6. Allergy to the local Anesthetics
7. Local site infection |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in SPADI score after 4weeks month following
shoulder manipulation |
SPADI score at Baseline and 4 weeks month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the satisfaction of the clinician performing the after 4 hr
shoulder manipulation using a Likert scale
2. To compare the change in SPADI score & Constant
Murley Shoulder outcome on the day of procedure
3. To compare the change in Constant-Murley Shoulder
outcome score at 1 month |
then follow up after 1 month |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
27/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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 obtaining approval from the Post-graduate Research Monitoring Committee and JIPMER ethics committee (human studies), and completing Clinical Trial Registry India(CTRI) registration, patients fulfilling the eligibility criteria will be recruited for the study after obtaining written informed consent. Baseline recording of SPADI score, Constant Murley Shoulder outcome score will be taken. The patients will be randomly allocated into 2 groups, Group 1 (receiving Suprascapular nerve block and axillary nerve block), Group 2 (interscalene nerve block alone) . Prior to any intervention, the patient will be assessed with Shoulder Pain and Disability score (SPADI) and Constant-Murley Shoulder outcome score. (6) . The need for pain medication will be assessed using the Medication Quantification Scale (MQS III). All standard ASA monitors including non-invasive blood pressure, pulse oximetry, ECG will be attached. Baseline hemodynamic parameters like heart rate, blood pressure and spo2 will be recorded. An appropriately sized IV cannula will be secured. Patients belonging to Group 1 will receive ultrasound guided Suprascapular nerve block and axillary nerve block. With the patient in sitting position, Suprascapular nerve will be blocked at the level of suprascapular notch with 5 ml of 0.5%Bupivacaine after identifying the suprascapular artery using doppler. Axillary nerve is blocked at the quadrilateral space with 5 ml of 0.5%Bupivacaine after identifying the posterior circumflex humeral artery. Patients belonging to group 2 will receive ultrasound guided Interscalene brachial plexus blocks with 10 ml of 0.5% Bupivacaine, with the patient in supine position and head turned slightly to the opposite side. Blocks will be performed by a person who has done at least 50 USG guided nerve blocks. After 15 minutes of giving the block, Orthopedic surgeon/ Physical therapist involved in the study will do the shoulder manipulation using Codman’s paradox method. One orthopaedic surgeon and one physical therapist have been involved in the study and the manipulation will be done by one of them. It includes three consecutive 90° rotations - elevation, swing, and descending movements. (1) Starting position: The patient hangs his or her arm along the side with the thumb pointing forward and fingers pointing toward the ground. (2) Elevation (first move): The arm is elevated 90° in the sagittal plane without rotation about the humeral shaft axis (i.e. thumb points upward and fingers point forward). (3) Swing (second move): The arm is moved 90° to the coronal plane without rotation about the humeral shaft axis (i.e. fingers now point to the right or left for the right and left shoulders, respectively). (4) Descending (third move): Finally, the arm is lowered 90° downward (i.e. fingers point to the ground). After these three rotations, the patient will notice that the thumb points to the right or left (for the right and left shoulders, respectively), which means that the arm has rotated by 90°. Patients in both groups will be given intraarticular Methylprednisolone injection 40 mg in volume of 10 ml after the shoulder manipulation.Clinician assessment Patients will be observed until the block effect wears out. Any complications will be noted and satisfactory manipulation using Likert scale will be noted. SPADI and Constant-Murley Shoulder outcome score will be noted after 4 hours of the procedure. Patients will be advised to continue physiotherapy and RoM exercises. Patients will be reviewed every week on telephone to motivate them to continue physiotherapy. After 1 month the patient will be reviewed in pain clinic to assess SPADI, Constant-Meyer Shoulder outcome score and pain medication requirement using MQS III scale will be noted. |