| CTRI Number |
CTRI/2026/02/102745 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing ultrasound-guided and landmark-guided shoulder injection in patients with frozen shoulder |
|
Scientific Title of Study
|
Ultrasound-guided versus landmark-guided suprascapular nerve block in periarthritis shoulder: A prospective randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANANYA GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT. OF PMR, RALC BUILDING, KGMU, LUCKNOW
ROOM NO. 9, NEHRU PG HOSTEL, KGMU
Lucknow
UTTAR PRADESH
226018
India |
| Phone |
7500800102 |
| Fax |
|
| Email |
ananyagfzd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANANYA GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT. OF PMR, RALC BUILDING, KGMU, LUCKNOW
ROOM NO. 9, NEHRU PG HOSTEL, KGMU
UTTAR PRADESH
226018
India |
| Phone |
7500800102 |
| Fax |
|
| Email |
ananyagfzd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANANYA GUPTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT. OF PMR, RALC BUILDING, KGMU, LUCKNOW
ROOM NO. 9, NEHRU PG HOSTEL, KGMU
UTTAR PRADESH
226018
India |
| Phone |
7500800102 |
| Fax |
|
| Email |
ananyagfzd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, KGMU, Lucknow, UP, India, 226018 |
|
|
Primary Sponsor
|
| Name |
Department of Physical Medicine and Rehabilitation |
| Address |
Department of Physical Medicine and Rehabilitation, KGMU, Lucknow, UP, India, 226018 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Ananya Gupta |
King Georges Medical University |
Room No. 6, Department of Physical Medicine and Rehabilitation
Lucknow
UTTAR PRADESH |
7500800102
ananyagfzd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Landmark Guided Suprascapular Nerve Block |
Landmark Guided Suprascapular Nerve Block in Periarthritis Shoulder Using Injection Triamcinolone 40mg Stat and total duration of follow up is 6 weeks. |
| Intervention |
Ultrasound Guided Suprascapular Nerve Block |
Ultrasound Guided Suprascapular Nerve Block in Periarthritis Shoulder Using Injection Triamcinolone 40mg Stat and total duration of follow up is 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Complaints of spontaneous onset of shoulder pain and stiffness for four weeks along with night pain that was interfering with sleep and painful restriction of both active and passive shoulder abduction and external rotation (ER) of more than 50 percent of the normal range with no joint crepitus on examination of the joint and had a normal glenohumeral joint X-ray.
2. Consenting to participate.
|
|
| ExclusionCriteria |
| Details |
1. Tear of rotator cuff on clinical/radiological examination.
2. Traumatic or degenerative pathology of shoulder joint.
3. Any chronic neurological disorder
4. Local corticosteroid injection to shoulder joint within the last 3 weeks.
5. Any surgical intervention, dislocations, fractures in the affected
shoulder.
6. History of past or concurrent malignancy.
7. Poorly controlled Diabetes Mellitus.
8. Patient with cholecystitis and sub-diaphragmatic disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare pain relief at defined follow-up intervals using the Numeric Pain Rating Scale (NPRS) in both groups after intervention. |
immediately (post intervention), at 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare improvement in functional outcomes using the Shoulder Pain and Disability Index (SPADI) in both groups after intervention.
2. To evaluate and compare complications or adverse effects in both groups after intervention.
|
immediately (post intervention), at 2 weeks and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/02/2026 |
| 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="6"
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
|
This study is prospective randomized, parallel group, single centered, comparing the efficacy of ultrasound guided and landmark guided suprascapular nerve block in periarthritis shoulder using injection triamcinolone . the primary outcome is to assess and compare
pain relief at defined follow-up intervals using the Numeric Pain Rating Scale (NPRS) in both groups after
intervention. The secondary outcome measure will be to compare improvement
in functional outcomes using the Shoulder Pain and Disability Index (SPADI) in
both groups after intervention and to evaluate and
compare complications or adverse effects in both groups after intervention. The defined follow up interval is immediate post procedure, 2 weeks and 6 weeks |