| CTRI Number |
CTRI/2024/12/077803 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Intra-articular steroids and Suprascapular nerve block for Diabetic frozen shoulder. |
|
Scientific Title of Study
|
Comparison between ultrasound guided Suprascapular nerve block and the combination of Suprascapular nerve block with Intra-articular steroids via anterior Rotator cuff approach for Adhesive capsulitis, in Diabetes mellitus patients. |
| 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 Jessica Khajuria |
| Designation |
3rd Year Post Graduate Resident, Department Of Anaesthesia and Critical Care |
| Affiliation |
Government Medical College, Jammu |
| Address |
Department of Anaesthesiology and Critical Care, Government Medical College, Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9906820748 |
| Fax |
|
| Email |
jessicakhajuria007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Mahajan |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Bakshi Nagar, Jammu |
| Address |
Department of Anaesthesiology and Critical Care, GMC Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419141263 |
| Fax |
|
| Email |
drmahajanr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jessica Khajuria |
| Designation |
3rd Year Post Graduate Resident, Department Of Anaesthesia and Critical Care, GMC Jammu |
| Affiliation |
Government Medical College and Hospital, Bakshi Nagar, Jammu |
| Address |
Department of Anaesthesiology and Critical Care, Government Medical College, Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9906820748 |
| Fax |
|
| Email |
jessicakhajuria007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Bakshi Nagar, Jammu |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital , Bakshi Nagar , Jammu |
| Address |
Maheshpura Chowk, Bakshi Nagar , Jammu 180001 |
| 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 Jessica Khajuria |
Government Medical College and Hospital, Jammu |
Department of Anesthesiology and Critical Care, GMC Jammu, Maheshpura Chowk, Bakshi Nagar, Jammu,180001
Jammu
JAMMU & KASHMIR |
9906820748
jessicakhajuria007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMC Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra articular steroid injection via Anterior rotator cuff approach |
A linear 6-13 MHz US transducer, 22g 9-cm block needle,10ml of 0.25% of Inj. Bupivacaine and 40 mg of Inj. Triamcinolone will be used in all subjects. The patient will lie supine or semi-supine,with the shoulder slightly extended, and the elbow flexed to facilitate visualization of the rotator interval anteriorly. The transducer will be placed over the anterior shoulder, and a long-axis view of the rotator interval, with the biceps at the center of image and supraspinatus and subscapularis to either side, is obtained. The coracohumeral ligament will be seen superiorly over the biceps tendon. Doppler will be done before needling. A 22-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. After aspirating, 10ml of 0.25% of Inj. Bupivacaine and 40 mg of Inj. Triamcinolone will be injected. |
| Intervention |
Suprascapular nerve block |
A linear 6-13 MHz US transducer, 22g 9-cm block needle, 5ml of 0.5% of Inj. Bupivacaine + 10μg of Inj. Dexmedetomidine will be used in all subjects. Patients will be placed in sitting position with their hand reaching to the contralateral shoulder. The transducer will be placed oblique to the spine of scapula in the supraspinous fossa. The SSM muscle, acromian process and trapezius will be identified. The SSN will be located underneath the deep fascia of the SSM and next to the suprascapular artery. Doppler will be done before needling. After skin infilteration with 0.2% lignocaine, the block needle will be advanced from posteromedial to lateral side until the needle is positioned immediately next to the SSN and SSA. 5ml of 0.5% of Inj. Bupivacaine and 10μg of Inj. Dexmedetomidine will be injected after aspirating to prevent vascular entry. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients (18-70 years), diagnosed with controlled type 2 Diabetes Mellitus and clinically diagnosed with Frozen shoulder, with a symptom duration of minimum 3 Months, with no radiographic findings on shoulder radiographs except for
osteoporosis.
2. Informed written consent
3. Either sex
4. Diagnosed as Frozen shoulder; clinically: pain and restriction in ROM (≥ 25% loss of ROM in≥ 2 directions, i.e. abduction, flexion,
extension, external rotation, and internal rotation). |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Other causes of Frozen Shoulder, such as the Concomitant rotator cuff tear, calcific tendinitis, rheumatic diseases and infection
3. Osteoarthritis,
4. History of high-energy trauma,
5. Previous shoulder surgery,
6. Previous Corticosteroid injection on the affected side within 3 months before the visit of our clinic,
7. Incomplete data before the injection and at 3,
6, 9 and 12 Weeks after the injection,
8. Poor cognitive Function
9. Bleeding diathesis
10.Infection at the site of injection
11.Inability to consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate shoulder pain measured by a visual Numeric Pain Rating Scale (NPRS). |
Baseline(before treatment),
after treatment, 3rd week, 6th week, 9th week, 12th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure the functional disability evaluated by SPADI and DASH score.
2. Decreased requirement for additional therapies for frozen shoulder
3. To evaluate passive shoulder ROM by goniometer |
Baseline(before treatment), after treatment, 3rd week, 6th week, 9th week, 12th week. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="0"
Months="10"
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
|
INTRODUCTION:
Frozen shoulder is one of the most common musculoskeletal problems seen in diabetes mellitus patients. Many treatment modalities are available. US guided suprascapular nerve block and Intra-articular steroid injection via Rotator cuff approach is a very common treatment modality. The data on comparative efficacy is however limited. The present study will be done to compare the efficacy of US guided suprascapular nerve block and Intra-articular steroids in the management of painful frozen shoulder. PRIMARY OBJECTIVE: To evaluate shoulder pain measured by Numeric Pain Rating Scale(NPRS). SECONDARY OBJECTIVE: To measure the functional disability evaluated by the SPADI and DASH score. To evaluate passive ROM measured by a goniometer. Decreased requirement for additional therapies for Frozen shoulder
TYPE OF STUDY: Randomised, prospective,single blinded study. |