| CTRI Number |
CTRI/2025/02/080936 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of shoulder block before hydro dilatation in frozen shoulder |
|
Scientific Title of Study
|
A randomized controlled study to evaluate the effect of suprascapular nerve block on procedural pain of hydrodilatation of the shoulder capsule in cases of primary frozen shoulder in Sawai Man Singh Medical College |
| 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 Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital. |
| Address |
Department of Anaesthesia,
Second floor, OT Complex, Dhanwantri building.
Sawai Man Singh Medical College and Attached Hospital.
Jaipur
RAJASTHAN
302004
India |
| Phone |
09680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital. |
| Address |
Department of Anaesthesia,
Second floor, OT Complex, Dhanwantri building,
Sawai Man Singh Medical College and Attached Hospital.
RAJASTHAN
302004
India |
| Phone |
09680565399 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivedita |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital. |
| Address |
Department of Anaesthesia,
Second floor, OT Complex, Dhanwantri building,
Sawai Man Singh Medical College and Attached Hospital.
Jaipur
RAJASTHAN
302004
India |
| Phone |
08445465049 |
| Fax |
|
| Email |
nivedita486@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur, Pin code-302004, Rajasthan,
India. |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 |
| 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 Samridhi Nanda |
Pain OT , SMS Hospital, Jaipur |
Department of Anaesthesia,Second floor,Dhanwantri building,
Sawai Man Singh Medical College and Attached Group of Hospitals,
Jaipur,
Rajasthan
Jaipur
RAJASTHAN |
09680565399
samridhinanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydro dilatation only |
Patients will directly be subjected to hydro dilatation of the shoulder capsule with 10ml of lidocaine 1% and 40 mg of Methyl prednisolone. No supra scapular nerve block will be administered. Pain will be assessed and compared on visual analog scale before starting the procedure, immediately after the procedure and 30 minutes later. |
| Intervention |
Supra scapular nerve block followed by
Hydro dilatation |
Patients will receive suprascapular nerve block with 5ml 1% lidocaine and 20 mg of methylprednisolone followed 5 minutes later by hydro dilatation of the shoulder capsule with 10ml of lidocaine 1% and 40mg of methyl prednisolone and pain is assessed and compared on Visual analog scale, before beginning the procedure, immediately after the procedure and 30 minutes later. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with primary frozen shoulder and managed conservatively with pharmacotherapy +_ physical therapy for more than 3 months.
Patients giving informed written consent.
Patients coming in to ASA grade I,II.
Patients should not be part of any other study. |
|
| ExclusionCriteria |
| Details |
Patients with the history of coagulopathy or are on blood thinning medications at the time of the procedure.
Patients who have a history of shoulder surgery, breast surgery, fracture around the shoulder and upper extremities, have a history of cerebrovascular disease, cervical radiculopathy.
Patients who have secondary and tertiary frozen shoulder including extra capsular pathology.
Patients having uncontrolled diabetes mellitus, thyroid disorders or other systemic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate the effect of suprascapular nerve block on procedural pain using VAS, during hydrodilatation of the shoulder capsule between the two groups. |
1.VAS at the time of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the effect of suprascapular nerve block on shoulder pain at rest using VAS between two groups.
2. To assess and compare the effect of suprascapular nerve block on shoulder pain and disability using SPADI score between study groups.
3.To assess and compare the effect of suprascapular nerve block on different ranges of motion of shoulder(Flexion,Extension,Abduction,Adduction,internal rotation and external rotation) using goniometer.
4.To determine the complications/side effects of the procedure, if any.
|
1. VAS before begining
the procedure,immediately after the hydrodilatation and after 30 minutes.
2. Using SPADI before the procedure and at 15 days.
3.Using Goniometer at baseline, immediadiately after the hydrodilatation, and after 15 minutes.
4.To observe the complications or side effects,if any. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="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
|
Frozen shoulder, also known as
adhesive capsulitis, has a prevalence of 2-5% in the general population and is
considered to be one of the most serious painful conditions involving the
musculoskeletal system.
It is characterised by the
formation of scar tissue, adhesions and capsular thickening within the shoulder. This results in symptoms of localized pain and
restricted range of motion.
Despite
much research and advocation for treatment modalities such as corticosteroid
injections, mobilizations and acupuncture, optimal management protocol for AC
is not clearly defined, with no specific guidelines for clinicians to follow
when faced with a patient.
Hydro dilatation of the
shoulder joint capsule is a novel treatment to alleviate the pain of the
applied shoulder. Hydro dilatation consists of injecting
fluid in the glenohumeral joint under fluoroscopic control to rupture the
capsule to increase the shoulder’s mobility.
It
is an easy, safe, and cost-effective method to treat frozen shoulder in terms
of functionality and pain relief.
The
hydro dilatation method can cause pain in the shoulder during the intervention,
so early manual exercise after the intervention is required to inhibit pain.
Suprascapular
nerve block (SSNB) has been found effective in reducing pain originating from
the shoulder joint including that in FS.
The
suprascapular nerve supplies 70% of the sensory nerve supply to the shoulder
joint, and local anesthetic block of this nerve is effective in certain
shoulder pain disorders.
The
literature comparing the efficacy of SSNB used as an adjunct in hydro
dilatation of frozen shoulder remains sparse.
Therefore,
this study aims to understand the effects of the SSNB on procedural pain of
hydro dilatation of the shoulder capsule in case of AC. |