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CTRI Number  CTRI/2025/06/089189 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A Randomised controlled study on outcome of Intrarticular steroid injection verses Intraarticular steroid injection with Manipulation under Anaesthesia for treating unilateral Frozen shoulder 
Scientific Title of Study   A Randomised controlled study on outcome of Intrarticular steroid injection versus Intraarticular steroid injection with Manipulation under Anaesthesia for treating unilateral 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 P K Raju 
Designation  Hod of orthopaedics 
Affiliation  BMCRI  
Address  Department of orthopaedics Professor and HOD Room no : B block ( No 16) Head of the department Victoria hospital , KR ROAD ,KALASIPALYA ,BENGALURU

Bangalore
KARNATAKA
560002
India 
Phone  8904572313  
Fax    
Email  kvpkr@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P K Raju 
Designation  Hod of orthopaedics 
Affiliation  BMCRI  
Address  Department of orthopaedics Professor and Head of the department Room no : B block (no 16) Bangalore medical college and research institute , KR ROAD ,KALASIPALYA ,BENGALURU -560002

Bangalore
KARNATAKA
560002
India 
Phone  8904572313  
Fax    
Email  kvpkr@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P K Raju 
Designation  Hod of orthopaedics 
Affiliation  BMCRI  
Address  Department of orthopaedics Professor and HOD Room no : B block (No 16) Bangalore medical college and research institute , KR ROAD ,KALASIPALYA ,BENGALURU -560002

Bangalore
KARNATAKA
560002
India 
Phone  8904572313  
Fax    
Email  kvpkr@rediffmail.com  
 
Source of Monetary or Material Support  
Victoria hospital KR road , city market , Kalasipalya , Bangalore-560002 
 
Primary Sponsor  
Name  Self 
Address  Victoria Hospital /Bangalore medical college and research institute . K r road , city market , kalasipalya , India , karnataka, Bengaluru-560002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suhas R  Victoria hospital  Department of orthopaedics ,B block Address : K R road near city market, kalasipalya, Bangalore -560002
Bangalore
KARNATAKA 		 7019528919

suhaspadma88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Bangalore Medical College and Research Institute,Bengaluru.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intraarticular steroid injection   Patients satisfying inclusion criteria will be numbered and allocated in one of the two groups with odd numbered patients in Group A and even numbered patients in Group B. 52 patients of either sex will be randomly allocated to either of two study groups of 26 each A proforma will be used to collect the data which includes patient’s particulars, indication for manipulation, the anaesthetic details, intraoperative monitoring etc. Group B will be patients to be kept fasting overnight, patients will be given Tablet Alprazolam 0.5 mg on the previous night of surgery. Group A patients will be administered 40mg of methyl prednisolone through intraarticular route  
Intervention  manipulation under anaesthesia with intraarticular steroid injection  Patients satisfying inclusion criteria will be numbered and allocated in one of the two groups with odd numbered patients in Group A and even numbered patients in Group B. 52 patients of either sex will be randomly allocated to either of two study groups of 26 each A proforma will be used to collect the data which includes patient’s particulars, indication for manipulation, the anaesthetic details, intraoperative monitoring etc. Group B will be patients to be kept fasting overnight, patients will be given Tablet Alprazolam 0.5 mg on the previous night of surgery. Group A patients will be administered 40mg of methyl prednisolone through intraarticular route .  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Atleast 3 month history of unilateral shoulder pain and stiffness with normal imaging studies
2) The passive shoulder movement with a reduction of more than 30 degree in atleast 2 planes when compared with oppposite side
3) Refractory to conservative treatments , such as medications and physiotherapy 
 
ExclusionCriteria 
Details  1)Age less than 40 years or older than 80 years
2)Infection at the site of injection
3)Patients on oral corticosteroids and having hypersensitivity reactions
4)Patients with severe osteoporosis  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. At each subsequent visiting on 2,4,6,8,10 and 12week ,4, 5 and 6months after first intervention, pain intensity and activities of daily living , movements and strength will be evaluated by the Constant Murley Score.  Baseline at 2weeks and them at 4,6,8,10 and 12week ,4, 5 and 6months  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the range of movements in each & every follow up visits  Baseline at 2weeks, & then at 4,6,8,10,12 weeks , 4, 5 & 6th month . 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/06/2025 
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)   Open to Recruitment 
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   1)The Patient fulfilling the inclusion criteria will be enrolled for the study after obtaining informed written consent.
2)Patients satisfying inclusion criteria will be numbered and allocated in one of the two groups with odd numbered patients in group A and even numbered patients in group B .
3)52 patients of either sex will be randomly allocated to either of two study groups of 26 each as described .
4)A proforma will be used to collect the data which includes patients particulars , indication for manipulation , the anesthesia details , intraoperative monitoring etc., 
5)Group A will be administered 40mg of methyl prednisolone through intraarticular route
6)Group B will undergo manipulation under anesthesia with intraarticular steroid injection 
7)Patients will be followed up as mentioned and "constant murley score" will be used to evaluate pain intensity and activities of daily living, movements and strength.
 
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