| CTRI Number |
CTRI/2024/02/063009 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of Prednisolone 20 mg vs Placebo in Diabetic patients with Frozen Shoulder |
|
Scientific Title of Study
|
Comparison of efficacy and safety of Prednisolone 20 mg vs Placebo in Diabetic patients with Complex Regional Pain Syndrome of upper extremity |
| Trial Acronym |
PPDCRPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2019-110-DM-109/PGI/BE/2024/Agenda 23/Date: 07Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9450411673 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor |
| Affiliation |
Department of Neurology |
| Address |
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9450411673 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9450411673 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences,Lucknow, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Professor Jayantee Kalita |
| Address |
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences,Lucknow, Uttar Pradesh, India |
| 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 |
| Professor Jayantee Kalita |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH |
9450411673
jayanteek@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G894||Chronic pain syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
The placebo group receive identical saccharine tablets for one month
Frequency- Once Daily
Total Duration- One month
Route- Oral |
| Intervention |
Prednisolone |
Prednisolone 20 mg for 2 weeks, then 15 mg for 5 days followed by 10 mg for 5 days followed by 5 mg for 5 days then stopped.
Frequency- Once Daily
Total Duration- 1 month
Route-Oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A) Continuous pain which is disproportionate to any inciting factor.
B) At least one symptom in three of the four following domains.
1) Sensory: hyperesthesia with or without allodynia.
2) Vasomotor: Asymmetry in temperature or skin color, skin color changes of the affected limb.
3) Sudomotor/edema: Presence of edema, sweating changes or sweating asymmetry.
4) Motor/ trophic: Reduced range of motion or motor dysfunction with or without trophic changes of the limb.
C). At least one sign in ≥ 2 of the following domains.
1) Sensory: Hyperalgesia (to pin prick) with or without allodynia (light touch, deep somatic presence or joint movements).
2) Vasomotor: Evidence of temperature or skin color asymmetry, or skin color changes.
3) Sudomotor/edema: edema, sweating changes or sweating asymmetry.
4) Motor or trophic: Evidence of deduced range of movement, motor dysfunction (weakness, dystonia or tremor) and or trophic changes in nail, skin or hair.
5) No other diagnosis could explain the symptoms or signs
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled hypertension, diabetes, infection, organ
failure, malignancy, shoulder joint dislocation or infection, pregnancy and unwilling for consent will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS score ≥ 50% |
One Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CRPS total score, and its different domains, HADS score, DISS score and side effects. |
One month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/02/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The Diabetes mellitus (DM) has 5 time more incidence of CRPS/Frozen shoulder leading to pain, restricted shoulder movement and hampering self-care. There are limited studies on the role of corticosteroids in frozen shoulder associated with DM patients. In our earlier studies post stroke CRPS oral prednisolone reduces pain and improved range of movements substantially compared to Piroxicam . We have also found prednisolone 40 mg and 20 mg equally effective in CRPS-I. In that study prednisolone 20 mg resulted in increased blood glucose in 24% which could be easily controlled with augmentation of drug, without withdrawal from the study. In this study we will include well controlled DM with HbA1C<8 %, without any ocular, cardiac and renal complication. The result of the proposed study likely to give an evidence whether prednisolone 20 mg is safe and effective in DM associated CRPS I. |