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CTRI Number  CTRI/2019/12/022237 [Registered on: 03/12/2019] Trial Registered Prospectively
Last Modified On: 10/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Low Vs High Dose Prednisolone In CRPS 
Scientific Title of Study   Comparison of efficacy and safety of Low (20 mg) vs High (40mg) dose oral Prednisolone in Complex Regional Pain Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  SGPGIMS Lucknow 
Address  Department of Neurology,SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  09450411673  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  SGPGIMS Lucknow 
Address  Department of Neurology,SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  09450411673  
Fax    
Email  jayanteek@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jayantee Kalita 
Designation  Professor 
Affiliation  SGPGIMS Lucknow 
Address  Department of Neurology,SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  09450411673  
Fax    
Email  jayanteek@yahoo.com  
 
Source of Monetary or Material Support  
Principal Investigator Prof Jayantee Kalita form Institutional research Fund 
 
Primary Sponsor  
Name  Prinicipal Investigator 
Address  Department of Neurology, SGPGIMS 
Type of Sponsor  Other [Principal Investigator] 
 
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 
Professor Jayantee Kalita  SGPGIMS LUCKNOW  Department of Neurology SGPGIMS LUCKNOW
Lucknow
UTTAR PRADESH 		 09450411673
05222668811
jayanteek@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, SGPGIMS Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G890||Central pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low (20 mg) vs High (40mg) dose oral Prednisolone in CRPS  The patients fulfilling the inclusion criteria will be randomized to prednisolone 40mg (group I) or 20mg (group II) using random number. Group I patients will receive 40mg for 2 weeks then taper to 10mg by 30 days. Group II will receive 20mg prednisolone daily for 2 weeks then will be tapered to 5mg by 30days.Both groups will be continued on 5 mg per day for next another months.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The patients with CRPS I of shoulder joint attending neurology service will be included. A diagnosis of CRPS-I will be based on the following features
1. Pain and tenderness during humeral abduction, flexion, and external rotation.
2. Pain and dorsal swelling over the carpal bones.
3. Moderate fusiform edema of metacarpo-phalangeal and inter-phalangeal joints.
4. Change in temperature, color, and dryness of skin.
5. Loss of dorsal skin lines and change in nails
 
 
ExclusionCriteria 
Details  Patients with uncontrolled hypertension, diabetes, infection, organ failure, malignancy, shoulder joint dislocation or infection, children (<18yrs), 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 
More than 50% improvements in VAS score  1 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in CRPS score, disability score and sleep quality by Daily sleep Interference Scale (DSIS)
Change in pro and anti-inflammatory cytokine levels
Side effects
 		 1 and 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/12/2019 
Date of Study Completion (India) 13/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Complex regional pain syndrome (CRPS) is characterized by pain in combination with sensory, autonomic, trophic, and motor changes (1,2). CRPS of shoulder joint occurs following stroke, trauma, dislocation and surgery. The incidence of CRPS-I following stroke has been reported in a few studies only. For the activities of daily living, a full range of painless movement, especially of the upper limb, is essential. Occurrence of CRPS-I may limit physiotherapy which results in increased spasticity and reduced muscle strength and contracture. Multiple pharmacological and non-pharmacological therapies for CRPS have been evaluated, mostly directed to fracture and other orthopedic conditions. The exact pathophysiology that links these triggers to the CRPS manifestation remains uncertain. Three major pathophysiological pathways are identified, including abnormal inflammatory and vasomotor response and aberrant neuronal plasticity. High levels of pro-inflammatory cytokines have been reported in patients with CRPS. There are autonomic dysfunctions in CRPS and oedema is due to pro inflammatory cytokines. This may be subsided by Corticostreroid therapy. Corticosteroids are the key drugs for immunological disorders, immune suppression, and immunomodulation. Studies in CRPS have shown remarkable improvement in reducing edema and pain following corticosteroid treatment (3-6). We have reported efficacy of prednisolone in CRPS I in which more than 80% patients improved (4). Majority of stroke patients have diabetes and hypertension rendering use of higher dose of prednisolone in them. If lower dose of prednisolone is effective in CRPS, these patients may be treated which likely to improve their pain thereby activity of daily activity.

Aim and Objectives

1. Comparison of efficacy and safety of 20 mg vs 40 mg prednisolone in complex regional pain syndrome (CRPS) in a double blind randomized clinical trial.

2. Effects of Prednisolone on cytokine level before and after the treatment between the two groups.

Subject and methods

Inclusion criteria: The patients with CRPS I of shoulder joint attending neurology service will be included. A diagnosis of CRPS-I will be based on the following features (4)

1. Pain and tenderness during humeral abduction, flexion, and external rotation.

2. Pain and dorsal swelling over the carpal bones.

3. Moderate fusiform edema of metacarpo-phalangeal and inter-phalangeal joints.

4. Change in temperature, color, and dryness of skin.

5. Loss of dorsal skin lines and change in nails

The severity of CRPS will be assessed on a 0 – 14 point scale, 0 being the lowest and 14 being the highest score (4). Patients with a CRPS score ≥ 8 will be included. Patient with VAS score more than 5 will be enrolled for treatment. Sleep disturbances also measured by on a 0-10 point scale , Daily sleep interference scale (DSIS), 0 being no interference in sleep and 10 being completely interfere with sleep.

Exclusion: Patients with uncontrolled hypertension, diabetes, infection, organ failure, malignancy, shoulder joint dislocation or infection, children (<18yrs), pregnancy and unwilling for consent will be excluded. 

Evaluation: Detailed medical and clinical examination will be done. The severity of CRPS will be done by CRPS score and pain by Visual Analogue Scale (VAS) score. Number of analgesic intake in the previous month, sleep disturbances and limitation of day to day work in a 0-100 scale will be evaluated. The hematology and serum chemistry will be noted. 5 ml venous blood will be collected before and after end of 1month for cytokine assay. Blood from 30 matched volunteers will also be collected. Cytokine will be measured by cytokine bead array assay. Kit will be bought by the PI using teaching allowance/research fund .

 Randomization and Treatment: The patients fulfilling the inclusion criteria will be randomized to prednisolone 40mg (group I) or 20mg (group II) using random number. Group I patients will receive 40mg for 2 weeks then taper to 10mg by 30 days. Group II will receive 20mg prednisolone daily for 2 weeks then will be tapered to 5mg by 30days.Both groups will be continued on 5 mg per day for next another months.

Outcome measures:

Primary outcome: More than 50% improvements in VAS score.

Secondary outcomes:

Improvement in CRPS score, disability score and sleep quality by Daily sleep Interference Scale (DSIS)

Change in pro and anti-inflammatory cytokine levels

Side effects

Statistical analysis:

The baseline parameters will be compared. Per protocol and intension to analysis will be done for primary outcome. For secondary outcome appropriate paramentric and nonparametric tests will be applied.

 


 
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