FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/10/021733 [Registered on: 21/10/2019] Trial Registered Prospectively
Last Modified On: 21/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Pulsed Radiofrequency Ablation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of shoulder pain in patients of paralysis due to stroke under ultrasound guidance by bupivacaine and radiofrequency ablation 
Scientific Title of Study   COMPARISON OF ULTRASOUND GUIDED PULSED RADIOFREQUENCY ABLATION AND BUPIVACAINE BLOCK OF SUPRASCAPULAR NERVE IN REDUCTION OF PAIN AND DISABILITY IN HEMIPLEGIC SHOULDER PAIN: A RANDOMIZED CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chandrakant Pilania 
Designation  Postgraduate Trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  PGT room, PMR ward, Department of Physical Medicine and Rehabilitation, RIMS, Imphal Manipur
Room no- 5, PG Gents Hostel no- 2, RIMS campus, Imphal Manipur 795004
Imphal West
MANIPUR
795004
India 
Phone  8209178449  
Fax    
Email  dr.ckp88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nilachandra Singh 
Designation  Associate professor 
Affiliation  Regional Institute of Medical Sciences 
Address  OPD block, Department of Physical Medicine and Rehabilitation, RIMS, Imphal Manipur
OPD block, Department of Physical Medicine and Rehabilitation, RIMS, Imphal Manipur 795004
Imphal West
MANIPUR
795004
India 
Phone  8209178449  
Fax    
Email  drnilalong@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chandrakant Pilania 
Designation  Postgraduate Trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  PGT room, PMR ward, Department of PMR, RIMS, Imphal Manipur
PGT room, PMR ward, Department of PMR, RIMS, Imphal Manipur 795004
Imphal West
MANIPUR
795004
India 
Phone  8209178449  
Fax    
Email  dr.ckp88@gmail.com  
 
Source of Monetary or Material Support  
RIMS Imphal 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences Imphal 
Address  Department of PMR, RIMS Imphal Manipur 
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 Chandrakant Pilania  Regional Institute of Medical Sciences  PGT room, PMR waed, Department of PMR, RIMS Imphal, Manipur 795004
Imphal West
MANIPUR 
8209178449

dr.ckp88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided bupivacaine block of suprascapular nerve  The patient in sitting position, skin cleaning with 10% betadine and spirit solution. Suprascapular notch will be identified. A 21-gauge needle will be inserted along the longitudinal axis of the ultrasound beam. This needle is chosen due to its good ultrasound visibility. The needle is visualized in its full course. The endpoint for injection will be a ultrasound image demonstrating the needle tip in proximity to the suprascapular nerve in the suprascapular notch. 10 ml of 0.5% bupivacaine will be injected. The injection and spread of local anesthetic will be visualized. 
Intervention  ultrasound guided pulsed radiofrequency ablation of suprascapular nerve  The patient in sitting position, skin cleaning with 10% betadine and spirit solution. Suprascapular notch will be identified. A 100 mm long radiofrequency needle with 10 mm active tip will be advanced under ultrasound guidance toward the scapular notch. RF probe was inserted and checked for stimulation. Three cycles of 120 seconds pulsed mode RF lesioning was performed keeping the temperature constant at 42ËšC, at a frequency of 2Hz and pulse width of 20 milliseconds.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed as acute stroke within the previous 12 months with hemiplegic shoulder pain.
Pain severity with minimum score of 5 based on 10 scale VAS.
Willingness to comply with treatment and follow-up assessments.
 
 
ExclusionCriteria 
Details  1. Cognitive deficit that precluded patients from reliably using subjective outcome measures scales [Mini Mental State Examination]
2. Allergy to proposed injection agents (lidocaine and Bupivacaine)
3. Degenerative changes at the glenohumeral joint as shown by a standard anteroposterior radiograph
4. Any recent febrile or infectious disease (systemic & local)
5. History of any malignancy (including hematologic and non-hematologic malignancies)
6. Previous history of systemic inflammatory joint disease like rheumatoid arthritis, gout, etc
7. Metabolic or systemic disease like ischemic heart disease, hepatitis, uncontrolled diabetes mellitus
8. Any trauma, fracture, bony malformation or dislocation of shoulder
9. History of autoimmune and hematological disorders
10. Intra or periarticular steroid injection to shoulder in previous 2 months
11. Platelet counts of less than 150,000 per micro liter
12. Cardiac arrhythmia or a pacemaker
13. Hemorrhagic stroke
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual Analog Scale (VAS)
2. Shoulder Range Of Motion (ROM)
 
At 1st, 4th, 12th and 24th week
 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Pain And Disability Index (SPADI)   1, 4, 12 and 24 weeks 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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 1 
Date of First Enrollment (India)   21/10/2019 
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="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The occurrence of shoulder pain after stroke is quite common in hemiplegia. Shoulder pain can negatively affect rehabilitation outcomes. It may not only interfere with shoulder function, but also interfere with balance, walking, transfers and performance of self-care activities. Many treatment options are available depending on cause of HSP like analgesics, anticonvulsants like (gabapentin or carbamazepine), oral corticosteroids, steroid injection (intra-articular or subacromial or biceps tendon sheath ), stellate ganglion block, manipulation, non-pharmacological modalities like positioning of affected limb, passive range of motion exercises, sling when upright, transcutaneous nerve stimulation, ultrasound, functional electric stimulation.

               Pulsed radiofrequency ablation of suprascapular nerve and suprascapular nerve block both have been proved to produce good results in primary care as suprascapular nerve supplies 70 percent sensory supply of the shoulder joint, but there is no comparative study between ultrasound guided radiofrequency ablation of suprascapular nerve and suprascapular nerve block available in literature at present. Therefore a randomized controlled study will be done in the Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences; Imphal to compare the effectiveness between ultrasound guided radiofrequency ablation of suprascapular nerve and suprascapular nerve block in reduction of pain and functional disability in HSP. The outcome variables will be measured before starting intervention (baseline) and at 1, 4, 12 and 24 weeks post-intervention follow up. Data will be analyzed by using SPSS Version 21. To represent descriptive statistics, mean and standard deviation will be used, for analytical statistics independent t test will be used and p-value < 0.05 will be taken as significant.

 
Close