| 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
|
|
|
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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |