| CTRI Number |
CTRI/2024/01/062152 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [CRYOABLATION OF SUPRASCAPULAR NERVE ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study compares two treatment methods for enhancing function and decreasing pain in adhesive capsulitis of shoulder |
|
Scientific Title of Study
|
EFFECTIVENESS OF ULTRASOUND GUIDED CRYOABLATION OF SUPRASCAPULAR NERVE IN COMPARISON WITH STEROID AND LOCAL ANAESTHETIC BLOCK FOLLOWED BY MANIPULATION FOR REDUCTION OF PAIN AND FUNCTIONAL DISABILITY IN PATIENT WITH ADHESIVE CAPSULITIS OF THE SHOULDER: A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mongjam Anganba Khumancha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
Manipur
795004
India
Imphal West
MANIPUR
795004
India |
| Phone |
7005171825 |
| Fax |
|
| Email |
anganbakhumancha2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor and Head |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
Manipur
795004
India
Imphal West
MANIPUR
795004
India |
| Phone |
7005018045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor and Head |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur
Imphal West
Manipur
795004
India
Imphal West
MANIPUR
795004
India |
| Phone |
7005018045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Regional Institute of Medical Sciences, Lamphelpat, Imphal West, Manipur, 795004 |
| 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 |
| MONGJAM ANGANBA KHUMANCHA |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF PMR, RIMS, LAMPHELPAT,IMPHAL WEST, MANIPUR
Imphal West
MANIPUR |
7005171825
anganbakhumancha2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| REASERCH ETHICS BOARD RIMS ( REGIONAL INSTITUTE OF MEDICA SCIENCES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided cryoablation of suprascapular nerves |
Cryoablation of the Suprascapular Nerve
The patient will be kept sitting position with the affected shoulder in full adduction and relaxed. Then ultrasound machine will be positioned on the right side in front of the patient and the injection site will be approached from behind the patient.
The skin will be cleaned with 10% povidone-iodine and spirit solution. A thin layer of sterile gel will be placed between the draped ultrasound transducer and the skin. The linear transducer will be placed vertically over the fossa, first locating the scapula. After locating the supraspinatus muscle in the fossa, the probe images the floor of the supraspinatus fossa along its long axis.
The point at which the suprascapular bone becomes discontinuous due to the suprascapular notch will be identified. Bridging the notch in its base is the superior transverse scapular ligament. The suprascapular nerve will be found under the superior transverse scapular ligament. Overlying the ligament is the suprascapular artery, which will be avoided during the needle insertion. Covering the notch is the supraspinatus and the trapezius muscle. The needle will be advanced in the plane into its final position in the notch. The skin and soft tissues in the region of cryoablation will be infiltrated with 2 ml of 2% lidocaine without epinephrine. After locating the nerves under ultrasound guidance, a cryoprobe is inserted through the skin after cleaning and test freezing of the probe. With the help of in-built diagnostic nerve stimulation sensory with 50,100,150,200 Hz and motor with 1 and 2 Hz for 0.1 to 0.5 ms will be made. After confirming the site, the cryoprobe will be activated for 3 min as a freezing time 30 sec as an unfreezing time and 3 min freezing and 10 seconds unfreezing for 2 cycles with a maximum low temperature of -78â°C (CO2). Then, the shoulder will be manipulated using a short arm lever and a fixed scapula in supine a position with the sequence of flexion, extension, abduction and adduction, and external and internal rotation of the shoulder joint.
Participants will be discharged if there are no significant complications, such as pain, bleeding, or pneumothorax.
|
| Comparator Agent |
Ultrasound guided steroid and local anaesthetic block of suprascapular nerve |
As described above suprascapular fossa will be identified by using ultrasound and then, the suprascapular nerve and suprascapular artery will be identified as a pulsatile structure in the region of the suprascapular notch. A 22-G spinal needle will be inserted along the longitudinal axis of the ultrasound beam. The needle will be visualized in its full course. The point for injection will be an ultrasound image demonstrating the needle tip in proximity to the suprascapular nerve in the suprascapular notch. Bupivacaine 0.5% (10 ml) and 40mg triamcinolone acetonide will be injected. The injection and spread of local anaesthetic will be visualized. The shoulder will be manipulated using a short arm lever and a fixed scapula in supine a position with the sequence of flexion, extension, abduction and adduction, and external and internal rotation of the shoulder joint. All the participants will receive exercise therapy after the completion of the intervention. A rescue drug of 500 mg of paracetamol will be given as and when required. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 40-60 years
2. Diagnosed case of stage II and stage III adhesive capsulitis based on clinical staging
3. Patients who are willing to comply with the study and follow-up assessments
|
|
| ExclusionCriteria |
| Details |
1. Any recent febrile or infectious disease
2. Patients with osteoporosis
3. Patients with a history of fracture around shoulder joint or dislocations of shoulder joint
4. Malignancy
5. Autoimmune and haematological disorders
6. Impaired cognition
7. Pregnancy
|
|
|
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 |
Shoulder pain and disability measured by SPADI and VAS
|
At the end of 1st week, 4th week, 12th week and 24th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional outcome measured by ROM of shoulder |
At the end of 1st week, 4th week, 12th week and 24th week
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2 |
|
Date of First Enrollment (India)
|
03/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Adhesive capsulitis is an idiopathic, painful, regular restriction of
all shoulder movements with normal radiographs and is self-limiting in nature, affecting activities of daily
living (ADL) and reducing the quality of life. Treatment should aim to relieve
pain, improve function, limit disabilities and improve quality of life but the
best treatment is still subject to debate. Due to the recent emergence of the
effectiveness of cryoablation of nerves in the treatment of various painful
musculoskeletal conditions and the background of inconclusive evidence for
treatment modalities for AC, and due to the limited number of studies available
for cryoablation in the management of adhesive capsulitis, there is a need to
examine the role of cryoablation of suprascapular nerve in adhesive capsulitis.
Thus a randomized controlled trial shall be conducted in the Department of
Physical Medicine and Rehabilitation, RIMS, Imphal to compare
the effectiveness of ultrasound-guided cryoablation of suprascapular nerve with
steroid and local anaesthetic for reduction of pain and functional disabilities
in patients with adhesive capsulitis of the shoulder. The outcome variables will be
measured at baseline and 1, 4, 12 and 24 weeks post-intervention follow-up. For
calculation, the Chi-square test, independent t-test, and repeated measure
ANOVA will be used and a p-value <0.05 will be considered statistically
significant.
|