| CTRI Number |
CTRI/2023/12/060703 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [CRYOABLATION OF NERVE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study compares two treatment methods for improvement in pain and function in osteoarthritis of knee |
|
Scientific Title of Study
|
Effectiveness of fluoroscopy guided cryoablation of genicular nerves in comparison with steroid and local anaesthetic block in improving pain and function in patients with grade 3 and 4 osteoarthritis of knee: 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 |
Priyanka S U |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine And Rehabilitation Regional Institute of Medical Sciences
Imphal West
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7338040926 |
| Fax |
|
| Email |
priyankasu11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor and Head |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine And Rehabilitation
Regional Institute of Medical Sciences
Imphal West
Manipur
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 |
| Address |
Department of Physical Medicine And Rehabilitation
Regional Institute of Medical Sciences
Imphal West
Manipur
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
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka S U |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
Department of PMR, Room no:324,Kundolie PG girls HOSTEL,RIMS, Lamphelpat, Imphal West, Manipur
Imphal West
MANIPUR |
7338040926
priyankasu11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS (REGIONAL INSTITUTE OF MEDICAL SCIENCES) |
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: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluoroscopy guided cryoablation of genicular nerves |
Patient positioning and monitoring will be identical to the diagnostic nerve block procedure. After disinfection and sterile skin preparation, Skin and soft tissue were anaesthetised with 1 ml of 2% lignocaine at each of the 3 anatomic sites of genicular nerves for cryoablation. The patient will be positioned supine with the ipsilateral knee elevated using towels as this will help with lateral X-ray imaging. The procedure will be performed under a strict aseptic technique. A true anteroposterior (AP) image of the distal femur and proximal tibia will be obtained. Three target sites will be identified- superior lateral genicular nerve where the lateral femoral shaft meets the epicondyle, superior medial genicular nerve where the medial femoral shaft meets the epicondyle and inferior medial genicular nerve where the medial tibial shaft meets the epicondyle.
After locating the nerves, the cryoprobe will be inserted through the skin after cleaning and test freezing of the probe. Sensory stimulation with 50,100,150,200 Hz and motor stimulation with 1 and 2 Hz for 0.1 to 0.5 ms will be made. After confirming the site of the probe cryoprobe will be activated for 3 min as a freezing time, 30 sec as an unfreezing time for 1st cycle, and 3 min freezing time and 10 sec as an unfreezing in 2nd cycle. A total of 2 cycles at each site will be done. With a max low temperature of -78â°C (CO2) and -89â°C (N2O). The same procedure will be repeated at each target site (SL, SM, and IM genicular nerves).
They will be prohibited from making any alteration to their medication and therapy during follow-up.
( Intervention group-Fluoroscopy guided cryoablation of genicular nerves)
|
| Comparator Agent |
fluoroscopy guided steroid and local anaesthetic block of genicular nerves |
Genicular nerves consist of superomedial (SM), superolateral (SL), middle, inferolateral, inferomedial (IM) and recurrent tibial genicular nerve. However, targets only included the SL, SM, and IM geniculate nerves that pass through the periosteal region connecting the femoral shaft to the bilateral epicondyles and the shaft of the tibia to the medial epicondyle. Also, the Inferolateral genicular nerve will be avoided to prevent any injury to the common fibular nerve. The patient will be positioned supine with the ipsilateral knee elevated using towels as this helped with lateral X-ray imaging. The procedure will be performed under a strict aseptic technique. A true anteroposterior (AP) image of the distal femur and proximal tibia will be obtained. Three target sites will be identified- superior lateral genicular nerve where the lateral femoral shaft meets the epicondyle, superior medial genicular nerve where the medial femoral shaft meets the epicondyle and inferior medial genicular nerve where the medial tibial shaft meets the epicondyle.
After locating the nerves, 2 mL of a solution consisting of 1.5 mL of 0.5% bupivacaine and 0.5 mL (20 mg) of Triamcinolone Acetonide will be injected at each target. On the lateral image at each of the targets, a fine adjustment will be made to confirm the needle tip will be halfway across the thickness of the femur in the lateral fluoroscopic image. The same process will be repeated using a true AP image for the proximal tibia. The target for the inferior medial genicular, where the medial tibial shaft meets, the epicondyle will be identified using the technique mentioned above. The C- arm fluoroscopy will be adjusted to get a lateral image. The needle tip will be adjusted to be halfway across the tibial thickness.
(Comparator group- fluoroscopy guided steroid and local anaesthetic block of genicular nerves) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons with osteoarthritis of the knee as per 2016 revised ACR criteria for early diagnosis of osteoarthritis
2. Osteoarthritis of the knee with Kellgren Lawrence grade 3,4
3. Duration of symptoms more than 3 months
4. Age 40 to 70 years
5. VAS ≥ 4
6. Positive diagnostic block (>50% improvement in pain)
7. Willingness to participate in the study and comply with treatment and follow up
|
|
| ExclusionCriteria |
| Details |
1. Acute knee injury/pain
2. Prior knee surgery
3. Serious neurologic/psychiatric disorder/cognitive impairment
4. Intra articular injection with steroids/hyaluronan in the last 3 months
5. Recent myocardial infarction or stroke
6. Uncontrolled diabetes and hypertension/systemic diseases
7. Coagulation disorder
8. Local or systemic infections
9. Allergy to anaesthetic medication (Lignocaine and Bupivacaine) and steroids used
|
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Knee pain measured by VAS
|
At the end of 1st week, 4th week 12th week, and 24th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional outcome by WOMAC score. |
At the end of 1st week, 4th week 12th week, and 24th week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
31/12/2023 |
| 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
|
Knee osteoarthritis is a
progressive chronic degenerative musculoskeletal disease of the knee joint
which is the most commonest rheumatological condition causing pain, functional
impairment, chronic disability, and diminished quality of life. Diagnosis will
be made by the 2016 ACR criteria for early diagnosis of knee osteoarthritis.
Treatment should aim to relieve pain, improve function, limit disabilities, and
improve quality of life. Surgery is the definitive management of the later
stages of OA knee. So later stages of the disease and associated chronic pain
should be treated wisely with minimal side effects. Cryoablation of genicular nerves has recently
become popular in the management of chronic osteoarthritic knee pain due to its
potential of allowing for complete regeneration and functional recovery of
nerves with fewer adverse effects. The greatest limitation of cryoablation is
the lack of standardization. This study a single-blinded randomized controlled
trial shall be conducted in the Department of Physical Medicine and
Rehabilitation to determine the effectiveness of fluoroscopy-guided
cryoablation in comparison with local anaesthetic and steroid block of
genicular nerves in the treatment of patients with grade 3 and 4 osteoarthritis
of the knee. A sample size of 82 patients of grade 3 and 4 osteoarthritis of
knee attending PMR OPD, RIMS with knee pain will be chosen and randomized.
Outcomes will be measured using the VAS (Visual Analogue Scale) and WOMAC at
baseline, and post-intervention at 1st, 4th, 12th, and
24th weeks. For calculation, the Chi-square test, independent
t-test, and repeated measure ANOVA will be used and a p-value <0.05 will be
taken as significant.
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