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Clinical Trials/CTRI/2023/12/060703
CTRI/2023/12/060703Not yet recruitingPhase 2

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

Regional Institute of Medical Sciences1 site in 1 country82 target enrollmentStarted: December 31, 2023Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
82
Locations
1
Primary Endpoint
Knee pain measured by VAS

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Persons with osteoarthritis of the knee as per 2016 revised ACR criteria for early diagnosis of osteoarthritis
  • •Osteoarthritis of the knee with Kellgren Lawrence grade 3,4
  • •Duration of symptoms more than 3 months
  • •Age 40 to 70 years
  • •Positive diagnostic block (>50% improvement in pain)
  • •Willingness to participate in the study and comply with treatment and follow up.

Exclusion Criteria

  • •Acute knee injury/pain
  • •Prior knee surgery
  • •Serious neurologic/psychiatric disorder/cognitive impairment
  • •Intra articular injection with steroids/hyaluronan in the last 3 months
  • •Recent myocardial infarction or stroke
  • •Uncontrolled diabetes and hypertension/systemic diseases
  • •Coagulation disorder
  • •Local or systemic infections
  • •Allergy to anaesthetic medication (Lignocaine and Bupivacaine) and steroids used.

Outcomes

Primary Outcomes

Knee pain measured by VAS

Time Frame: At the end of 1st week, 4th week 12th week, and 24th week

Secondary Outcomes

  • Functional outcome by WOMAC score.(At the end of 1st week, 4th week 12th week, and 24th week)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Priyanka S U

Regional Institute of Medical Sciences

Study Sites (1)

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