| CTRI Number |
CTRI/2019/05/018899 [Registered on: 02/05/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relief after pulsed radio-frequency treatment of saphenous nerve and adductor canal in knee pain of osteoarthritis
|
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Scientific Title of Study
|
Functional outcome and pain relief in primary osteoarthritis knee after radio-frequency treatment: a prospective randomised comparison between pulsed radio-frequency of saphenous nerve and adductor canal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok Jadon |
| Designation |
Chief Consultant & HOD Anaesthesia |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
06572316079 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok Jadon |
| Designation |
Chief Consultant & HOD Anaesthesia |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
06572316079 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Jadon |
| Designation |
Chief Consultant & HOD Anaesthesia |
| Affiliation |
Tata Motors Hospital, Jamshedpur |
| Address |
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Department of Anaesthesia, 1st floor, OT Complex, Tata Motors Hospital, Kharangajhar, Telco Colony, Jamshedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
06572316079 |
| Fax |
|
| Email |
jadona@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Motors Hospital, Jamshedpur |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Jadon |
| Address |
Tata Motors Hospital, Jamshedpur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Motors Hospital |
Kharangajhar, Telco Colony, Jamshedpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Jadon |
Tata Motors Hospital |
Department of Anaesthesia, First Floor, OT Complex, Tata Motors Hospital, Jamshedpur
Purbi Singhbhum
JHARKHAND |
06572316079
jadona@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee tata Motors Hospital, Jamshedpur |
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: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulsed Radio Therapy (PRF) treatment of Adductor Canal |
Patients of chronic knee pain due to osteoarthritis will be selected randomly and PRF of adductor canal will be done. An observer blinded about procedure will observe the pain relief from 10th day to 6 months. Patients will be given analgesics and physiotherapy. If pain relief is not satisfactory after 6months an alternate intervention will be advised. |
| Intervention |
Pulsed Radio Therapy (PRF) treatment of Saphenous nerve |
Patients of chronic knee pain due to osteoarthritis will be selected randomly and PRF of saphenous nerve will be done. An observer blinded about procedure will observe the pain relief from 10th day to 6 months. Patients will be given analgesics and physiotherapy. If pain relief is not satisfactory after 6months an alternate intervention will be advised. |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering with chronic pain of one or both knees due to osteoarthritis of knee for more then3 months and inadequate pain relief with conservative treatment. Radiological evidence of grade II-IV. |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to local anaesthetics.
2. Contraindication to radio frequency treatment.
3. Contraindication to regional anaesthesia |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Relief
Improvement in functional scores |
10th day, 1 month, 3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirements of analgesic drugs
Complication of procedure
Patients satisfaction |
10th day, 1 month, 3 month, 6 month |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/05/2019 |
| 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="0"
Days="0" |
|
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)?
|
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Brief Summary
|
Knee osteoarthritis (OA) is the most common cause of knee pain and disability. Many non-invasive treatments to treat OA knee pain are available however, they provide only short-term relief. Radio frequency ablation (RFA)of genicular nerves and pulsed radio frequency(PRF) of saphenous nerve (SN) have shown long lasting relief. The adductor canal (AC), which contains saphenous nerve along with other sensory nerves, which supply knee, has been effectively used for postoperative analgesia after total knee arthroplasty (TKA). We have a hypothesis that, PRF of adductor canal (PRF-AC) will provide effective and sustained pain relief in OA knee pain. As there is no comparative study, we wish to conduct a randomised, double blinded comparative study of PRF of saphenous nerve (PRF-SN) and PRF-AC for OA knee pain. Two group of 25 patients in each group will be given either PRF-SN or PRF-AC and will be compared for analgesic efficacy and duration of pain relief. Western Ontario and Mc master Universities Osteoarthritis Index (WOMAC), OXFORD knee score and Visual analogue score (VAS) will be used for assessment of functional outcome along with pain relief. Any complication of procedure, patient satisfaction and change in the medicine use will also be compared. If PRF-AC found to be effective to provide long-term relief, will open a new avenue of management in OA knee pain.
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