CTRI Number |
CTRI/2019/09/021308 [Registered on: 18/09/2019] Trial Registered Prospectively |
Last Modified On: |
19/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Radiofrequency nerve ablation] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To see the usefulness of attenuation of nerve causing heel pain by using instrument in the management of chronic heel pain |
Scientific Title of Study
|
Comparison of ultrasound guided pulsed radiofrequency ablation of medial calcaneal nerve and extracorporeal shock wave therapy in the management of recalcitrant plantar fasciitis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Moirangthem Janet |
Designation |
Post graduate trainee |
Affiliation |
Regional Institute of Medical Sciences |
Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat
Imphal West MANIPUR 795004 India |
Phone |
8014932808 |
Fax |
|
Email |
vivienne2811@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Longjam Nilachandra Singh |
Designation |
Associate Professor |
Affiliation |
Regional Institute of Medical Sciences |
Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat
Imphal West MANIPUR 795004 India |
Phone |
9436021309 |
Fax |
|
Email |
drnilalong@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Moirangthem Janet |
Designation |
Post graduate trainee |
Affiliation |
Regional Institute of Medical Sciences |
Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat
Imphal West MANIPUR 795004 India |
Phone |
8014932808 |
Fax |
|
Email |
vivienne2811@gmail.com |
|
Source of Monetary or Material Support
|
Department of Physical Medicine and Rehabilitation, RIMS,Imphal |
|
Primary Sponsor
|
Name |
Department of Physical Medicine and Rehabilitation |
Address |
Regional Institute of Medical Sciences, Imphal West, 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 Moirangthem Janet |
Regional Institute of Medical Sciences, Imphal |
Department of Physical Medicine and Rehabilitation, Injection room, Operation theatre Imphal West MANIPUR |
8014932808
vivienne2811@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
RESEARCH ETHICS BOARD RIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Extracorporeal shockwave therapy |
Extracorporeal shockwave therapy of the most tender point over the heel with frequency of 6Hz and pressure of 3bar. Session is performed once per week for a total of 3 sessios. Route is over the skin. |
Intervention |
Radiofrequency nerve ablation |
ultrasound guided radiofrequency nerve ablation of medial calcaneal nerve in recalcitrant plantar fasciitis. Ablation is applied intralesionally for 90secs at 90 degrees C for 2 cycles. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with plantar fasciitis for 6 months not responding to conservative management |
|
ExclusionCriteria |
Details |
Inflammatory arthritis,neurological defects of the foot,coagulopathy,infection,cancer,peripheral vascular, pregnancy, previous surgery on the plantar fascia or heel,previous local steroid injecctions within 3 monthsof the study, distorted anatomy |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Visual Analogue Scale, American Orthopedic Foot and Ankle Society (AOFAS) |
Baseline, 4th, 12th and 24th week |
|
Secondary Outcome
|
Outcome |
TimePoints |
Plantar fascia thickness measured by ultrasound |
Baseline, 4th, 12th and 24th week |
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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 3 |
Date of First Enrollment (India)
|
30/09/2019 |
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="1" Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Plantar fasciitis remains one of the leading causes of long term disability. Many studies have been conducted on management of pain and improvement in foot function. Therapy in the form of rest, stretching, analgesic agents, physical therapy, arch support, night splints, shoe modifications or steroid injections are the conservative treatments available. Extracorporeal shock wave therapy (ESWT), radiofrequency nerve ablation (RFNA) and platelet rich plasma (PRP) are other options that can be considered for recalcitrant plantar fasciitis. At present there are very limited literature regarding RFNA of medial calcaneal nerve for the treatment of recalcitrant plantar fasciitis. Therefore, the aim of the study is to determine the effectiveness of ultrasound guided radiofrequency nerve ablation in the management of plantar fasciitis. A sample size of 39 patients in each group who are willing to take part in the study will be taken from those plantar fasciitis patients who are attending the OPD of PMR department, RIMS. Outcomes will be measured by using , visual analogue scale ( VAS), ultrasound measurement of plantar fascia thickness and American Orthopedic Foot and Ankle Society (AOFAS) ankle hind-foot score at one, four, twelve and twenty-four weeks post- intervention. Study design will be randomized controlled trial. |