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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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