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CTRI Number  CTRI/2023/03/050197 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 22/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Reducing pain & disability in plantar fasciitis with pes planus by conservative methods. 
Scientific Title of Study   A comparative study of reducing pain and improvement of foot function related disability in chronic plantar fasciitis with mild to moderate pes planus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnendu Roy 
Designation  Pgt 
Affiliation  Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH 
Address  Room No: 7, PMR OPD, Department of Physical Medicine & Rehabilitation, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH, 11, lala lajpat rai sarani, kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433377303  
Fax    
Email  krishnendu.mbbs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayanta Saha 
Designation  Guide (Sr Consultant) 
Affiliation  Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH. 
Address  Room no:7, PMR OPD, Dept of Physical Medicine & Rehabilitation, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH. 11, lala lajpat rai sarani, kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433094843  
Fax    
Email  djayantas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnendu Roy 
Designation  Pgt 
Affiliation  Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH 
Address  Room No: 7, PMR OPD, Department of Physical Medicine & Rehabilitation, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH, 11, lala lajpat rai sarani, kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433377303  
Fax    
Email  krishnendu.mbbs@gmail.com  
 
Source of Monetary or Material Support  
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH, 11, lala lajpat rai sarani, kolkata-700020 
 
Primary Sponsor  
Name  SAMBHUNATH PANDIT HOSPITAL 
Address  11, LALA LAJPAT RAI SARANI, KOLKATA-700020 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR KRISHNENDU ROY  2/O, HO CHI MINH SARANI, SANJIVPALLY, BEHALA, KOLKATA-700034 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnendu Roy  Room No:7, PMR OPD, Dept of PMR, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH,  Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH, 11, lala lajpat rai sarani, kolkata-700020
Kolkata
WEST BENGAL 
9433377303

krishnendu.mbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER RESEARCH OVERSIGHT COMMITTEE  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 
Intervention  INJECTION OF TRIAMCINOLONE ACETONIDE   GROUP-A - Patients will receive Injection of 2ml of a suspension containing 20mg Triamcinolone acetonide(0.5 ml) and 2% solution of lignocaine (1.5 ml) without adrenaline, near the origin of plantar fascia followed by therapeutic stretching exercise and a shoe with raise medial arch and analgesic as paracetamol 500mg sos. Dose: 20mg Frequency: single dose Route of administration: intra articular Total duration: single dose  
Comparator Agent  ULTRA SOUND THERAPY  GROUP-B – Patients will receive Therapeutic Ultrasound for 2 weeks followed by therapeutic starching exercise and a shoe with raise medial arch and analgesic as paracetamol (500mg) sos. Therapeutic Ultrasound will be as follows: Duration – 6days/week x 2Weeks, 3 minutes on each region (cacaneal medial tuberosity and on the 2cm distal to tuberosity) each session. Intensity- 2 watt/cm2 Frequency- 1 MHZ Mode- continuous mode  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Clinically confirmed cases of chronic plantar fasciitis (duration more than 3 months)
2) Pes planus (mild to moderate) confirmed by AP & weight bearing lateral X-Ray of foot and ankle.
 
 
ExclusionCriteria 
Details  1] Patients who are not willing or not in a sound mental state to give consent
2] Infection of foot and ankle for last 6 months
3] Tumours of foot and ankle
4] Recent fracture in last 6 months
5] Uncontrolled Diabetes Mellitus
6] Uncontrolled Hypertension
7] Patients with neurological deficits (motor, sensory)
8] Charcot atrophy
9] Foot deformity other than pesplanus
10] Patients with bleeding disorders
11] Patients with Psychiatric disorders
12] Patients with implanted pacemaker
13] Patients with skin disease
14] Deformity due to advanced leprosy, buerger’s disease
15] Known hypersensitivity to lignocaine
16] Rheumatoid arthritis
17] Gout
18] Pregnancy
19] Patients on anticoagulants
20] Previous steroid injections within past 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To assess any improvement in VAS score after corticosteroid injection
2)To assess any improvement in VAS score after UST
 
1) 0 WEEK
2) 4 WEEK
3) 8 WEEK
4) 12 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess any improvement in FFI score.
2)To compare improvement in both the groups on the basis of those above parameters.
 
1) 0 WEEK
2) 4 WEEK
3) 8 WEEK
4) 12 WEEK 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/03/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

SUMMARY OF THE PROPOSAL

Plantar fasciitis, one of the most common causes of heel pain, presents a challenge and treated by health care professionals. It affects both sedentary and athletic people and is thought to result from chronic overload and biomechanical abnormalities either from lifestyle or exercise which results in pain and inflammation of plantar fascia.

The exact cause remains poorly understood. Limited data from case-control studies reveal possible contributing factors of obesity, occupations with prolonged standing, pes planus, pes cavus (high arches) reduced ankle dorsiflexion less than 10°, and inferior calcaneal exostoses (heel spurs). There is a high incidence in runners, and there could be contributions from repetitive micro trauma, faulty running shoes or the running surface, but evidence is limited.

In the case of flatfoot, the subtalar joint remains pronated after foot is flat before mid-stance and midtarsal joint is not locked. (5) When abnormal weight-bearing condition persists and the talocalcaneus joint gets chronically subluxed, the foot cannot support the rigid propulsion for the normal gait cycle. After heel strike during the first half of the stance phase of the gait cycle, the tibia turns inward and the foot excessively pronates to allow flattening of the foot. This mechanism stretches the plantar fascia. As the foot progresses from foot-flat to push-off, the toes dorsiflex and the plantar fascia tightens. As the plantar fascia extends distal to the metatarsal head, tension causes the head to depress and the arch to rise. The plantar fascia pulls on its medial tubercle origin with more effort to create calcaneus inversion in a flatfoot subject with heel valgus. Therefore, the repetitive traction placed on the plantar fascia during walking or running may lead to microtears and inflammatory response.

Historically a broad range of conservative therapies have been used to treat plantar fasciitis. Non-surgical treatment includes rest, heat, ice pack, stretching exercise, foot orthotics, night splinting, taping, topical medications, oral non-steroidal anti-inflammatory drugs (NSAIDs), extracorporeal shock waves, laser, and percutaneous injection with steroids, autologous blood and platelet-rich plasma. Surgical options include release of plantar fascia, ultrasound-guided fasciotomy and co-ablation surgery. Several studies compared various treatment modalities with various degrees of success rate, but there is no clear-cut treatment protocol. For the majority of patients, plantar fasciitis is a self-limiting condition and can be treated effectively by nonsurgical treatments.

Present study is intended for evaluating the comparative efficacy of corticosteroid injection against ultra sound therapy with stretching exercise, shoe modification with medial arch support, analgesics in SOS are common in all groups. Not many studies have been done to compare these two standard methods in treatment of Plantar Fasciitis with pes planus (mild to moderate). After taking informed written consent, the information about history taking, detailed clinical examination and investigations will be included in a predesigned study Performa. The obtained data will be analysed using appropriate statistical technique 
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