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CTRI Number  CTRI/2024/04/065468 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Preventive
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Corticosteroid injection vs. Ultrasound therapy : Which works better for Achilles tendon pain? 
Scientific Title of Study   A comparative study of the efficacy of corticosteroid injection against ultrasound therapy in Achilles tendinopathy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHAMBHURAJ JAGADALE 
Designation  Post Graduate Trainee  
Affiliation  Sambhu Nath Pandit Hospital  
Address  Department of Physical Medicine and Rehabilitation,Sambhu Nath Pandit Hospital,11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  7757996130  
Fax    
Email  shambhuraj1@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JAYANTA SAHA 
Designation  MBBS, MD PMR 
Affiliation  Sambhu Nath Pandit Hospital 
Address  Department of Physical Medicine and Rehabilitation,Sambhu Nath Pandit Hospital,11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433094843  
Fax    
Email  djayantas@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  JAYANTA SAHA 
Designation  MBBS, MD PMR 
Affiliation  Sambhu Nath Pandit Hospital 
Address  Department of Physical Medicine and Rehabilitation, Sambhu Nath Pandit Hospital,11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433094843  
Fax    
Email  djayantas@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SHAMBHURAJ JAGADALE 
Address  Department of Physical Medicine and Rehabilitation, Sambhu Nath Pandit Hospital,11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020  
Type of Sponsor  Other [SELF] 
 
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 
JAYANTA SAHA  Sambhu Nath Pandit Hospita  Department of Physical Medicine and Rehabilitation, 11 Lala Lajpat Rai Sarani,Kolkata, West Bengal-700020
Kolkata
WEST BENGAL 
9433094843

djayantas@yahoo.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: M658||Other synovitis and tenosynovitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Corticosteroid injection   Patients will receive injection of 1ml 40mg/ml Triamcinolone acetonide into the peritendinous soft tissues , deliberately avoiding the tendon substance close to the insertion of achilles tendon . Followed by therapeutic stretching exercise and a shoe heel lift and analgesic as paracetamol 500mg sos.  
Comparator Agent  Ultrasound therapy   Patients will receive Therapeutic Ultrasound for 2 weeks followed by therapeutic stretching exercise and a shoe with heel lift and analgesic as paracetamol (500mg) sos. Therapeutic Ultrasound will be as follows: Duration – 6 days/week for 2 weeks for 3 min treatment sessions (area close to the insertion and proximal to insertion of achilles tendon) 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  Clinically confirmed cases of Achilles tendinopathy. 
 
ExclusionCriteria 
Details  1] Recent fracture in last 6 months
2] Infection of foot and ankle for last 6 months
3] Tumors of foot and ankle
4] Ankle and foot deformity
5] Charcot atrophy
6] Rheumatoid arthritis
7] Gout
8] Previous steroid injections or ultrasound therapy within past 6 months
9] Previous surgery on the Achilles tendon
10]Patients with neurological deficits (motor, sensory)
11] Uncontrolled Diabetes Mellitus
12] Uncontrolled Hypertension
13] Patients with bleeding disorders
14] Patients with implanted pacemaker
15] Patients with skin disease
16] Deformity due to advanced leprosy, buerger’s disease
17] Patients on anticoagulants
18] Pregnancy
19] Patients with Psychiatric disorders
20] Patients who are not willing or not in a sound mental state to give consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of corticosteroid injection against ultrasound therapy in Achilles tendinopathy.   At baseline,2 weeks, 4 weeks ,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare efficacy of corticosteroid injection against ultrasound therapy in Achilles tendinopathy.   At baseline,2 weeks, 4 weeks ,6 weeks 
 
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 4 
Date of First Enrollment (India)   19/04/2024 
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="0"
Months="8"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Achilles tendinopathy is one of the causes of heel pain , which is a common chief complaint found in day-to-day practice in outpatient clinics treated by health care professionals . Achilles tendinopathy is common in both sedentary and sports people , mostly due to chronic overuse . Achilles tendinopathy is a part of ankle injuries . Patients present with symptoms like tenderness , pain and with or without swelling .Further more exostoses can develop within tendon .Tendinopathy can be classified as insertional tendinopathy or non insertional tendinopathy. 
Diagnosis of Achilles tendinopathy can be done by clinical examination and by using self reported chief complaints of tendinopathy which includes location of pain , pain with tendon loading , tendon stiffness or pain over a specified time and overall rating using visual analogue scale . Other radiological examination like x-rays , ultrasonography and blood examination required to rule out differential diagnosis . 
Management of Achilles tendinopathy by non -surgical methods includes various physical therapies and modalities . Starting with conservative therapies for patients diagnosed with Achilles tendinopathy should include rest, heat, ice pack, stretching exercise, foot orthotics , topical medications and oral non-steroidal anti-inflammatory drugs (NSAIDs) . Further use of any other physical therapies , including ultrasound, extracorporeal shock waves, laser, and injections with steroids, autologous blood and platelet-rich plasma, prolotherapy , sclerosing agents and protease inhibitors .
Surgical treatments for Achilles tendinopathy include ventral paratenon stripping , open tendon debridement and tendon reconstruction procedures . The Foot and Ankle Ability measure (FAAM) can be used in assessment and monitoring of outcome measures achieved after management of Achilles tendinopathy .
There aren’t many research comparing the effectiveness of ultrasound therapy and corticosteroid injection. With conservative management (rest, heat, ice, stretching exercises, foot orthotics, topical medications, and oral non-steroidal anti-inflammatory drugs (NSAIDs)) common in both groups, the current study aims to compare the effectiveness of corticosteroid injection and ultra sound therapy. The study will be carried out after thoroughly educating the patients and using a predesigned study Performa that includes written consent, history taking, clinical examinations, investigations, and therapy information. All of the data will be examined at the conclusion of the study period in order to provide a detailed comparison analysis using the proper statistical methodology.
 
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