| 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
|
|
|
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
|
|
|
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
|
|
|
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. |