| CTRI Number |
CTRI/2024/01/061714 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dry Needling in Achilles Tendinopathy in Basket ball players |
|
Scientific Title of Study
|
Efficacy Of Dry Needling In The Management Of Achilles Tendinopathy In Basketball Players |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITISH KUMAR SRIVASTAVA |
| Designation |
PG Student |
| Affiliation |
AMITY INSTITUTE OF HEALTH ALLIED SCIENCES |
| Address |
Room No.- LG 12, Basement, Department of Physiotherapy, Amity University
Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8417078478 |
| Fax |
|
| Email |
nitishsrivastava21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rabab Kaur |
| Designation |
Assistant Professor |
| Affiliation |
AMITY INSTITUTE OF HEALTH ALLIED SCIENCES |
| Address |
Staff room, 1st Floor, Department Of Physiotherapy, Amity University
Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
NITISH KUMAR SRIVASTAVA |
| Designation |
PG Student |
| Affiliation |
AMITY INSTITUTE OF HEALTH ALLIED SCIENCES |
| Address |
Room No.- LG 12, Basement, Department of Physiotherapy, Amity University
Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8417078478 |
| Fax |
|
| Email |
nitishsrivastava21@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPES Super Speciality Hospital Greater Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
NITISH KUMAR SRIVASTAVA |
| Address |
LG 12 Research Lab, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University SECTOR 125 Noida, Uttar Pradesh |
| Type of Sponsor |
Other [INSTITUTE ] |
|
|
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 Megha Gaur |
SPES Hospital |
Basement,
Department of physiotherapy,
Pari chowk NRI City omega 2 Noida Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9289374688
Meghagaur2909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL NTCC COMMITTEE AMITY INSTITUTE OF HEALTH ALLIED SCIENCES,AMITY UNIVERSITY UTTAR PRADESH |
Approved |
| SPES HOSPITAL |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S968||Injury of other specified musclesand tendons at ankle and foot level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRY NEEDLING |
Participants in the experimental group will undergo dry needling sessions targeting the Achilles tendon.Session will occur in 3 phases i.e Baseline 4th week and 8th Week. |
| Comparator Agent |
Sham Needling |
Participants will receive a placebo treatment and standard care.This session will also occur in three phases i.e baseline 4th week and 8th week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed Achilles Tendinopathy diagnosis of min 6 Week
2. Active competitive BasketBall Players.
3. Achilles Tendinopathy related functional
impairment.
4. No Achilles Tendinopathy intervention done in
past 3 months. |
|
| ExclusionCriteria |
| Details |
1. History of Tendon Rupture.
2. History of Medical Condition.
3. History of Dry Needling In Achilles
Tendinopathy.
4. Any Active Skin & Systemic Infection.
5. Any use of AntiCoagulants.
6. Physiological & Cognitive Disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VAS,
2. The Victorian Institute of
Sport Assessment - Achilles
(VISA-A) Questionnaire
3. GONIOMETER
4. FUNCTIONAL PERFORMANCE TEST |
1- Baseline
2- 4 weeks
3- 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PRESSURE ALGOMETER
|
4 WEEKS AND 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2024 |
| 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="2"
Days="0" |
|
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
|
This study holds substantial clinical significance as it addresses a critical gap in the current literature regarding the efficacy of dry needling in managing Achilles tendinopathy specifically within the basketball player population. By providing valuable insights into the potential benefits of this intervention, the findings from this research could contribute to optimizing the treatment approach for basketball players with Achilles tendinopathy, ultimately enhancing their pain management, functional recovery, and overall athletic performance.
AIM: This study aims to fill this gap by investigating the potential benefits of dry needling as a novel intervention for Achilles tendinopathy in basketball players. By examining its effects on pain reduction, functional improvement, tendon structure, and athletic performance, the research seeks to provide valuable insights into an effective and tailored treatment approach. |