| CTRI Number |
CTRI/2023/01/048829 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of training paced by external sound with oxygen therapy in athletes with knee pain |
|
Scientific Title of Study
|
Effectiveness of Tendon Neuroplastic Training and Oxygen Therapy in athletes with patellar tendinopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Bijalwan |
| Designation |
Physiotherapist |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
7017628965 |
| Fax |
|
| Email |
kunalbijalwan52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Head of department |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
9988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Head of department |
| Affiliation |
Amity Institute of Physiotherapy |
| Address |
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
Amity Institute of Physiotherapy Amity University, Sector-125, Noida,
Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201303
India
UTTAR PRADESH
201303
India |
| Phone |
9988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Physiotherapy, Amity University Sector-125 Noida Uttar Pradesh. Gautam Buddha Nagar UTTAR PRADESH 201303 India |
|
|
Primary Sponsor
|
| Name |
Kunal Bijalwan |
| Address |
Amity Institute of Physiotherapy, Amity University Sector-125 Noida
Uttar Pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| 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 |
| Dr Jasobanta Sethi |
Amity Institute of Physiotherapy |
F1, LGF, LG 101 , Sector 125 Amity University NOIDA Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9988600462
jsethi@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oxygen Therapy in patellar tendinopathy |
Athletes in this group C will only receive oxygen therapy, subjects will be given oxygen via an oxygen concentrator at 3 LPM through nasal prongs. The subjects will be comfortably positioned in supine lying and the oxygen will be given at 3 LPM for 15 minutes, this intervention will be given 3 times a week. |
| Comparator Agent |
Standard Rehabilitation protocol for patellar tendinopathy |
This Group B is our controlled group in which all the athletes with the condition will go through the standard rehabilitation protocol for patellar tendinopathy consisting of a pain reduction phase through modalities (TENS, US, CRYOTHERAPY) followed by isometric exercises, strengthening exercises, and slow heavy eccentric loading exercises for the tendon which is shown to have good results in tendinopathy in the literature. |
| Comparator Agent |
Tendon neuroplastic training in patellar tendinopathy |
Athletes in this group D will receive the tendon neuroplastic training with conventional rehabilitation protocol exercises consisting of isometric and isotonic for stage 1(isometric) and stage 2(isotonic) rehabilitation. For the tendon neuroplastic training, we will use metronome – reloaded application for the external auditory que to provide structure to the timing of the contraction.The exercises will be performed 3 times a week,the exercises in this group will be the same as perfromed in the group a which combines both the endon neuroplastic training and oxygen therapy. |
| Intervention |
Tendon neuroplastic training with oxygen therapy |
Athletes in this group A will receive tendon neuroplastic training with oxygen therapy. Subjects selected for this group will be given oxygen at 3 LPM via an oxygen concentrator. The subjects will be positioned in supine lying and the oxygen will be given by nasal prongs for a period of fifteen minutes after that they will have to perform exercises on the tendon neuroplastic training principle for it we will be using metronome reloaded application for the auditory cue by which the athlete will pace his contraction. All the exercises will be performed 3 times a week, exercises are as follows 1. Knee extension holds 2. leg press holds 3. wall squat holds, these 3 exercises will be performed only when the athletes have pain while performing exercises, the intensity of these exercises will be 45 seconds of hold and 10 seconds of relaxation.
4. squats 5. knee extensions 6. leg press, these exercises will be performed when there is no pain and the intensity will be 4 sets of 10-15 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Athletes, Anterior Knee pain, Patellar tendinopathy, Age group 15-35 years, inferior pole of patella tenderness, Positive single leg declined squat test |
|
| ExclusionCriteria |
| Details |
Any Musculoskeletal pathology affecting their lower leg in the last six months, History of knee surgery, on medication, any respiratory condition, already enrolled in a physiotherapy rehabilitation program
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Victorian Institute of sports medicine (VISA-P)
Tenderness– Algometer
Pain–Numeric Pain Rating Scale (NPRS)
|
All the above parameter will be taken at baseline 0 weeks, the next recording will be at the end of 2 week and last recording will be at the end 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life– WHOQOL-100 |
This parameter will be taken at baseline 0 weeks, then at the end of 2 weeks and the last recording will be taken at the end of 4 week |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patellar Tendinopathy is one of the major lower limb tendinopathies affecting athletes, major factors that affect the athlete in patellar tendinopathy are pain, tenderness, reduced ability to transfer loads, and overall poor performance on and off the field. Recent studies on tendon neuroplastic training and oxygen therapy show a positive effect on the condition, but there is very less data that combines these two different entities in patellar tendinopathy.
The objectives of this study are to:-
1. To test the efficacy of tendon neuroplastic training and oxygen therapy combined on pain levels in athletes with patellar tendinopathy.
2. To test the efficacy of tendon neuroplastic training and oxygen therapy combined on tenderness levels in athletes with patellar tendinopathy.
3. To test the efficacy of tendon neuroplastic training and oxygen therapy combined on the quality of life of an athlete
4. To test the efficacy of these interventions alone in athletes with patellar tendinopathy.
5. To compare the effectiveness of tendon neuroplastic training combined with oxygen therapy with a controlled group consisting of standard rehabilitation for patellar tendinopathy. |