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CTRI Number  CTRI/2023/04/051567 [Registered on: 12/04/2023] Trial Registered Prospectively
Last Modified On: 10/04/2023
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   A study to analyse the effect of plyometric exercise training among patients with lateral elbow pain  
Scientific Title of Study   A study to analyse the effect of plyometric exercise training among patients with lateral elbow pain  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  J Niveditha 
Designation  post graduate 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute Of Higher Education And Research, Porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  8610018369  
Fax    
Email  nivedithajayaraman2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Angeline 
Designation  Assistant professor 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute Of Higher Education And Research, Faculty Of Physiotherapy, Porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Angeline 
Designation  Assistant professor 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Sri Ramachandra Institute Of Higher Education And Research, Faculty Of Physiotherapy, Porur

Kancheepuram
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin75@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute Of Higher Education And Research 
 
Primary Sponsor  
Name  J.Niveditha 
Address  Sri ramachandra institute of higher education and research, faculty of physiotherapy, porur, chennai-600116 
Type of Sponsor  Other [Post Graduate Thesis] 
 
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 
J Niveditha  Sri Ramachandra hospital - New block OPD - Faculty of physiotherapy.  Sri ramachandra institute of higher education and research, faculty of physiotherapy, new block out patient department, porur, chennai-600116
Chennai
TAMIL NADU 		 8610018369
0
nivedithajayaraman2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M771||Lateral epicondylitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound therapy and plyometric exercises   Ultrasound therapy: Site- tenoperiosteal junction of extensor carpi radialis brevis, At 1.4 pulse ratio, Frequency: 1MHZ, Intensity:105 W/cm2, Duration: 5minutes plyometric exercises program : Medicine ball exercises, flexbar exercises, resistance tube exercises & Ultrasound therapy -Flex Bar Exercise Program: flex bar exercise was given for 6 weeks 5 times a week. The Flex Bar exercise was carried out for three sets of fifteen repetitions. Every recurrence took 4 seconds to complete the exercise, and there was a 30-second rest among each set of recurrences of the exercise. This exercise program was carried out in a seated or standing position. -Resistance tube exercise: It includes biceps curls and triceps extension 1)Biceps curls: Stand with feet hip-width apart and band securely under your feet. Hold the handles in front of your waist or thighs with your palms facing you. Curl both biceps, pausing at the top. Release arms and return to starting position. 2)Triceps extension: Stand with your feet staggered and resistance band securely under your back foot. Hold the band over your back with both arms bent at the elbow and parallel to the ground. Keeping back flat and core engaged, extend right arm up overhead, palm facing away from body. then lower back down. -Medicine ball exercises: 1)Bilateral Chest Press and Throw: Standing While standing and with feet placed in a stride position for balance, have the patient catch a weighted ball with both hands, bringing it to the chest (eccentric phase), and then throw it back to the therapist or onto a rebounder (concentric phase) 2)Bilateral Overhead Catch and Throw : While standing and with feet placed in a stride position for balance, have the patient use both hands to catch a weighted ball thrown over the head, controlling the momentum of the ball with shoulder and elbow musculature (eccentric phase), and then throw the ball back quickly to the therapist or onto a rebounder(concentric phase). 3)Throw and Catch with Elbow Action : While in a standing position and with the arm positioned along the side of the trunk, have the patient throw a weighted ball into the air with one hand, using primarily elbow flexion; catch it, allowing the elbow to extend with control (eccentric phase); and then quickly throw it into the air again (concentric phase). 4)Unilateral Throw and Catch with Wrist Action : While seated, have the patient stabilize the elbow on the thigh in about 90° flexion, and with the forearm supinated, toss a weighted ball or bean bag into the air using primarily wrist flexion; catch it, allowing the wrist to extend under control (eccentric phases); and then quickly toss it into the air again (concentric phase). 5)Simulated Sport Activities: Dribble a weighted ball or basketball against a wall or on the floor using either elbow or wrist actions. 
Comparator Agent  Ultrasound therapy and strengthening and stretching exercises   Ultrasound therapy: Site- tenoperiosteal junction of extensor carpi radialis brevis, At 1.4 pulse ratio, Frequency: 1MHZ, Intensity:105 W/cm2, Duration: 5minutes Strengthening exercises: procedure-isometric contractions with the elbow in flexion to 90 degree, with the hand of unaffected arm applying manual resistance over the dorsum of the supinated arm of the affected side. pain free isometric contractions of the wrist extensors will be initiated and held for 5 to 10 seconds. dosage: 15 contractions per session, thrice per week for 6 weeks. progression- includes forearm pronation as the starting position and increasing resistance Stretching exercises: procedure- forearm pronation, elbow extension, the wrist being palmar- flexed using the other hand of the patient or with the help of the wall. this will be held for few seconds and then released. dosage: 10 stretches per session, thrice per week, for 6 weeks 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patient with lateral elbow pain (lateral epicondylitis)
2.Duration : Two weeks and above
3.Age group (21-40)years of Age(both gender)
 
 
ExclusionCriteria 
Details  1.Patient with a recent history of fracture,
2.Elbow & wrist instability
3.Open wound
4.Active infection
5.Previous elbow surgery
6.Rheumatoid arthritis
7.Corticosteroid injection on elbow within 6months
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.VAS
2.Inclinometer
3.Hand-held dynamometer
4.DASH scale
5.Musculoskeletal ultrasound
 		 1) VAS-Baseline and 6th week
2)Dynamometer-Baseline and 6th week
3)Musculoskeletal ultrasound-Baseline and 6th week
4)Dynamometer-Baseline and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Disability of arm, shoulder and hand questionnaire- English and Tamil  Disability of arm, shoulder and hand questionnaire- English and Tamil-Baseline & 6TH Week 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   N/A 
Date of First Enrollment (India)   17/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   A Study to analyze the effect of plyometric exercise training among patients with lateral elbow pain 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Lateral epicondylitis(LE) commonly known as tennis elbow. It is referred to the inflammation of common wrist extensor group of the muscles especially an extensor carpi radialis brevis muscles.
Apporoximately 1-3% of the general population suffers from LE, with the dominant arm commonly affected. contractile overloads that chronically stress the tendon near the attachment on the humerus are the primary cause of LE. It occurs in repetitive upper extremity activities such as computer use, heavy lifting, forceful forearm pronation and supination, and repetitive vibration.
plyometric training also called stretch-shortening drills, employs high-velocity eccentric to concentric muscle loading, reflexive reactions, and functional movements patterns. The evidence to support the effectiveness of plyometric training for developing muscle strength and power is substantial. There is also evidences indicating that plyometric training is associated with an increase in a muscle’s ability to resist stretch, which may enhance physical performance.
plyometric exercises in the rehabilitation protocol for LE can be beneficial as it reduce the recurrance rate and improving the muscle strength and power

NEED FOR THE STUDY: The main complaint in LE is pain, decreased grip strength & upper extremity functions which may in turn affect activities of daily living. Since the conventional program have been addressing that there could be better improvement of function with other methods of treatment. conventional treatment resulting in slower recovery of function, so its unique attempt to include plyometric exercise program as a intervention for lateral elbow pain due to minimal literature.
Hence it was aims primarily to use plyometric as a intervention
AIM: To compare the effect of plyometric exercise over conventional exercise among patients with lateral epicondylitis.
OBJECTIVES: To determine & compare the effect of plyometric exercises over conventional exercises on pain, grip strength & functional performance in study participants with lateral epicondylitis.
CONCLUSION: The experimental group which include plyometric exercises were significant in marked reduction of pain intensity after, increasing the grip strength, improving functional performance and improvement or normalization of the tendon image as demonstrated by decreasing thickness and improvement and a recovered homogenous tendon structure in lateral epicondylitis.




 

 
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