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CTRI Number  CTRI/2018/05/013892 [Registered on: 15/05/2018] Trial Registered Retrospectively
Last Modified On: 09/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Physiotherapy treatment of shoulder pain in sports persons 
Scientific Title of Study   Physiotherapy management of shoulder impingement syndrome in overhead athletes :An EMG – evaluative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ejaz Hussain 
Designation  DIRECTOR AND PROFESSOR 
Affiliation  jamia millia islamia 
Address  centre for physiotherapy and rehabilitation sciences jamia millia islamia

South
DELHI
110025
India 
Phone  91-9899339816  
Fax    
Email  ehusain@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Saurabh Sharma 
Designation  Asst professor 
Affiliation  jamia millia islamia 
Address  Centre for physiotherapy and rehabilitation sciences

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Saurabh Sharma 
Designation  Asst professor 
Affiliation  jamia millia islamia 
Address  Centre for physiotherapy and rehabilitation sciences, JMI

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Source of Monetary or Material Support  
Centre for physiotherapy and rehabilitation sciences jamia millia islamia New delhi 
 
Primary Sponsor  
Name  centre for physiotherapy and rehabilitation sciences 
Address  jamia millia islamia , new delhi 
Type of Sponsor  Other [central university] 
 
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 
Prof Ejaz Hussain  Jamia millia islamia   Centre for physiotherapy and rehabilitation sciences , room number 101(directors room)
South
DELHI 		 9899339816

ehusain@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  shoulder impingement syndrome(athletes) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control exercise program  The total duration of the treatment was 8 weeks. The control exercise programme consisted of six unspecific movement exercises for the neck and shoulder without any external load (shoulder abduction in the frontal plane, shoulder retraction, shoulder elevation, neck retraction, stretch of upper trapezius and pectoralis major. Each movement exercise was repeated 10 times, and each stretching exercise three times twice daily at home and once every other week at the physiotherapist visits. The patients did the same programme without any progression during the whole rehabilitation period. The unspecific exercise programme was thought to have a limited effect in patients with subacromial impingement syndrome and therefore acted as a control.  
Intervention  Experimental group  The total duration of the exercise protocol was 8 weeks.Subjects in this arm did the evidence based synthesized protocol for 8 weeks framed by amalgamation of protocols from authors of previous studies. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Participants who satisfy the following criteria will be recruited to participate
1) Age between 17-35 years
2) Overhead athletes playing competitive sports like volleyball , tennis ,baseball , cricket , swimming , badminton , basketball for at least 6 hours a week .
3) The following diagnostic criteria was used as used in previous studies 8
Patients were included in the impingement group if they had at least two of the following five criteria,
a) Positive Neer sign, reproduction of pain when the examiner passively flexed the humerus to end range with overpressure;
b) Positive Hawkins sign, reproduction of pain when the shoulder was passively placed in 90° of forward flexion and internally rotated to end range.
c) Positive Jobe’s sign, reproduction of pain and lack of force production with isometric elevation in the scapular plane in internal rotation (empty can);
d) Pain with apprehension, reproduction of pain when an anteriorly directed force was applied to the proximal humerus in the position of 90° of abduction and 90° of external rotation
e) Positive relocation, reduction of pain after a positive apprehension test when a posteriorly directed force was applied to the proximal humerus in the position of 90° of abduction and 90° of external rotation

No subjects will be included in the study based on last 2 criteria alone.

4) Duration of shoulder impingement for at least 1 month.

5) Pain rating on VAS of less than or equal to 7/10.

6) Willing to commit to a 8 week supervised physiotherapy program.
 
 
ExclusionCriteria 
Details  1) Subjects who had dislocation in the same or opposite shoulder priorly.
2) Subjects who have isolated AC Joint pathology which is reproduced with AC joint palpation.
3) Symptoms from cervical spine ie radiculopathy.
4) Subjects currently on medication like NSAIDs or received steroid injection in past 12 months etc.
5) Subjects with prior shoulder surgery on symptomatic side.
6) Full thickness rotator cuff tear evidenced by drop test.

 
 
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 
1.EMG RECORDING-%MVIC
2.EMG RECORDING- Muscle latency timing
3.Isometric muscle strength by hand held dynamaometer
 		 basline
4th week
8th week 
 
Secondary Outcome  
Outcome  TimePoints 
1. SPADI scale /QoL questionnaire
2. AHD(acromiohumeral distance) measurement by ultrasound .

 		 basline
4th week
8th week 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   08/04/2014 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomised , single blinded , parallel group,to ascertain the effects of physiotherapeutic management on the shoulder impingement syndrome in overhead athletes.the overhead athletes are being recruited from university teams of jamia millia islamia , new delhi .the study is being conducted at centre for physiotherapy and rehabiitation sciences , jamia millia islamia .the primary outcome measures will be EMG recordings of %MVIC,Latency timimg and isometric muscle strength .the secondary outcomes will be SPADI Scale/Qol  and AHD(acromiohumeral distance) measurement by ultrasound. 
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