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CTRI Number  CTRI/2021/05/033451 [Registered on: 07/05/2021] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation of Left and Right Discrimination task and Fear of movement with Physical performance in patients with Shoulder pain. 
Scientific Title of Study   Correlation of Laterality Discrimination task and Fear of movement with Physical performance in patients with Shoulder pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  P.T. School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  P.T. School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  P.T. School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  dipti_geete@yahoo.com  
 
Source of Monetary or Material Support  
P.T. School and Centre, Seth GSMC and KEM Hospital. 
 
Primary Sponsor  
Name  Dipti Geete 
Address  P.T. School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai- 400012. 
Type of Sponsor  Other [Self] 
 
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 
Dipti Geete  P.T. School and Centre, Seth GSMC and KEM Hospital.  OPD No.402, Physiotherapy Department, Ground floor, KEM Orthopedic Centre, Parel (E), Mumbai-400012
Mumbai
MAHARASHTRA 
9869701464

dipti_geete@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Seth G.S. Medical college and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M754||Impingement syndrome of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients experiencing chronic shoulder pain i.e. pain experienced for more than 3 months due to any shoulder pathology of non-traumatic etiology who are willing to participate in the study and are able to read and understand either of these 3 languages- English, Hindi, Marathi. 
 
ExclusionCriteria 
Details  1. Individuals experiencing pain in joints other than shoulder.
2. Individuals having Rotator Cuff tear.
3. Individuals who have been operated for any shoulder pathology.
4. Shoulder pathologies having traumatic etiologies.
5. Individuals experiencing pain due to fractures around the shoulder joint.
6. Individuals experiencing Neck pain.
7. Central nervous system affection.
8. Neuropathic pain.
9. Any Peripheral Vascular Diseases.
10. Systemic conditions like uncontrolled Diabetes Mellitus. 11. 11. Individuals suffering from Nephropathy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Laterality discrimination task/ Left-Right Judgement task to assess Accuracy (in %) and Reaction time (in msec).
2. Seated Medicine ball throw test to assess Physical performance. Throw distance will be calculated in meters.
3. Tampa Scale of Kinesiophobia- Shortened Version 11. (TSK-11) to assess fear of movement. Score ranging from 11-44 points. 
As it is a one time assessment study, the outcome measures will be assessed only once on the day of data collection for each subject. 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale (score ranging from 0-10)  As it is a one time assessment study, outcome measures will be assessed only once on the day of data collection for each subject. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/05/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Shoulder pain is a highly prevalent condition among the general population and persistent pain is common despite treatment giving rise to limitations in ADLs and restriction of participation in various other activities. In chronic pain there is cortical reorganisation of S1 that may provoke incongruence between predicted and actual sensory feedback and motor output thus negatively influencing proprioception and motor performance.
Additionally, due to this cortical reorganization of S1, the integrity of body schema (internal map which the brain uses for movement) also gets disrupted, hence, influencing the proprioceptive abilities of that region. This results in impairment of both physical performance and laterality discrimination. Data also suggests presence of fear to do movement in shoulder pain patients leading to limitations in ADLs and participation restriction, therefore causing more physical performance impairment. 
Thus, we aim to correlate Laterality discrimination task and fear of movement with physical performance in patients with shoulder pain. This information is important as these changes are considered as a potential avenue of treatment in this population. 
Laterality discrimination will be assessed using Recognise application via Noi group, physical performance using the seated medicine ball throw test and fear of movement using Tampa Scale of Kinesiophobia 11. Total 30 subjects will be recruited. The data collected will be analyzed statistically.

 
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