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 |
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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 |
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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
|
|
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
|
|
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
|
|
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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