| CTRI Number |
CTRI/2023/04/051378 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Core muscle and Shoulder Pain |
|
Scientific Title of Study
|
Evaluation of core muscle endurance in subjects 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 |
Milone Savla |
| Designation |
Postgraduate student |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
KMC Hospital Attavar, Department of Physiotherapy, Nandigudda road Attavar, Manglore, Karnataka
Kasturba Medical college, Lighthouse Hillroad, Hampankatta, Manglore, Karnataka, 575001.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9321585356 |
| Fax |
|
| Email |
milone.kmcmlr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
Kasturba Medical College Hospital, Department of Physiotherapy, Nandigudda road, Attavar, Manglore, 575001, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Eapen |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manglore |
| Address |
Kasturba Medical College Hospital, Department of Physiotherapy,Nandigudda road, Attavar, Manglore, 575001, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital, Attavar |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Milone Savla |
Kasturba Medical College Hospital, Attavar |
Kasturba Medical College Hospital, Nandigudda road, Attavar, Manglore, Karnataka 575001
Dakshina Kannada
KARNATAKA |
9321585356
milone.kmcmlr2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Manglaore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
For shoulder joint pain group:
1) Age 18 years and above.
2) Willingness to participate in the study.
3) Patients who have shoulder pain.
For the control group:
1) Age 18 years and above.
2) No history of a shoulder injury or surgery.
|
|
| ExclusionCriteria |
| Details |
For both groups:
1) Neurological problems affecting the upper
extremity.
2) History of past shoulder injury or surgery
within 6 months.
3) History of radiating neck pain.
4) Previous lumbar pathology or surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand-Held Dynamometer to assess strength of Shoulder and Scapular Muscles
Universal Goniometer for Range Of Motion of Shoulder joint
Shoulder Pain and Disability Index. (SPADI)
Numeric Pain Rating Scale (NPRS) for rating Pain At Shoulder Joint
|
The above mentioned Outcome Measures will be assessed only once at baseline when the subjects come to Physiotherapy OPD and IPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mc Gills Testing Procedure for assessing Core Muscle Endurance |
The above mentioned Outcome Measures will be assessed once at baseline when the subjects come to Physiotherapy OPD and IPD |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/04/2023 |
| 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="2"
Months="0"
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
|
Considering the inclusion and exclusion criteria, the eligible subjects will be selected. Initially the demographic data will be take, Clinical and Functional evaluation will be done using the above mentioned Outcome Measures.
|