| CTRI Number |
CTRI/2025/07/091104 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To identify any change of sensation in people with shoulder pain when compared with people without shoulder pain |
|
Scientific Title of Study
|
Comparison of tactile acuity, left-right discrimination and temporal summation in individuals with and without rotator-cuff related shoulder pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tushar |
| Designation |
Post graduate student - MPT |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Room number: 215, 2nd floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09470217667 |
| Fax |
|
| Email |
tushar.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Anupama Prabhu B |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Room number: 215, 2nd floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Aditya Jadhav |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Room number: 215, 2nd floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7829500469 |
| Fax |
|
| Email |
radhika.aj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Room number: 215, 2nd floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. 576104 |
|
|
Primary Sponsor
|
| Name |
Tushar Self |
| Address |
Department of Physiotherapy, Room number: 215, 2nd floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India. 576104 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Tushar |
Kasturba Hospital |
N1, First floor, Department of Physiotherapy, Baliga block/ Artificial Limb Center, Kasturba Hospital, Udupi- Hebri road, Madhav Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
09470217667
tushar.mchpmpl2024@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Left-right discrimination |
Left-right differentiation means how accurately individuals can identify whether a part belongs to the left or the right side of the body. Different shoulder images of the will be displayed to the participants in different orientations using a mobile application, who then have to identify whether it belongs to the left or the right side of the body. The procedure will take around 10-15 minutes |
| Intervention |
Tactile acuity |
Tactile acuity is measured by recording the minimum distance at which two different stimuli are felt as two distinct stimuli. An aesthesiometer will be used to measure this distance, which would require around 10-15 minutes |
| Intervention |
Temporal summation |
Temporal summation refers to an increase in pain perception when the same noxious stimuli are applied repeatedly at the same intensity around the same area. A monofilament will be used as the noxious stimulus to elicit response, and the entire process will require 15 minutes |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
For rotator cuff-related shoulder pain patients:
Individuals diagnosed with unilateral acute or chronic rotator cuff-related shoulder pain
For the Control group:
Asymptomatic healthy individuals matched by age and sex
No history of musculoskeletal impairments in the last 6 months |
|
| ExclusionCriteria |
| Details |
For rotator cuff related shoulder pain:
Primary frozen shoulder
Fractures around the shoulder
Complex regional pain syndrome (CRPS)
Corticosteroid injection to the shoulder
Surgically managed rotator cuff tears
Neck pain
Any neurological conditions
Visual impairment
For the Control group:
Neurological impairment of the upper extremity (loss of sensation, muscle weakness, reflex changes)
On pain medications
Previous history of shoulder surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Two-point discrimination score
Left-right judgment score
Temporal summation score |
Baseline alone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
01/08/2025 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an Observational study that aims to investigate somatosensory integrity via tactile acuity, left-right discrimination, and temporal summation in people with acute and chronic rotator cuff-related shoulder pain and the controls. The scores will be recorded at a single point in time for tactile acuity, left-right discrimination, and temporal summation among individuals with acute, chronic rotator cuff-related shoulder pain and compare it with normal healthy individuals without shoulder pain |