| CTRI Number |
CTRI/2020/03/023860 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Sensorimotor findings of upper limb with shoulder function in individuals with chronic Rotator cuff related shoulder pain |
|
Scientific Title of Study
|
Correlation of upper extremity Sensorimotor status with shoulder function in individuals with chronic Rotator cuff related 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 |
Miss Sneha Subramanian Iyer |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE,
Manipal,
Udupi
KARNATAKA
576104
India |
| Phone |
9869902129 |
| Fax |
|
| Email |
iyersnehaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant Professor (SENIOR SCALE) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions, MAHE,
Manipal,
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Miss Sneha Subramanian Iyer |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE,
Manipal,
Udupi
KARNATAKA
576104
India |
| Phone |
9869902129 |
| Fax |
|
| Email |
iyersnehaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Miss Sneha Subramanian Iyer |
| Address |
Manipal College of Health Professions, MAHE,
Manipal,
Karnataka-576104 |
| 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 |
| Miss Sneha Subramanian Iyer |
Kasturba Hospital |
N-1, Department of Physiotherapy, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9869902129
iyersnehaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Rotator cuff related shoulder pain
Duration: more than 3 months
At least 2 out of 3 special tests should be positive (Painful arc, External rotation stress test, Hawkins Kennedy test) |
|
| ExclusionCriteria |
| Details |
Full thickness tear of Rotator cuff
Previous shoulder surgery or fracture of shoulder girdle
Presence of diagnosed systemic diseases and neurologic symptoms
Previous history of dislocation.
Primary Adhesive Capsulitis
Uncontrolled Diabetes Mellitus
Cervical nerve root pathologies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disabilities of Arm, Shoulder and Hand score |
Assessed once at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale score for the unilateral shoulder at rest
|
Assessed once at the time of recruitment |
| Pressure pain threshold of entire upper extremity |
Assessed once at the time of recruitment |
| Shoulder proprioception error |
Assessed once at the time of recruitment |
| Tactile Acuity at shoulder |
Assessed once at the time of recruitment |
| Heat detection threshold at shoulder |
Assessed once at the time of recruitment |
| Cold detection threshold at shoulder |
Assessed once at the time of recruitment |
| Isometric global muscle strength of upper extremity using dynamometer |
Assessed once at the time of recruitment |
| Grip Strength |
Assessed once at the time of recruitment |
| EMG study on muscle activation pattern of entire upper extremity during grip strength at rest |
Assessed once at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
13/03/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This observational study will be conducted on individuals with unilateral chronic Rotator cuff related shoulder pain(RCRSP). Participants who present with unilateral shoulder pain in Department of Physiotherapy, Kasturba Hospital will be screened for inclusion and exclusion criteria. Written informed consent will be obtained from participants prior to assessment. A preliminary assessment involving special tests will be performed to confirm the rotator cuff involvement. The participants with chronic unilateral RCRSP will then be instructed to rate their pain on a 10 cm Numerical Pain Rating Scale (NPRS) and fill their level of disability on the Disabilities of Shoulder, Arm and Hand(DASH) questionnaire. This is a one time study involving assessment of sensory and motor functions of the involved upper extremity. Sensory functions such as Pressure pain threshold, Tactile acuity, Shoulder proprioception error, Heat and Cold detection threshold will be measured. Motor function will be assessed by checking the isometric muscle strength of upper extremity and grip strength using dynamometer. The muscle activation pattern of the upper extremity during gripping activity at rest will be examined using surface EMG electrodes. The correlation between sensorimotor status and pain with functional disability will be studied. |