| CTRI Number |
CTRI/2023/02/049731 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study about the effectiveness of shoulder muscle electrical current stimulation therapy in patients having torn and weak shoulder muscle tendons from long time. |
|
Scientific Title of Study
|
To study effectiveness of Neuromuscular electrical stimulation in reversibility of fatty infiltration and muscle atrophy in chronic retracted Supraspintus tears |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHARAD PRABHAKAR |
| Designation |
PROFESSOR |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH , CHANDIGARH |
| Address |
DEPARTMENT OF ORTHOPAEDICS
NEHRU BUILDING , LEVEL -1
ROOM NO.15
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09781716119 |
| Fax |
|
| Email |
sharad.ortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHARAD PRABHAKAR |
| Designation |
PROFESSOR |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH , CHANDIGARH |
| Address |
DEPARTMENT OF ORTHOPAEDICS
NEHRU BUILDING , LEVEL -1
ROOM NO.15
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09781716119 |
| Fax |
|
| Email |
sharad.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHRINIVAS V B |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH , CHANDIGARH |
| Address |
ROOM NO.15 ,DEPARTMENT OF ORTHOPAEDICS
NEHRU BUILDING , BLOCK B
FLOOR LEVEL 1
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9448966595 |
| Fax |
|
| Email |
shrinivasvb18@gmail.com |
|
|
Source of Monetary or Material Support
|
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH , CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SHARAD PRABHAKAR |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
ROOM NO.15 ,DEPARTMENT OF ORTHOPAEDICS
NEHRU BUILDING , BLOCK B
FLOOR LEVEL 1
PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH |
09781716119
sharad.ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M668||Spontaneous rupture of other tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEUROMUSCULAR ELECTRICAL STIMULATION |
NEUROMUSCULAR ELECTRICAL STIMULATION WILL BE GIVEN AT A FREQUENCY OF 50 PULSES PER SECOND (MONOPHASIC PULSED CURRENT) WITH PULSE LENGTH OF 300 MICROSECONDS FOR A DURATION OF 15 MINS PER SESSION. THE THERAPY WILL BE FOR PERIOD OF 10 DAYS , THEN A GAP OF 10 DAYS FOLLOWED BY ANOTHER CYCLE OF STIMULATION FOR 10 DAYS. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Skeletally mature adults of either sex, aged 18 to 75 years with chronic retracted SS tears
with fatty infiltration( gd > 1 , according to Goutallier classification or Fusch’s modification
of Goutelliar grading based on MRI) of either degenerative or traumatic etiology. |
|
| ExclusionCriteria |
| Details |
1. Arthritis of shoulder joint (osteoarthritis, rheumatoid, arthritis, rotator cuff arthropathy)
2. Brachial plexus injury or any nerve involvement of upper limb like stroke
3. Frozen shoulder following trauma or shoulder surgeries, metabolic conditions (excluding
diabetes with controlled sugars who were included), stroke or myocardial infarction
4. Patients who underwent arthroscopic repair for rotator cuff tears on same side
5. Patient who withholds consent.
6. Any patient who cannot provide the necessary data due to any disability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see percentage improvement in fatty infiltration using Goutallier’s staging system and muscle atrophy
by Thomazeu’s grading system using occupation ratio in chronic retracted Supraspinatus tears following
Neuromuscular electrical stimulation. |
To see Improvement in Muscle growth and reduction in fatty content by DAY 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To see clinical improvement following Nuromuscular Electrical Stimulation in patients with chronic retracted Supraspintus tears in terms of Visual Analogue score(VAS) .
2.To see clinical improvement following Neuromuscular Electrical Stimulation (NMES) in patients with chronic Supraspintus tears in terms of Active ROM , Shoulder Pain and Diasability Index (SPADI) and Constant Score |
To see improvement in Visual Analogue Score(VAS), shoulder pain and Disability Index (SPADI) and Constant Score on Day 10 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
20/02/2023 |
| 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="1"
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
|
A Prospective Study to see effectiveness of Neuromuscular Electrical Stimulation in reversibility of fatty infiltration and muscle atrophy seen in chronic retracted Supraspinatus tears either due to traumtic or degenerative etiology in skeletally mature patients aged 18-75 years. The primary objective is to see improvement in fatty infiltration using Goutallier’s staging system and muscle atrophy by Thomazeu’s grading system using Occupation ratio on day 30. The Secondary Objective is to see clinical improvement following Electrical Stimulation in terms of Visual Analogue Score (VAS) , active range of motion (ROM) , Shoilder pain and Disability index (SPADI) and Constant Score on day 10 and day 30. |