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CTRI Number  CTRI/2024/11/077492 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Optimizing outcome in rotator cuff repair: The role of postoperative deltoid muscle stimulation for improved pain and function - A randomized control study  
Scientific Title of Study   Optimizing Post rotator cuff repair outcomes: The role of deltoid muscle stimulation in pain and function improvement - A randomized control study  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Senthilvelan R 
Designation  HOD shoulder elbow and wrist surgery 
Affiliation  Miot intenational 
Address  Shoulder surgery unit, Department of orthopaedics, Orthopaedic OPD block, MIOT HOSPITAL, MANAPAKKAM

Chennai
TAMIL NADU
600089
India 
Phone  9566222533  
Fax    
Email  velansenthil78@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. ROBIN G ALEX 
Designation  Fellowship trainee 
Affiliation  Miot international 
Address  Shoulder surgery unit Miot international hospital, Manapakkam Chennai

Chennai
TAMIL NADU
600089
India 
Phone  8089118524  
Fax    
Email  robinrosary@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.ROBIN G ALEX 
Designation  Fellowship trainee 
Affiliation  Miot international 
Address  Shoulder surgery unit, Miot international hospital, Manapakkam Chennai


TAMIL NADU
600089
India 
Phone  8089118524  
Fax    
Email  robinrosary@gmail.com  
 
Source of Monetary or Material Support  
Miot International Hsopital, Manapakkam, Chennai 600089 India 
 
Primary Sponsor  
Name  no sponsor 
Address  NA 
Type of Sponsor  Other [NO SPONSORS] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ROBIN G ALEX  MIOT INTERNATIONAL HOSPITAL  Shoulder surgery unit, Department of orthopaedics, Orthopaedics OPD block, MIOT HOSPITAL, MANAPAKKAM, CHENNAI
Chennai
TAMIL NADU 		 8089118524

robinrosary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Miot International Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M621||Other rupture of muscle (nontraumatic),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deltoid muscle stimulation will be given after rotator cuff repair to the patients in this group.  A portable EMS (EMS+T; HMS Medical system, Chennai, India) will be used for the muscle stimulation intervention. This stimulator will be practical for home use. We have been using the stimulator quite frequently for the past few weeks without any complications. During stimulation, self-adherent, flexible rectangular electrodes will be placed on the anterior, middle, and posterior portions of the deltoid muscle, and will be marked to ensure consistent reapplication by the participant. Muscle stimulation from the portable electrical stimulator will be applied to the resting muscle, and the participant will be instructed to relax during the induced muscle contraction. The intensity will be set to the maximal intensity tolerated during each session with noticeable muscle twitching, and participants will be repeatedly encouraged to increase the intensity as tolerated. The stimulator will be set to deliver a surged faradic current, using a triangular surge pattern waveform, at 50-100Hz for 5 seconds (including a 2.5 seconds ramp-up time and a 2 seconds ramp-down time) and a 5 seconds off time with pulse duration of 0.1 to 1ms. Total duration of the therapy will be 15 minutes. These interventions will be initiated 24 hours after surgery. An emphasis will be placed on the importance of using the stimulator at a tolerable but slightly uncomfortable intensity, although there will be no minimum intensity required for the study protocol. Moreover, the participants will be repeatedly instructed to continue increasing to a tolerable intensity within and between sessions. Most participants will demonstrate safe and proper use of the stimulator in the hospital. All patients will be asked to visit the hospital at 2 weeks, 6 weeks, 3 months and 6 months from the date of surgery and we will verify appropriate usage as instructed. Total duration of the therapy will be upto 6 weeks from the date of surgery. Daily stimulation till 2 weeks and alternate day stimulation from 2 weeks up to 6 weeks. Patients in the first group will be asked to maintain a logbook to check whether they have undergone the stimulation at least once a day. They shall also record their VAS pain scale every day. The control group won’t be subjected to the stimulation intervention. All other aspects of rehabilitation will be kept similar between the two groups. The patient will be reviewed and VAS pain score, ROM and oxford Shoulder score shall be recorded in the department periodically at two weeks, six weeks and three months. Preoperative MRI will be compared with the 6 months Postoperative MRI to assess the deltoid muscle thickness; whether it has improved, remained the same or deteriorated. This intervention will be in addition to the routine physiotherapy protocol provided to all the rotator cuff repair patient 
Comparator Agent  No deltoid muscle stimulation will be provided to this group of patients who underwent rotator cuff repair surgery  All aspect of the rehabilitation will be similar between the two groups except for the deltoid muscle stimulation. VAS score, ROM and Oxford score will be recorded at 2 weeks, 6 weeks and 3 months from the date of surgery. Preoperative MRI will be compared with the 6months post-operative MRI to assess the deltoid muscle thickness.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Rotator cuff tear medium-sized(1-3cm) rotator cuff tears planned for arthroscopic repair surgery and patient age between 40 and 75 years.  
 
ExclusionCriteria 
Details  The exclusion criteria were incomplete repair of the footprint, preoperative fatty degeneration of the deltoid muscle, poor understanding of the stimulation devices (muscle stimulation), and refusal to participate in the study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
vas score
oxford shoulder score
range of movements 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
deltoid thickness using MRI   6months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   10/12/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [robinrosary@gmail.com].

  6. For how long will this data be available start date provided 26-11-2025 and end date provided 26-10-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Deltoid muscle stimulation after rotator cuff repair during post-operative period can help with pain and functional improvement in patients. we are planning to conduct a randomised study by assessing the pain, range of movements and oxford functional score in patients who undergo postopeative deltoid muscle stimulation and in patients who do not undergo post-operative muscle stimulation. Muscle stimulation devices are being used for long time in physiotherapy and we plan to look at the effect of focussed muscle stimulation in rotator cuff repair patients. We also plan to compare the thickness of deltoid muscle thickness between the preopeative MRI and 6 months post-operative MRI. We believe this study could help in giving better directions for rotator cuff rehabilitation. 
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