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CTRI Number  CTRI/2024/01/061843 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 28/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bilateral versus unilateral training in shoulder pain 
Scientific Title of Study   Effectiveness of Bilateral sensorimotor training on upper quadrant function and quality of life in individuals with unilateral rotator cuff related shoulder pain - A randomized controlled trial 
Trial Acronym  BILAT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha Vishal 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576101
India 
Phone  9986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Kavitha Vishal 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576101
India 
Phone  9986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  G Arun maiya  
Designation  Professor  
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  garunmaiya@gmail.com  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education Madhav Nagar Manipal, Karnataka,India  
 
Primary Sponsor  
Name  Kavitha Vishal 
Address  Department of Physiotherapy Manipal College of Health professions Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavitha Vishal  Kasturba Hospital,Manipal  Department of Physiotherapy Hand therapy room Outpatient Unit Madhav Nagar Manipal
Udupi
KARNATAKA 
9986526077

vishalkavitha84@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Control Group   Exercises will be only given to the side of rotator cuff related shoulder pain The sessions will include 10 supervised sessions for 12 weeks. Additionally, they will be provided a home program. Total duration of intervention is 12 weeks.  
Intervention  Experimental group   Exercises will be given Bilateral sensorimotor training to both sides of the upper limb in individuals with unilateral rotator cuff related shoulder pain. Additionally, they will provided home exercise program. The sessions will include 10 supervised sessions for 12 weeks. Total duration of intervention is 12 weeks.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Complains of shoulder pain unilaterally
Positive Hawkins kennedy
Positive Neer impingememt
Postive external rotation stress test  
 
ExclusionCriteria 
Details  Bilateral shoulder pain
Adhesive capsultis
Recent surgery
Cardiopulmaory, inflammatory and neurological conditions affecting the upper extremity
Neck pain
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Upper limb function
Quality of Life  
Baseline and 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
shoulder pain during rest and activity
Shoulder muscle strength
Pressure Pain thresholds
Shoulder proprioception
Shoulder function 
Baseline and 12 weeks 
 
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)   03/02/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  

Primary objective: To evaluate the effectiveness of a bilateral sensorimotor training program compared to standard training on upper quadrant function (DASH) and quality of life (WORC) in Individuals with unilateral RCRSP.

 

Secondary objective: To compare the effectiveness of bilateral sensorimotor training compared to standard training on pain intensity (NPRS), pain sensitivity (PPT), active range of motion (ROM), shoulder muscle strength (isometric muscle strength), shoulder joint proprioception (passive to active joint position error), and shoulder function (CMS score).

 

Interventions -both the groups

Both the groups will undergo clinical examination including a thorough subjective and physical examination of the shoulder and the spine by the treating physiotherapist.   

Participants will be asked about the burden of shoulder pain using a semi- structured interview guide until thematic saturation. Data will be analyzed qualitatively using themes and subthemes. The interview will be conducted in English and Kannada. Themes derived will be used to understand the burden and lived experience of shoulder pain. 

The treatment protocol will be pragmatically delivered based on the clinical examination findings. The experimental group will receive bilateral sensorimotor training (exercises on the involved and the uninvolved side). The control group will receive standard training (exercises only on the involved side). In addition, both the groups will receive education, modalities (heat/cold) stretching exercises, posture correction and mobilization of the glenohumeral joint if indicated.   To ensure uniformity in prescription of intervention both the groups will receive same number of sessions and dosages.  

Both groups will receive a total of 10 supervised sessions over the 12-week period, with each session lasting 45 minutes. The supervised sessions will be scheduled once per week for the first six weeks, followed by four additional sessions spread over the remaining six weeks. In addition to the supervised sessions, participants will perform a home exercise program independently once per day, six days a week, for 12 weeks as per their group assignment

Experimental group

Participants in the EG received bilateral sensorimotor training. They will perform strengthening, motor control, and proprioceptive exercises on the involved and the uninvolved side simultaneously. 

The exercise program will be structured into three progressive stages of increasing difficulty, determined by the degree of humeral elevation and greater activity of the RC. Each stage will have general strengthening, rotator cuff-specific strengthening, motor control training, and proprioceptive exercises.

Control group

Participants in the CG performed standard training on the involved side. The intervention will be usual care provided to patients with RCRSP, including strengthening and/or motor control exercise and proprioceptive exercises, based on the physical examination findings performed only on the involved side. Exercise prescription will be guided by the participant’s adaptive response and pain behaviour of the involved limb.

Outcomes will be assessed at three time points, baseline, 6 weeks and 12 weeks 

 


 
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