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CTRI Number  CTRI/2024/07/069728 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Physiotherapy management for shoulder pain ,without the surgical treatment. 
Scientific Title of Study   Comparative effect of shockwave therapy and low level laser therapy with dynamic loading exercise over conventional exercise program on rotator cuff tendinitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nithyanisha.R 
Designation  Assistant Professor. 
Affiliation  Dr Mgr educational and research institute 
Address  Faculty of Physiotherapy, Department of Orthopaedics. Dr.Mgr educational and research institute,Chennai.
Faculty of physiotherapy, Department of orthopaedics. Dr mgr educational and research institute.
Thiruvallur
TAMIL NADU
77
India 
Phone  9790911759  
Fax    
Email  nithyanisha.physio@drmgrdu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Nithyanisha R 
Designation  Assistant Professor. 
Affiliation  Dr Mgr educational and research institute 
Address  Faculty of Physiotherapy ,Department of Orthopaedics, Dr mgr educational and research institute,Chennai.
Faculty of Physiotherapy ,Department of Orthopaedics, Dr Mgr educational and research institute,Chennai.
Thiruvallur
TAMIL NADU
77
India 
Phone  9790911759  
Fax    
Email  nithyanisha.physio@drmgrdu.ac.in  
 
Details of Contact Person
Public Query  
Name  Nithyanisha R 
Designation  Assistant Professor. 
Affiliation  Dr Mgr educational and research institute 
Address  Faculty of Physiotherapy, Department of orthopaedics, Dr Mgr educational and research institute,Chennai.
Faculty of physiotherapy, Department of orthopaedics, Dr Mgr educational and research institute,Chennai.
Thiruvallur
TAMIL NADU
77
India 
Phone  9790911759  
Fax    
Email  nithyanisha.physio@drmgrdu.ac.in  
 
Source of Monetary or Material Support  
0utpatient physiotherapy department,faculty of physiotherapy,acs medical college and hospital,vellappanchavadi,chennai-77. 
 
Primary Sponsor  
Name  Dr Mgr educational and research Institute Faculty of physiotherapy Department of orthopaedics 
Address  Dr Mgr educational and research Institute, Faculty of physiotherapy, Department of orthopaedics.  
Type of Sponsor  Research institution 
 
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 
Nithyanisha R  Acs Mediacl College and Hospital.  faculty of physiotherapy,department of orthopaedics,drmgr educational and research institute.
Thiruvallur
TAMIL NADU 		 9790911759

nithyanisha.physio@drmgrdu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Shock wave Therapy 4 weeks, Low Level laser therapy 4weeks and Dynamic loading exercises 4weeks.   Shock wave Therapy 4 weeks, Low Level laser therapy 4weeks and Dynamic loading exercises 4weeks. 
Comparator Agent  Shock Wave Therapy and Low Level Laser Therapy.  Shock Wave Therapy and Low Level Laser Therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  . Patients with clinically diagnosed with rotator cuff tendinitis will be fully considered for inclusion with any restrictions.
2. Age group between 18-60 years.
3. Gender ( both male and female ).
4. Painful arc syndrome, Positive empty can test , History of clinical signs of chronic tendinitis for more than 6 months.
5.Patient between Body mass index of 19-25 kg/m2 
 
ExclusionCriteria 
Details  Pregnant women, 2.Blood coagulation disorders.
3. History of surgery, History or presence of tumors.
Cardiac disease. 5.Frozen shoulder.
6. Systematic diseases. 7.Skin disease.
Cancer.9.Severe mental disorders.
10. Recent fracture and dislocation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain

Muscle tissue morphology (Muscle tissue thickness in mm).

Functions of shoulder joint.

Range of motion -shoulder abduction/lateral rotation.
 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Test- Serum Cortisol.
Ultrasonogram.
Shoulder pain & disability index(SPADI)
Digital electronic goniometer.
 		 4 weeks 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   11/07/2024 
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="1"
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 - NO
Brief Summary  

Aim of the study is to find the COMPARATIVE EFFECT OF SHOCK WAVE THERAPY
AND LOW LEVEL LASER THERAPY WITH DYNAMIC
LOADING EXERCISE OVER CONVENTIONAL
EXERCISE PROGRAM ON ROTATOR CUFF TENDINITIS  on rotator cuff
tendinitis.
BACKGROUND:
Shoulder pain is the third most common musculoskeletal complaint encountered in clinical
practice. Out of that, rotator cuff tendinitis is one of the causes of shoulder pain. The
symptoms of rotator cuff tendinitis include pain and swelling in the shoulder area, limited
motion or weakness of the arm. Rotator cuff tendinitis usually occurs over time after repeated
stress on the rotator cuff.
METHODOLOGY:
Study Design: experimental study
Study Type: Comparative type (pre and post type)
Study Setting: Out patient department, Faculty of Physiotherapy, Acs Medical College And
Hospital.

Sample size: 175 subjects
 Group A: :Extracorporeal shock wave therapy with dynamic loading exercise
programme.
 Group B: Low level laser therapy with dynamic loading exercise programme.
 Group C: ultrasound with dynamic loading exercise program.
Study Sampling Method: Simple random sampling method
Study Duration: 1year
selection Criteria:
 Inclusion criteria:
 Patients with clinically diagnosed with rotator cuff tendinitis will be fully considered for
inclusion with any restrictions.
 Age group between 18-60 years.
 Gender (both male and female).
 Painful arc syndrome, Positive empty can test, History of clinical signs of chronic
tendinitis for more than 6 months.
Patient between Body mass index of 19-25 kg/m2.
 Exclusion criteria:
 Pregnant women
 Blood coagulation disorders.
 History of surgery, History or presence of tumors.
 Cardiac disease.
Frozen shoulder.
 Systematic diseases.
Skin disease.
 Cancer.
Severe mental disorders.
 Recent fracture and dislocation.
OUTCOME MEASURES:
 Pain

 Muscle tissue morphology (Muscle tissue thickness in mm).
 Functions of shoulder joint.
 Range of motion – shoulder abduction/latera
MEASUREMENT TOOLS:
 Blood Test-Serum Cortisol
 Ultrasonongram
 Shoulder pain and disability index (SPADI)
Digital electronic goniometer.
 
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