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CTRI Number  CTRI/2025/01/079430 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
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   Effects of Motor Control Exercise Combine with Proprioceptive Neuromuscular Facilitation (PNF) in Frozen Shoulder Patients 
Scientific Title of Study   Effects of Motor Control Exercise combine with PNF on Pain and Disability in patient with Frozen Shoulder 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samruddhi Rajendra Gholap 
Designation  UG Student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Orthopedic Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 Ahmadnagar MAHARASHTRA 413736 India

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7447289577  
Fax    
Email  shivsamruddhii@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Samruddhi Rajendra Gholap 
Designation  UG Student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Orthopedic Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 Ahmadnagar MAHARASHTRA 413736 India


MAHARASHTRA
413736
India 
Phone  7447289577  
Fax    
Email  shivsamruddhii@gmail.com  
 
Details of Contact Person
Public Query  
Name  Samruddhi Rajendra Gholap 
Designation  UG Student 
Affiliation  Pravara Institute Of Medical Sciences 
Address  Orthopedic Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 Ahmadnagar MAHARASHTRA 413736 India


MAHARASHTRA
413736
India 
Phone  7447289577  
Fax    
Email  shivsamruddhii@gmail.com  
 
Source of Monetary or Material Support  
Orthopedic Physiotherapy Department, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,Ahmadnagar,413736 Ahmadnagar MAHARASHTRA 413736 India  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Samruddhi Gholap   Dr. APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences  Orthopaedic Physiotherapy Department Room no 1 Dr APJ Abdul Kalam College Of Physiotherapy Pravara Institute Of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra 413736 Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA 		 7447289577

shivsamruddhii@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Dr. APJAK college of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  coventional exercises  Type and Duration of the treatment Exercise duration Exercise protocol Frozen shoulder exercise along with conventional therapy Frequency:-5 days per week (5 Rep X 2 Set of each exercise) Intensity :- 30 sec hold Time:- 30 min Type:- Frozen shoulder exercise 1. Warm up exercise (5min) i) Biceps stretch ii) Triceps stretch iii) Trapezius stretch 2.Exercise Protocol (20 min) A)Frozen Shoulder exercises i) Active range on motion for shoulder ii) Finger ladder iii) codman’s exercise iv) shoulder isometrics v) Wand Exercise vi) TENS vii) Ultrasound 3. Cool Down Exercise (5 min) i)Pectoral stretching  
Intervention  Motor control exercise along with PNF in patients with frozen shoulder  Motor control exercisee combined with PNF along with conventional treatment Component Motion Of PNF patterns for Shoulder Joints D1 Flexion D1 Extension D2 Flexion D2 Extension Shoulder Flexion adduction external rotation Extension-abductioninternal rotation Flexion-abduction external rotation Extension-adduction internal rotation Scapula Elevation, abduction, upward rotation Depression, adduction, downward rotation Elevation, abduction, upward rotation Depression, adduction downward rotation Elbow Flexion or extension Flexion or extension Flexion or extension Flexion or extension Forearm Supination Pronation Supination Pronation Wrist Flexion, radial deviation Extension, ulnar deviation Extension, radial deviation Flexion, ulnar deviation Finger Flexion, adduction Extension,abduction Extension,abduction Flexion,adduction  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age group from 35-65 years.
2)Both male and female.
3)Restricted range of motion in capsular pattern which is external rotation, abduction, internal rotation.
4)Diagnosed case of frozen shoulder (Stage 1, 2 and 3)
6) Those willing to participate.
 
 
ExclusionCriteria 
Details  1)Patients having history of fracture, shoulder injury, or any other trauma, surgery.
2)Patients with external rotator cuff injury.
3)Patients having infection or osteoarthritis.
4)Patients having cervical radiculopathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Frozen Shoulder - Shoulder Pain and Disability Index (SPADI)
2.Pain - Visual Analouge Scale (VAS)
3.ROM OF SHOULDER - RANGE OF MOTION (ROM) by using Universal Goniometer 		 Baseline week 0 and post-intervention week 2 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analouge Scale (VAS)  Baseline week 0 and post-intervention week 2 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/02/2025 
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 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  

Frozen shoulder is a condition of uncertain aetiology, characterized by significant restriction of both active and passive shoulder motion that occur in the absence of a known intrinsic shoulder disorder. The condition was first clinically recognized as “periarthritis scapula-humeral” by Duplay in 1872. However, Codman in 1934 described it as frozen shoulder, indicating the possibility of developing shoulder stiffness and pain without the influence of external factors. “Adhesive capsulitis”, indicating a pathology in the glenohumeral capsule, was coined by Neviaser. Adhesive capsulitis is the leading cause of pain at the shoulder joint in middle aged and elderly persons. Adhesive capsulitis, another name for frozen shoulder, is a common ailment affecting the glenohumeral joint that causes the joint capsule to progressively swell and cause the shoulder to become stiff. In the general population, 2 to 5 percent of people are expected to have frozen shoulder at some point in their lifespan.MATERIAL AND METHODOLOGY:Study setting: This study will be conducted in the Department of Orthopedic Physiotherapy DR.APJ Abdul Kalam Collage of Physiotherapy, PMT-PIMS, LONI. â€¢Type Study: Randomised Control Trial â€¢Source of data: Sample will be collected from Pravara Rural Hospital, Loni â€¢Sample size:50 â€¢Study Population: Patients with frozen shoulder â€¢Study duration:6 weeks Â·  Material to be used:Consent form, Data collection sheet


   

 

 

 

 

 

 

 

 

 

 


 

 


 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 





 


                    

Type and Duration of the treatment

Exercise duration

Exercise protocol

Frozen shoulder exercise along with conventional therapy

Frequency:-5 days per week (5 Rep X 2 Set of each exercise)

Intensity :- 30 sec hold

Time:- 30 min

Type:- Frozen shoulder exercise

1.  Warm up exercise (5min)

i) Biceps stretch

ii) Triceps stretch

iii) Trapezius stretch

2. Exercise Protocol (20 min)

   A)Frozen Shoulder exercises

i) Active range on motion for shoulder

ii) Finger ladder

iii) codman’s exercise

iv) shoulder isometrics

v) Wand Exercise

vi) TENS    

vii) Ultrasound

3. Cool Down Exercise (5 min)

i)Pectoral stretching

 

Motor control exercise combined with PNF along with conventional treatment

[13]

Component Motion Of PNF patterns for Shoulder

Joints

D1 Flexion

D1 Extension

D2 Flexion

D2 Extension

Shoulder

Flexion-adductionexternal rotatio

Extension-abductioninternal rotation

Flexion-abductionexternal rotation

Extension-adductioninternal rotation

Scapula

Elevation, abduction,

upward rotation

Depression, adduction,

downward rotation

Elevation, abduction,

upward rotation

Depression, adduction

downward rotation

Elbow

Flexion or extension

Flexion or extension

Flexion or extension

Flexion or extension

Forearm

Supination

Pronation

Supination

Pronation

Wrist

Flexion, radial

deviation

Extension, ulnar

deviation

Extension, radial

deviation

Flexion, ulnar

deviation

Finger

Flexion, adduction

Extension,abduction

Extension,abduction

Flexion,adduction

 
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