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CTRI Number  CTRI/2017/04/008321 [Registered on: 10/04/2017] Trial Registered Prospectively
Last Modified On: 07/04/2017
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   A Comparative study of two types of stretching techniques on range of motion and functional activities in frozen shoulder condition 
Scientific Title of Study   A Comparative study of proprioceptive neuromuscular facilitation stretching and capsular stretching on range of motion and functional activities in frozen shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samuel dickson philip 
Designation  Post graduate student (MPT) 
Affiliation  Father muller medical college 
Address  Department of physiotherapy Father muller medical college Mangalore
Department of physiotherapy Father muller medical college Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  7406145972  
Fax    
Email  dcksnphilp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mr Sudeep MJ Pais 
Designation  Associate professor 
Affiliation  Father muller medical college 
Address  Department of physiotherapy Father muller medical college Mangalore
Department of physiotherapy Father muller medical college Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  09739867404  
Fax    
Email  sudeep_pais@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Samuel dickson philip 
Designation  Post graduate student (MPT) 
Affiliation  Father muller medical college 
Address  Department of physiotherapy Father muller medical college Mangalore
Department of physiotherapy Father muller medical college Mangalore

KARNATAKA
575002
India 
Phone  7406145972  
Fax    
Email  dcksnphilp@gmail.com  
 
Source of Monetary or Material Support  
Samuel dickson philip Department of physiotherapy father muller medical college,Mangalore-575002 
 
Primary Sponsor  
Name  Samuel dickson philip 
Address  Department of physiotherapy Father Muller Medical college Mangalore-575002 
Type of Sponsor  Other [self sponsored ] 
 
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 
Samuel Dickson Philip  Father Muller Medical College   Department of Physiotherapy Father Muller Medical College Mangalore-575002
Dakshina Kannada
KARNATAKA 
7406145972

dcksnphilp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Frozen Shoulder Subjects,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Capsular stretching  capsular stretching in four different directions(Passive forward elevation,external rotation,Horizontal Adduction and Internal rotation for 10 to 15 seconds with in pain limits for 10-15 repitions for twice a day for ten days in two weeks 
Intervention  Proprioceptive neuromuscular facilitation stretching   D2 proprioceptive neuromuscular facilitation stretching will be given in flexion and extension pattern .The stretch will be given for 8 repitions per set consisting of 2 sets per session with one single session per dayfor 10 days in two weeks with each stretch maintained for almost 10-15 seconds 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Unilateral frozen shoulder ,Frozen shoulder individuals with limited range of motioncfor shoulder abduction, external rotation and flexion 
 
ExclusionCriteria 
Details  Any recent shoulder surgery,Rheumatoid arthritis,Any recent history for fracture around shoulder complex,Subjects with rotator cuff tear 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
universal goniometer,
Shoulder pain and disability index 
Difference in Range of motion and functional activities after two weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Visual analogue scale
 
Difference in pain after two weeks of intervention 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   12/04/2017 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

TITLE OF THE TOPIC : COMPARITIVE EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION STRETCHING AND CAPSULAR STRETCHING ON RANGE OF MOTION AND FUNCTIONAL ACTIVITES IN FROZEN SHOULDER

                   

                        Frozen shoulder, or adhesive capsulitis, describes the common shoulder condition characterized by painful and limited active and passive range of motion (ROM). Frozen shoulder is reported to affect 2% to 5% of the general population increasing to 10% to 38% in patients with diabetes and thyroid disease. Individuals with primary frozen shoulder are commonly between 40 and 65 years old, and the incidence appears higher in females than males.The occurrence of frozen shoulder in 1 shoulder increases the risk of contralateral shoulder involvement by 5% to 34%, and simultaneous bilateral shoulder involvement occurs as often as 14% of the time. Based on the etiology adhesive capsulitis can be classified as primary or secondary. Primary adhesive capsulitis is an idiopathic condition, where the exact underlying cause is unknown. Adhesive capsulitis associated with a known underlying disorder is considered to be secondary. adhesive capsulitis is described  in four stages, Stage I: Preadhesive stage in which lining of the joint (synovium) is inflamed depicts little or no restriction of glenohumeral motion, Stage II (Freezing stage): Acute adhesive synovitis with proliferative synovitis and scar formation of the underlying capsule, Stage III (Frozen stage): Marked stiffness due to scar formation in the capsule with loss of axillary fold, Stage IV (Thawing stage): Chronic stage presenting with fully mature adhesions with notable restriction of ROM. In Stages II and III of frozen shoulder, ROM is significantly restricted. Restriction of movement is in the capsular pattern, that is, external rotation is most limited, followed by limitation in abduction and internal rotation respectively.


Research question:

                        Is there a significant difference in the effectiveness between proprioceptive neuromuscular facilitation stretching and capsular stretching in improving the Range of motion and functional activities in individulas with frozen shoulder?

 

Hypothesis:

           Null hypothesis:

                 There is no significant difference in the effectiveness between proprioceptive neuromuscular facilitation stretching and capsular stretching in improving the Range of motion and functional activities in individuals with frozen shoulder.

            

           Alternate hypothesis:

                  There is significant difference in the effectiveness between proprioceptive neuromuscular facilitation stretching and capsular stretching in improving the Range of motion and functional activities in individuals with frozen shoulder.



OBJECTIVE OF THE STUDY: To compare the effectiveness between proprioceptive neuromuscular facilitation  stretching and capsular stretching in improving the Range of motion and functional activities in frozen shoulder.

         

 

 

 

 



PROCEDURE: The subjects falling within the inclusion criteria will be included in the study and then they will be randomly assigned into two groups. Three outcome measures will be taken for the individuals that is both pre and post treatment outcome measures by using goniometry for range of motion, visual analogue scale for pain and shoulder pain and disability index for functional limitation.

 GROUP-A:- The individuals in Group –A will be receiving first moist heat therapy  for  10 to 20 minutess followed by proprioceptive neuromuscular facilitation stretching in supine lying to improve flexion, abduction and external rotation of the glenohumeral joint in D2 proprioceptive neuromuscular facilitation stretching in Flexion and Extension pattern. The stretch will be given for 8 repetitions per set consisting of 2 sets per session with one single session per day for 10 days in two weeks with each repetition or stretch maintained for  a duration of 5–10 seconds. This will be followed by Active assisted range of motion exercises, Pendulum exercises and Finger ladder exercises.

GROUP-B:- The individuals in Group­-B will also be receiving first the moist heat therapy for 10 to 20 minutes followed by capsular stretching in four directions (Passive forward elevation, external rotation, Horizontal adduction and internal rotation) the stretching will be maintained for 10 seconds within pain limits, with 10–15 repetitions. The sets of exercises should be performed twice a day for ten days in two weeks. This will be followed by Active assisted range of motion exercises, Pendulum exercises and Finger ladder exercises.

 

 
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