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CTRI Number  CTRI/2024/09/074170 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 19/08/2025
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   A study to find out if PNF stretching or Kaltenborn mobilization helps reduce pain and improve movement in people with frozen shoulder.  
Scientific Title of Study   A comparative study of PNF(Proprioceptive neuromuscular facilitation) stretch vs kaltenborn mobilization technique on pain and disability in patients with adhesive capsulitis-A randomized control trail 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandini A H 
Designation  PG student  
Affiliation  Narayana hrudayalaya institute of physiotherapy  
Address  258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya international wing physiotherapy center,room no.102
258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya international wing physiotherapy center,room no.102
Bangalore
KARNATAKA
560099
India 
Phone  6363669238  
Fax    
Email  nandinihiregouda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Smruti swagatika dash  
Designation  Professor 
Affiliation  Narayana hrudayalaya institute of physiotherapy 
Address  258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya institute of physiotherapy
258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya institute of physiotherapy
Bangalore
KARNATAKA
560099
India 
Phone  9448552026  
Fax    
Email  ssdashpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nandini A H 
Designation  PG student 
Affiliation  Narayana hrudayalaya institution of physiotherapy 
Address  258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya inetnational wing physiotherapy center,room no.102
258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Narayana hrudayalaya international wing physiotherapy center,room no.102
Bangalore
KARNATAKA
560099
India 
Phone  6363669238  
Fax    
Email  nandinihiregouda@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy OPD-Narayana hrudayalaya international wing physiotherapy center,room no.102 258/A,Health city, Bommasndra, industrial area, Anekal taluk,Bangalore-560099 Karnataka,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 
DrNandini A H  Narayana hrudayala institution of physiotherapy   Narayana hrudayalaya international wing physiotherapy center,room no.102 258/A,Health city,Bommasandra industrial area, Anekal taluk. Bangalore - 560099
Bangalore
KARNATAKA 		 6363669238

nandinihiregouda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana hrudayalaya academic ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M729||Fibroblastic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kaltenborn Mobilization  This group will undergo Kaltenborn Mobilization with conventional therapy (standard protocol of adhesive capsulitis). The mobilization glides that will be given are caudal, and ventral glides. The glides will be given at a rate of 5 sets of 6 to 10 repetitions thrice a week for 4 weeks. The Pain, and SPADI these outcome measures that will be assessed pre- and post-intervention.  
Intervention  PNF Stretching  This group will undergo Proprioceptive Neuromuscular Facilitation (PNF) Stretch: Administered in a diagonal (D2) flexion and extension pattern for 5 repetitions per set, 2 sets per session, 1 session per day, 3 days per week for 1 month. The Pain, and SPADI these outcome measures that will be will be assessed pre- and post-intervention 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Unilateral limb involvement
Subjects with second and third stage of adhesive capsulitis
 
 
ExclusionCriteria 
Details  Subjects with post traumatic immobilization
Subjects with cognitive impairment
Subjects with previous surgery /arthroscopy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NPRS (Numerical pain rating scale)   After the 4 weeks of intervention application  
 
Secondary Outcome  
Outcome  TimePoints 
SPADI(Shoulder Pain And Disability Index)  After the 4 weeks of intervention application  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   04/10/2024 
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="0"
Months="6"
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  

AIMS

To find out the effectiveness of proprioceptive neuromuscular facilitation Stretch in comparison with kaltenborn mobilization on pain and disability in patients with adhesive capsulitis.

 

 

PRIMARY OBJECTIVE

·        To compare the effects of  proprioceptive neuromuscular facilitation Stretch and kaltenborn mobilization technique in patients with adhesive capsulitis.

 

 

SECONDARY OBJECTIVE

·       1. To compare the effects of proprioceptive neuromuscular facilitation stretching and kaltenborn mobilization technique in patients with adhesive capsulitis.

·    2.Evaluate proprioceptive neuromuscular facilitation stretching and kaltenborn mobilization technique effectively reduces pain among patients with adhesive capsulitis.

·        3.To assess proprioceptive neuromuscular facilitation stretching and kaltenborn mobilization technique are effective in improving shoulder function among patients with adhesive capsulitis.


Hypothesis

 

Null Hypothesis

 1.There will be no significant effect of proprioceptive neuromuscular facilitation stretch on pain and disability in patients with

adhesive capsulitis.

2.There will be no significant effect of kaltenborn mobilization technique on pain and disability in patients with adhesive capsulitis.

3. There will be no significant difference of proprioceptive neuromuscular facilitation stretch compared to kaltenborn mobilization technique on pain and disability in patients with adhesive capsulitis.

 

 

Alternate Hypothesis 

 1.There will be significant effect of proprioceptive neuromuscular facilitation stretch on pain and disability in patients with

adhesive capsulitis.

2.There will be significant effect of kaltenborn mobilization technique on pain and disability in patients with adhesive capsulitis.

3. There will be significant difference of proprioceptive neuromuscular facilitation stretch compared to kaltenborn mobilization technique on pain and disability in patients with adhesive capsulitis.

 

 
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