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CTRI Number  CTRI/2019/07/020106 [Registered on: 09/07/2019] Trial Registered Prospectively
Last Modified On: 20/10/2020
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 CHECK THE EFFECTIVENESS OF TWO DIFFERENT JOINT MOVEMENT TECHNIQUES IN 40-65 YEAR OLD PATIENTS WITH SHOULDER STIFFNESS 
Scientific Title of Study   EFFECTIVENESS OF END RANGE MOBILIZATION AND REVERSE DISTRACTION TECHNIQUE IN ADHESIVE CAPSULITIS - A COMPARATIVE STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  J Elisha  
Designation  Post Graduate student  
Affiliation  SDM College of Physiotherapy, Manjushree nagar, Sattur  
Address  SDM College of Medical Sciences and Hospital, Manjushree nagar, Sattur, SDM College of Physiotherapy, Manjushree nagar, Sattur, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8217753779  
Fax  08362462253  
Email  elishjeedi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev K Lal 
Designation  Professor and PG guide  
Affiliation  SDM College of Physiotherapy, Manjushree nagar, Sattur  
Address  SDM College of Medical Sciences and Hospital, Manjushree nagar, Sattur, SDM College of Physiotherapy, Manjushree nagar, Sattur, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  7483324010  
Fax  08362462253  
Email  lalrk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev K Lal 
Designation  Professor and PG guide  
Affiliation  SDM College of Physiotherapy, Manjushree nagar, Sattur  
Address  SDM College of Medical Sciences and Hospital, Manjushree nagar, Sattur, SDM College of Physiotherapy, Manjushree nagar, Sattur, Dharwad


KARNATAKA
580009
India 
Phone  7483324010  
Fax  08362462253  
Email  lalrk@yahoo.com  
 
Source of Monetary or Material Support  
SDM College Of Physiotherapy Manjushree nagar sattur dharwad 
 
Primary Sponsor  
Name  J Elisha 
Address  SDM College Of Physiotherapy Manjushree nagar sattur dharwad 
Type of Sponsor  Other [self] 
 
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 
J Elisha  SDM college of medical sciences and hospital  orthopaedic physiotherapy department opd number 5, old building, SDM college of medical sciences and hospital Manjushree nagar, sattur Dharwad KARNATAKA
Dharwad
KARNATAKA 
8217753779

elishjeedi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Permision  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group A   end range mobilization along with conventional therapy 3 days a week for 4 weeks 
Comparator Agent  group B  reverse distraction technique along with conventional therapy 3 days a week for 4 weeks  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Subjects of age group between 40 to 65 years.
2)Both the genders.
3)Subjects who have limited ROM of a unilateral shoulder joint(ROM losses of 50% or greater compared with the uninvolved shoulder in the following shoulder motions:flexion, abduction, lateral rotation and medial rotation) for atleast 3 months.
 
 
ExclusionCriteria 
Details  1)Subjects less than 40 years and above 65 years of the age.

2)Malunited fracture around shoulder complex.

3)Rotator cuff tear.

4)Neurological conditions leading to muscular imbalances.

5)Cardiac disease and cardiac surgery.

6)Recent surgery around shoulder complex.

7)Unstable shoulder / recurrent dislocation.

8)Malignancies in and around shoulder.

9)Other form of arthritis like rheumatoid or infective of the shoulder.

10)Osteoporosis.

11)Subjects not willing to participate.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
•Shoulder pain and disability index scale (SPADI)  pre intervention and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
passive range of motion of shoulder flexion, abduction, internal rotation and external rotation  pre intervention and post intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/07/2019 
Date of Study Completion (India) 29/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
not yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Adhesive capsulitis is an insidious onset of painful stiffness of the glenohumeral joint. Despite the last centurial research the etiopathology of adhesive capsulitis remain enigmatic. The prevalence of adhesive capsulitis in the normal population is 2 to 5 percent and increases in patients with type 1 and type 2 diabetes. It is commonly seen between the age groups of 40 and 65 years with more occurrence in women. Most of the authors agree that the cause for adhesive capsulitis is due to the inflammatory changes in the capsule and synovium of the glenohumeral joint and therefore responsible for the contracture of the capsule.The term adhesive does not imply that the capsule is adhered to the humerus, but the humeral head is tightly held by the contracted capsule against the glenoid fossa.  There is reduction in the overall active and passive range of motion of the shoulder joint in the capsular pattern with changes observed in ROM, in ascending order, flexion, internal rotation, abduction and external rotation. The capsular extensibility is reduced and there is adherence of axillary recess. The tightness in thecapsule of the joint allows the restriction of motion in  predictable capsular pattern, capsular pattern for shoulder is one in which there is more limited external rotation than abduction. The most common functional limitations / disabilities in adhesive capsulitis often interferes with recreational activities, overhead activities, inability to reach behind head and back hence difficulty in dressing, to retrieve wallet from back pocket and sleep disturbance. Many patients complain inability to lie on the affected shoulder. Mobilization techniques are important part of intervention in many physical therapy programs. Mobilization techniques can be executed as physiological movements or accessory movements. In cardinal planes the movements of the humerus with respect to the glenohumeral joint are the physiological movements (flexion, extension, abduction, adduction, external rotation and internal rotation). The movements that occur along with the physiological movements or induced by the therapist are the accessory movements which consist of rolling, gliding, spinning and distraction within the joint. The five grade classification system of Maitland categorizes the intensity of mobilization techniques with rhythmic oscillatory movements. There are varied studies which interpret the effects of various manual therapy techniques on range of motion and functional capabilities of shoulder joint in adhesive capsulitis. Few studies conclude that the end range mobilization to be better effective than midrange mobilization,low grade mobilization technique,37 and contract relax in the intervention of adhesive capsulitis. There are also case report studies that showed improvement in glenohumeral range of motion in subjects with adhesive capsulitis. There are very limited studies which interpret the effectiveness of reverse distraction technique in subjects with  adhesive capsulitis. But there is scarcity of the literature which compared the effectiveness of end range mobilization versus the reverse distraction technique in adhesive capsulitis. Hence the study aims to know the better mobilization technique to treat the patients with adhesive capsulitis. 


































































































































 
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