| 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 |
|
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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] |
|
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Details of Secondary Sponsor
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| •Shoulder pain and disability index scale (SPADI) |
pre intervention and post intervention |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| passive range of motion of shoulder flexion, abduction, internal rotation and external rotation |
pre intervention and post intervention |
|
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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)?
|
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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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