- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06613594
Effects of Kaltenborn Translatoric Glides As Compared to Traction Mobilization in the Management of Frozen Shoulder
Study Overview
Status
Conditions
Detailed Description
Frozen shoulder is a common MSK condition with an insidious onset accompanied by stiffness and trouble sleeping on the affected side.This condition effects General population 2-5% globally, diabetics 10-20%. Women have a significantly higher incidence males 70% of cases are female.frozen shoulder is a painful, gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.
The capsule in frozen shoulder tightens,thickness and adheres to bone it causes severe limiting of both osteikinetics and arthrokinetics shoulder range of motion,resulting in long term functional disability.As the capsule thickens mobility limitations occurs in capsular pattern.Kalternborn traction mobilization helpful in breaking capsular adhesions and decreasein severe pain, Improving shoulder limitation such as external roation ,abduction and internal rotation kaltnborn translatoric glides effective.
These mobilization changes the relative capsular adhesions and reduce stress on Gleno-humeral joint.
In clinically both techniques of kaltnborn joint mobilization are used but there is no evidence which one is more effective in the management of frozen shoulder.
Hence the current study will investigate the effects of Kaltenborn linear tranlatoric glides as compared to traction mobilization mobilization on shoulder range of motion and pain in patients with adhesive capsulitis.
This study includes Subjects with nonspecific adhesive capsulitis without specific identifiable etiology (i.e. infection, inflammatory disease) ,40-65 years of age both males and females and chronic shoulder pain > 3 months,positive capsular pattern.The selection of subjects will be using non-probability purposive sampling technique.Participants will be randomized using sealed envelope method and allocated to one of the 3 groups.
The data collection tools for pain is VAS, for ROM goniometer is used , for FEAR used fear avoidance belief questionnaire and for functional disablity is SPADI.
The time duration for treatment protocol is total of 10 sessions, 5 sessions per week for 2 consecutive weeks for approximately 25-30 mins.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Afifa Zuha, MS-MSKPT*
- Phone Number: +92334948496
- Email: Afifabhattis123@gmail.com
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- muhammad Osama, PhD
- Phone Number: +92332550436
- Email: osama@fui.edu.pk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with Nonspecific frozen shoulder without specific identifiable etiology (i.e. infection, inflammatory disease)
- 40-65 years of age both males and females.
- Chronic shoulder pain > 3 months.
- Positive capsular pattern.
Exclusion Criteria:
- Patients with other shoulder joint pathologies, such as fractures or dislocations, glenohumeral instability or rotator cuff pathologies in the affected shoulder.
- Subjects who have undergone surgery or have experienced an acute trauma to the shoulder.
- Individuals with current or history of neurological disorders (such as stroke, Alzheimer's, or Parkinson's), rheumatologic diseases (such as rheumatoid arthritis or systemic lupus erythematous), or systemic illnesses (such as thyroid disease).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physical Therapy Group
Patients in this group will recieve conventional physical therapy including Hot pack and Tens for 10 to 15 minutes.Broomstick ROM exercises such as Internal & external rotation,Extension,flexion,abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day, pain free passive, 3 sets of 10 reps with 1 minute rest in between will be given, Codman circular motion exercises(1time clockwise ,1 time anticlcock wise) 2-3 times/day with 10reps .Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 weeks.
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Patients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises.
A total of 10 sessions, 5 sessions per week for 2 consecutive weeks.
|
|
Experimental: Conventional physical therapy+kaltenborn traction Group
Patients will recieve kaltenborn traction mobiliztion in addition to conventional physical therapy including Hot pack and tens for 10 to 15 minutes , Broomstick ROM exercises such as Flexion, Internal & external rotation,Extension, Abduction,these are Low intensity, short duration, 1-5 sec, 2-3 times/day with 10 reps, pain free passive, AAROM.Codman circular motion exercises (1time clockwise ,1 time anticlockwise) 2-3 times/day with 10 reps.
kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given.
Strengthening exercises include Isometric in all planes, 5 second holds, 1 set of 10 each direction, against wall.Every session will be given for 30 minutes and a total of 10 sessions would be conducted over a period of 2 consecutive weeks.
|
Patients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises.
A total of 10 sessions, 5 sessions per week for 2 consecutive weeks.
kaltenborn direction non specific traction mobilization for (1 minute), 3 sets of 10 reps with 1 minute rest in between will be given.
|
|
Experimental: Conventional physical therapy+kaltenborn translatoric glides Group
Patient will recieve kaltnborn linear translatoric glides in addittion to Conventional physical therpay including Hot packs and tens for 10-15 minutes.
Broomstick ROM exercises such as flexion,Exention,Internal rotation,External roation and Abuction,these are low intensity,short duration,1- 5sec,2-3 times/ day with10 reps,pain free passive, AAROM.Codman exercises circular motion exercises (1time clock wise ,1Time anticlockwise), 2-3 times/day with 10reps.
Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide,such anterior glide for extension and external rotation,caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will perfromed with 10 reps,rest of 1 minutes between these sets.
Strengthening exercises including Isometric in all planes,5sec hold,1 sets of 10 each direction against wall.
Every session will be given for 30 minutes and a total of 10 session would be conduted over a period of 2 weeks.
|
Patients will receive hot pack, Broom stick ROM exercises, Codman and strengthening exercises.
A total of 10 sessions, 5 sessions per week for 2 consecutive weeks.
Kaltenborn direction specific linear tranlatoric glides, rhtymic 5reps of each glide, such anterior glide for extension and external rotation, caudal glide for abduction,post glide for flexion and internal roation,these3 sets of painless glides will performed with 10 reps,rest of 1 minutes between these sets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear Avoidance belief
Time Frame: 2 weeks
|
fear of pain to do movement will be assessed by using fear avoidance belief questionnaire .
|
2 weeks
|
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Pain Intensity
Time Frame: 2 weeks
|
Pain will be assessed using Visual Analog scale which is 0-100 item scale.
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2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Range of motion
Time Frame: 2 weeks
|
Range of motion will be assessed using universal goniometer.
|
2 weeks
|
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Shoulder Disability
Time Frame: 2 weeks
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Shoulder Disability will be assessed using shoulder pain and disability index.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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