Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202963
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-02
Brief Title:
Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation
Sponsor:
Haydarpasa Numune Training and Research Hospital
Organization:
Haydarpasa Numune Training and Research Hospital
Study Overview
Official Title:
Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation
Detailed Description:
This study is organised as double-blind randomised controlled trial Written informed consent will be taken from all the patients participating to the study
Inclusion Criteria
Patients between the ages of 30 and 70 who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination will be included in the study
Exlusion Criteria
1 A history of physical therapy or injections for the shoulder joint within the previous three months
2 The existence of a neurological condition or surgical history that could impair upper limb functions
3 Being a breastfeeding or pregnant woman
4 Mental illnesses and cognitive impairments that impair cooperation
5 Diabetes mellitus with unregulated glucose levels
6 Presenece of Cancer
Patients included in the study will be divided into two groups by block randomization
In group 1 hydrodilatation will be performed with intra-articular 40 mg triamcinolone lidocaine and physiological saline through a posterior approach to the shoulder guided by ultrasonographic imaging Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography The amount of fluid given will be recorded
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone lidocaine and physiological saline through a posterior approach to the shoulder guided by ultrasonographic imaging Additionally with ultrasonographic evaluation 2 cc of physiological saline will be injected into the corocohumeral ligament
All the patients will be evaluated by a doctor who is blind to the study groups Demographic information history of shoulder pain presence of chronic diseases pain severity measured by VAS during restingactivity and sleep will be recorded Physical examination including shoulder range of motion will be evaluated Shoulder Disability Index will be used for evaluating the functional status of shoulder They will be evaluated before and immediately after injection 1 week later 1 month and 2 months after injection with VAS shoulder range of motion and Shoulder Disability Index
Inclusion Criteria
Patients between the ages of 30 and 70 who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination will be included in the study
Exlusion Criteria
1 A history of physical therapy or injections for the shoulder joint within the previous three months
2 The existence of a neurological condition or surgical history that could impair upper limb functions
3 Being a breastfeeding or pregnant woman
4 Mental illnesses and cognitive impairments that impair cooperation
5 Diabetes mellitus with unregulated glucose levels
6 Presenece of Cancer
Patients included in the study will be divided into two groups by block randomization
In group 1 hydrodilatation will be performed with intra-articular 40 mg triamcinolone lidocaine and physiological saline through a posterior approach to the shoulder guided by ultrasonographic imaging Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography The amount of fluid given will be recorded
The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone lidocaine and physiological saline through a posterior approach to the shoulder guided by ultrasonographic imaging Additionally with ultrasonographic evaluation 2 cc of physiological saline will be injected into the corocohumeral ligament
All the patients will be evaluated by a doctor who is blind to the study groups Demographic information history of shoulder pain presence of chronic diseases pain severity measured by VAS during restingactivity and sleep will be recorded Physical examination including shoulder range of motion will be evaluated Shoulder Disability Index will be used for evaluating the functional status of shoulder They will be evaluated before and immediately after injection 1 week later 1 month and 2 months after injection with VAS shoulder range of motion and Shoulder Disability Index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None