Adhesive Capsulitis
Conditions
Keywords
Adhesive Capsulitis, Subacromial injection, Intraarticular injection
Brief summary
The primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid injections. The secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.
Detailed description
Current treatment for Adhesive Capsulitis involves physical therapy. Steroid injections have not been shown to be as effective alone without the physical therapy. However, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. After a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. There are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. This study would help us determine if location of the injection is a major factor in regaining motion. If it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.
Interventions
DRUGLidocaine + Kenalog
5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid
DRUGLidocaine
5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Meet clinical diagnosis of primary Adhesive Capsulitis * Restriction in abduction to less than 130 degrees * 50% reduction in external rotation as compared with the contralateral side * An intact rotator cuff * Between 18-75 years of age
Exclusion criteria
* Previous shoulder capsular surgery * History of steroid injection(s) into affected shoulder * Inability to provide informed consent * Iodinated contrast dye allergy * Allergy to lidocaine * Other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis) * Known bleeding diathesis * Cervical spine pathology * History of trauma to the shoulder * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of this study is to document the return of shoulder motion and resolution of adhesive capsulitis after intra-articular versus subacromial steroid injections versus anesthetic injections in combination with physical therapy. | 6-8 months |
Countries
United States
Outcome results
None listed