Trials / Withdrawn
WithdrawnNCT00742846
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lidocaine + Kenalog | 5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid |
| DRUG | Lidocaine + Kenalog | 5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space Local anesthetic and steroid in to the subacromial space |
| DRUG | Lidocaine | 5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection |
| DRUG | Lidocaine | 5ml 1% Lidocaine alone into the subacromial space. subacromial local anesthetic injection |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-08-28
- Last updated
- 2015-02-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00742846. Inclusion in this directory is not an endorsement.