Frozen Shoulder
Conditions
Brief summary
In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.
Detailed description
Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition. It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months
Interventions
PROCEDUREInterscalene block with nerve catheter
Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours
Sponsors
OAD Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis * Failed conservative treatment for a minimum of 4 months * Patient had 3 sequential office visits with no clinical improvement
Exclusion criteria
* Adhesive capsulitis following a surgical procedure and/or fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in shoulder function as demonstrated by increased range of motion | 10 days, 4, 8, 16 weeks and 6 months | The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in shoulder pain | 10 days, 4, 8, 16 weeks and 6 months | The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score. |
Countries
United States
Contacts
Primary ContactMarjorie Delaney, APN
Outcome results
None listed