Clinical trial NCT01874821: Adhesive Capsulitis and Dynamic Splinting
Official title: Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Frozen Shoulder
Adhesive Capsulitis
ROM
Dynasplint
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of dynamic splinting in reducing contracture following diagnosis of adhesive capsulitis.

Detailed description: This randomized controlled trial will explore the efficacy of dynamic splinting in conjunction with the current standard of care as compared to standard of care alone.

Eligibility criteria: Inclusion Criteria:

* Greater than 25% reduction in maximal external rotation plus greater than 25% reduction in at least one other plane of motion (elevation or abduction), as compared to the asymptomatic shoulder, measure supine with humerus abducted to 90º
* Duration from onset less than 12 months.
* Pain that is worsened by moving the arm in that direction

Exclusion Criteria:

* Any previous shoulder surgery.
* Brachial plexus injuries
* Neurologically mediated pain and fibromatosis-like contracture
* Concomitant neurologic complaints or abnormalities
* Glenohumeral impingement or mechanical blockage
* Oncological process affecting the shoulder
* Previous total mastectomy
* Glenohumeral arthritis

Primary outcomes:
measure: Efficacy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
citation: Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10.
citation: Castellarin G, Ricci M, Vedovi E, Vecchini E, Sembenini P, Marangon A, Vangelista A. Manipulation and arthroscopy under general anesthesia and early rehabilitative treatment for frozen shoulders. Arch Phys Med Rehabil. 2004 Aug;85(8):1236-40. doi: 10.1016/j.apmr.2003.12.032.
citation: Farrell CM, Sperling JW, Cofield RH. Manipulation for frozen shoulder: long-term results. J Shoulder Elbow Surg. 2005 Sep-Oct;14(5):480-4. doi: 10.1016/j.jse.2005.02.012.
citation: Hsu AT, Hedman T, Chang JH, Vo C, Ho L, Ho S, Chang GL. Changes in abduction and rotation range of motion in response to simulated dorsal and ventral translational mobilization of the glenohumeral joint. Phys Ther. 2002 Jun;82(6):544-56.
citation: Rundquist PJ, Anderson DD, Guanche CA, Ludewig PM. Shoulder kinematics in subjects with frozen shoulder. Arch Phys Med Rehabil. 2003 Oct;84(10):1473-9. doi: 10.1016/s0003-9993(03)00359-9.
citation: Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68.