Adhesive Capsulitis and Dynamic Splinting

Adhesive Capsulitis Clinical Trial

Official title:

Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01874821
• Other study ID #: 2010.005
• Secondary ID: SHD
• Status: Terminated
• Phase: N/A
• First received: June 7, 2013
• Last updated: August 8, 2013
• Start date: January 2013

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Periarthritis

Intervention

Device:
• Dynasplint
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen

Other:
• Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Epub 2006 Oct 10. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).	6 months	No