Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dynasplint
Along with standard manual physical therapy, patients will have a stretching device (Dynasplint) used in rehabilitation to regain ROM in stiff joints. Patients will use this device 20-30 minutes 2 times per day at home.
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
Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
Control
Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
Interventions
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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
Standard of Care
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration from onset less than 12 months.
* Pain that is worsened by moving the arm in that direction
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dynasplint Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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New York University
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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SHD
Identifier Type: OTHER
Identifier Source: secondary_id
2010.005
Identifier Type: -
Identifier Source: org_study_id