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Adhesive Capsulitis and Dynamic Splinting

Primary Purpose

Adhesive Capsulitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynasplint
Standard of Care
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dynasplint

Control

Arm Description

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.

Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention

Outcomes

Primary Outcome Measures

Efficacy
The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).

Secondary Outcome Measures

Full Information

First Posted
June 7, 2013
Last Updated
August 8, 2013
Sponsor
Dynasplint Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01874821
Brief Title
Adhesive Capsulitis and Dynamic Splinting
Official Title
Adhesive Capsulitis and Dynamic Splinting: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Unrelated to trial
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Frozen Shoulder, Adhesive Capsulitis, ROM, Dynasplint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynasplint
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Patient's in the Physical Therapy Group will have the standard manual treatments during their usual physical therapy visits with no additional intervention
Intervention Type
Device
Intervention Name(s)
Dynasplint
Other Intervention Name(s)
Shoulder
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
Primary Outcome Measure Information:
Title
Efficacy
Description
The primary measures are full arc ROM and changes in the Disabilities of the Arm Shoulder Hand pain survey (DASH).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17031613
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. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687.
Results Reference
background
PubMed Identifier
15295746
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.
Results Reference
background
PubMed Identifier
16194738
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.
Results Reference
background
PubMed Identifier
12036396
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.
Results Reference
background
PubMed Identifier
14586914
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.
Results Reference
background
PubMed Identifier
16506872
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.
Results Reference
background

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Adhesive Capsulitis and Dynamic Splinting

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