Dynamic Splinting for Patients With Adhesive Capsulitis (DS-SDH)
Primary Purpose
Adhesive Capsulitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynasplint
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, ROM, Dynasplint
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic adhesive capsulitis
- greater than 50% limitation in active flexion, internal rotation, or external rotation
- Tight GHJ capsule in at least 2 directions
- Capsular end-feel primarily limits ROM
- Age 40- 64
- Normal X-Rays
Exclusion Criteria:
- Acute adhesive capsulitis
- History of Diabetes Mellitus
- Evidence of a cuff tear
- Recent history of trauma
- Evidence of glenohumeral DJD
- History of shoulder surgery
- Calcification of tendonitis demonstrated on a current X-Ray
- Abnormal X-Ray
- Cervical Radiculopathy/brachial plexus lesions
- Less than 2+/5 muscle strength during mid-line manual muscle testing
- Muscle Atrophy
- Presence of associated systematic conditions
- History of prior therapy for current condition
- Manipulation under anesthesia
- Non compliance
- Shoulder-Hand syndrome, Complex Regional Pain Syndrome
- History of prior injections for the current problem
- Patient receiving worker's compensation
- Shoulder symptoms with cervical provocative testing
- Positive X-ray findings in the acromioclavicular or sternoclavicular joints
- Abnormal physical signs or symptoms in the A-C or S-C joint
Sites / Locations
- Gaspar Physical Therapy
- Andrews Research & Education Institute
- University Orthopedics Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Physical Therapy Group
Dynasplint Group
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
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.
Outcomes
Primary Outcome Measures
Number of physical therapy treatments required
Weeks of Dynasplint treatment
Secondary Outcome Measures
Shoulder Range Of Motion
Sharp FAS Neck and Shoulder
Disabilities of Arm, Hand, and Shoulder Questionnaire
Full Information
NCT ID
NCT00873158
First Posted
March 31, 2009
Last Updated
August 8, 2013
Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University
1. Study Identification
Unique Protocol Identification Number
NCT00873158
Brief Title
Dynamic Splinting for Patients With Adhesive Capsulitis
Acronym
DS-SDH
Official Title
Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Unrelated to trial
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.
Collaborators
McMurry University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare two treatments for adhesive capsulitis.
Detailed Description
The purpose of this study is to examine the effects of two treatment regimens for adhesive capsulitis: dynamic splinting and/or manual physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, ROM, Dynasplint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy Group
Arm Type
No Intervention
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
Arm Title
Dynasplint Group
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.
Intervention Type
Device
Intervention Name(s)
Dynasplint
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
Primary Outcome Measure Information:
Title
Number of physical therapy treatments required
Time Frame
throughout trial
Title
Weeks of Dynasplint treatment
Time Frame
throughout trial
Secondary Outcome Measure Information:
Title
Shoulder Range Of Motion
Time Frame
initial consultation, first visit following injection, and monthly following injection
Title
Sharp FAS Neck and Shoulder
Time Frame
initial consultation, immediatly prior to first treatment following injection, and monthly following injection
Title
Disabilities of Arm, Hand, and Shoulder Questionnaire
Time Frame
initial visit, first visit following injection, and weekly until discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic adhesive capsulitis
greater than 50% limitation in active flexion, internal rotation, or external rotation
Tight GHJ capsule in at least 2 directions
Capsular end-feel primarily limits ROM
Age 40- 64
Normal X-Rays
Exclusion Criteria:
Acute adhesive capsulitis
History of Diabetes Mellitus
Evidence of a cuff tear
Recent history of trauma
Evidence of glenohumeral DJD
History of shoulder surgery
Calcification of tendonitis demonstrated on a current X-Ray
Abnormal X-Ray
Cervical Radiculopathy/brachial plexus lesions
Less than 2+/5 muscle strength during mid-line manual muscle testing
Muscle Atrophy
Presence of associated systematic conditions
History of prior therapy for current condition
Manipulation under anesthesia
Non compliance
Shoulder-Hand syndrome, Complex Regional Pain Syndrome
History of prior injections for the current problem
Patient receiving worker's compensation
Shoulder symptoms with cervical provocative testing
Positive X-ray findings in the acromioclavicular or sternoclavicular joints
Abnormal physical signs or symptoms in the A-C or S-C joint
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buck Willis, PhD
Organizational Affiliation
Dynasplint Systems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Gaspar Physical Therapy
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
Facility Name
Andrews Research & Education Institute
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12700935
Citation
Hamdan TA, Al-Essa KA. Manipulation under anaesthesia for the treatment of frozen shoulder. Int Orthop. 2003;27(2):107-9. doi: 10.1007/s00264-002-0397-6. Epub 2002 Sep 13.
Results Reference
background
PubMed Identifier
12378350
Citation
Othman A, Taylor G. Manipulation under anaesthesia for frozen shoulder. Int Orthop. 2002;26(5):268-70. doi: 10.1007/s00264-002-0348-2. Epub 2002 Mar 27.
Results Reference
background
PubMed Identifier
9917683
Citation
Placzek JD, Roubal PJ, Freeman DC, Kulig K, Nasser S, Pagett BT. Long-term effectiveness of translational manipulation for adhesive capsulitis. Clin Orthop Relat Res. 1998 Nov;(356):181-91. doi: 10.1097/00003086-199811000-00025.
Results Reference
background
PubMed Identifier
11517365
Citation
Omari A, Bunker TD. Open surgical release for frozen shoulder: surgical findings and results of the release. J Shoulder Elbow Surg. 2001 Jul-Aug;10(4):353-7. doi: 10.1067/mse.2001.115986.
Results Reference
background
PubMed Identifier
8020231
Citation
Pollock RG, Duralde XA, Flatow EL, Bigliani LU. The use of arthroscopy in the treatment of resistant frozen shoulder. Clin Orthop Relat Res. 1994 Jul;(304):30-6.
Results Reference
background
PubMed Identifier
8986657
Citation
Warner JJ, Allen A, Marks PH, Wong P. Arthroscopic release for chronic, refractory adhesive capsulitis of the shoulder. J Bone Joint Surg Am. 1996 Dec;78(12):1808-16. doi: 10.2106/00004623-199612000-00003.
Results Reference
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PubMed Identifier
12632439
Citation
Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.
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PubMed Identifier
11678298
Citation
Arslan S, Celiker R. Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis. Rheumatol Int. 2001 Sep;21(1):20-3. doi: 10.1007/s002960100127.
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PubMed Identifier
10738419
Citation
Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
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PubMed Identifier
11087307
Citation
Vermeulen HM, Obermann WR, Burger BJ, Kok GJ, Rozing PM, van Den Ende CH. End-range mobilization techniques in adhesive capsulitis of the shoulder joint: A multiple-subject case report. Phys Ther. 2000 Dec;80(12):1204-13.
Results Reference
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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.
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PubMed Identifier
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Citation
Hsu AT, Ho L, Ho S, Hedman T. Joint position during anterior-posterior glide mobilization: its effect on glenohumeral abduction range of motion. Arch Phys Med Rehabil. 2000 Feb;81(2):210-4. doi: 10.1016/s0003-9993(00)90143-6.
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Citation
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Citation
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Results Reference
derived
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Dynamic Splinting for Patients With Adhesive Capsulitis
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