Dynamic Splinting for Patients With Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

— DS-SDH  

Official title:

Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00873158
• Other study ID #: Shoulder 100
• Status: Terminated
• Phase: N/A
• First received: March 31, 2009
• Last updated: August 8, 2013
• Start date: January 2006

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two treatments for adhesive capsulitis.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group 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

Locations

Country	Name	City	State
United States	Andrews Research & Education Institute	Gulf Breeze	Florida
United States	Gaspar Physical Therapy	Solana Beach	California
United States	University Orthopedics Center	State College	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.	McMurry University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Carette S, Moffet H, Tardif J, Bessette L, Morin F, Frémont 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. — View Citation

Hamdan TA, Al-Essa KA. Manipulation under anaesthesia for the treatment of frozen shoulder. Int Orthop. 2003;27(2):107-9. Epub 2002 Sep 13. — View Citation

Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109. Review. — 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

Hsu AT, Ho L, Ho S, Hedman T. Immediate response of glenohumeral abduction range of motion to a caudally directed translational mobilization: a fresh cadaver simulation. Arch Phys Med Rehabil. 2000 Nov;81(11):1511-6. — View 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. — View Citation

Kirkley A, Griffin S, Dainty K. Scoring systems for the functional assessment of the shoulder. Arthroscopy. 2003 Dec;19(10):1109-20. Review. — View 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. — View Citation

Othman A, Taylor G. Manipulation under anaesthesia for frozen shoulder. Int Orthop. 2002;26(5):268-70. Epub 2002 Mar 27. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of physical therapy treatments required		throughout trial	No
Primary	Weeks of Dynasplint treatment		throughout trial	No
Secondary	Shoulder Range Of Motion		initial consultation, first visit following injection, and monthly following injection	No
Secondary	Sharp FAS Neck and Shoulder		initial consultation, immediatly prior to first treatment following injection, and monthly following injection	No
Secondary	Disabilities of Arm, Hand, and Shoulder Questionnaire		initial visit, first visit following injection, and weekly until discharge	No