Dynamic Splinting for Patients With Adhesive Capsulitis

NCT00873158 | Terminated DMC

• 1 other identifier: Shoulder 100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis; ROM; Dynasplint

Outcome Measures

Primary Outcomes (2)

• Number of physical therapy treatments required

  throughout trial

• Weeks of Dynasplint treatment

  throughout trial

Secondary Outcomes (3)

• Shoulder Range Of Motion

  initial consultation, first visit following injection, and monthly following injection

• Sharp FAS Neck and Shoulder

  initial consultation, immediatly prior to first treatment following injection, and monthly following injection

• Disabilities of Arm, Hand, and Shoulder Questionnaire

  initial visit, first visit following injection, and weekly until discharge

Study Arms (2)

Physical Therapy Group

NO INTERVENTION

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

Dynasplint Group

EXPERIMENTAL

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.

Device: Dynasplint

Interventions

Dynasplint DEVICE

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

Dynasplint Group

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead
• McMurry University: collaborator

Study Sites (3)

Gaspar Physical Therapy

Solana Beach, California, 92075, United States

Location

Andrews Research & Education Institute

Gulf Breeze, Florida, 32561, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Related Publications (15)

• 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.

  PMID: 12700935 BACKGROUND

• 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.

  PMID: 12378350 BACKGROUND

• 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.

  PMID: 9917683 BACKGROUND

• 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.

  PMID: 11517365 BACKGROUND

• 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.

  PMID: 8020231 BACKGROUND

• 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.

  PMID: 8986657 BACKGROUND

• 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.

  PMID: 12632439 BACKGROUND

• 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.

  PMID: 11678298 BACKGROUND

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

  PMID: 10738419 BACKGROUND

• 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.

  PMID: 11087307 BACKGROUND

• 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.

  PMID: 12036396 BACKGROUND

• 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.

  PMID: 10668777 BACKGROUND

• 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. doi: 10.1053/apmr.2000.9389.

  PMID: 11083357 BACKGROUND

• Kirkley A, Griffin S, Dainty K. Scoring systems for the functional assessment of the shoulder. Arthroscopy. 2003 Dec;19(10):1109-20. doi: 10.1016/j.arthro.2003.10.030.

  PMID: 14673454 BACKGROUND

• Gaspar PD, Willis FB. Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskelet Disord. 2009 Sep 7;10:111. doi: 10.1186/1471-2474-10-111.

  PMID: 19735563 DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Buck Willis, PhD

  Dynasplint Systems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: January 1, 2006
• Primary Completion: January 1, 2014
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

US (3)