Clinical trial NCT00873158: Dynamic Splinting for Patients With Adhesive Capsulitis
Official title: Outcomes Following Dynamic Splinting and/or Physical Therapy for Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Adhesive Capsulitis
ROM
Dynasplint
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: McMurry University
First posted: 2009-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of physical therapy treatments required
timeFrame: throughout trial
measure: Weeks of Dynasplint treatment
timeFrame: throughout trial
Secondary outcomes:
measure: Shoulder Range Of Motion
timeFrame: initial consultation, first visit following injection, and monthly following injection
measure: Sharp FAS Neck and Shoulder
timeFrame: initial consultation, immediatly prior to first treatment following injection, and monthly following injection
measure: Disabilities of Arm, Hand, and Shoulder Questionnaire
timeFrame: initial visit, first visit following injection, and weekly until discharge
Other outcomes:
Locations:
city: Solana Beach
country: United States
facility: Gaspar Physical Therapy
state: California
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Institute
state: Florida
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
Study officials:
affiliation: Dynasplint Systems, Inc.
name: Buck Willis, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
citation: Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000 Mar;(372):95-109.
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.
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.
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.
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. doi: 10.1053/apmr.2000.9389.
citation: 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.
citation: 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.