Clinical trial NCT01983527: Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis
Official title: A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Frozen Shoulder
Keywords: Arthrographic distention
Hydrodilatation
Intra-articular corticosteroid injection
Lead sponsor: Imelda Hospital, Bonheiden
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2013-11-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone.

The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.


Eligibility criteria: Inclusion Criteria:

* Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer
* Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer)

Exclusion Criteria:

* Previous arthrographic distention and/or corticosteroid injection
* Systemic inflammatory joint disease
* Radiological evidence of osteoarthritis of the shoulder or fracture
* Signs of a complete rotator cuff tear
* Contraindications to arthrogram and/or distention
* Lack of written informed consent

Primary outcomes:
measure: Shoulder pain and disability index(SPADI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Shoulder pain and disability index (SPADI)
timeFrame: weekly for a period of 3 months plus at follow-up (4 months and 12 months)
measure: Overall pain score
timeFrame: weekly for a period of 3 months, plus at follow-up (4 months and 12 months)
measure: Range of motion
timeFrame: 4 weeks, 4 months and 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerpen
Study officials:
affiliation: Imeldaziekenhuis
name: Rolf Symons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobs LG, Barton MA, Wallace WA, Ferrousis J, Dunn NA, Bossingham DH. Intra-articular distension and steroids in the management of capsulitis of the shoulder. BMJ. 1991 Jun 22;302(6791):1498-501. doi: 10.1136/bmj.302.6791.1498.
citation: Corbeil V, Dussault RG, Leduc BE, Fleury J. [Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension]. Can Assoc Radiol J. 1992 Apr;43(2):127-30. French.
citation: Gam AN, Schydlowsky P, Rossel I, Remvig L, Jensen EM. Treatment of "frozen shoulder" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial. Scand J Rheumatol. 1998;27(6):425-30. doi: 10.1080/030097498442244.
citation: Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
citation: Khan AA, Mowla A, Shakoor MA, Rahman MR. Arthrographic distension of the shoulder joint in the management of frozen shoulder. Mymensingh Med J. 2005 Jan;14(1):67-70.