Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis (CADAC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Adhesive Capsulitis; Frozen Shoulder
• Intervention / Treatment: Procedure: Arthrographic distention; Drug: Intra-articular corticosteroid Depo Medrol

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rolf Symons, MD; Phone Number: +32(0)15/50.62.31; Email: rolf.symons@imelda.be

Study Locations

• Belgium
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Imelda Hospital
      • Contact: Rolf Symons, MD; Phone Number: +32(0)15/50.62.31; Email: rolf.symons@imelda.be
      • Principal Investigator: Symons Rolf, MD
      • Principal Investigator: Demeyere Annick, MD
      • Principal Investigator: Vankan Yoeri, MD
      • Principal Investigator: Perdieus Dirk, MD
      • Principal Investigator: Van Raebroeckx Antoon, MD
      • Principal Investigator: Ruette Peter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthrographic distention + intra-articular corticosteroid; Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.	Procedure: Arthrographic distention; Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.; Other Names: Hydrodilatation; Drug: Intra-articular corticosteroid Depo Medrol; Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)
Active Comparator: Arthrographic distention; Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.	Procedure: Arthrographic distention; Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.; Other Names: Hydrodilatation
Active Comparator: Intra-articular corticosteroid; Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).	Drug: Intra-articular corticosteroid Depo Medrol; Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Shoulder pain and disability index(SPADI)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain and disability index (SPADI)		weekly for a period of 3 months plus at follow-up (4 months and 12 months)
Overall pain score	Universal pain scale	weekly for a period of 3 months, plus at follow-up (4 months and 12 months)
Range of motion	Total shoulder abduction (in degrees, measured with goniometer); External rotation in neutral position (in degrees, measured with goniometer); Hand behind back (highest reachable anatomical landmark)	4 weeks, 4 months and 12 months

Collaborators and Investigators

• Sponsor: Imelda Hospital, Bonheiden
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Rolf Symons, MD, Imeldaziekenhuis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Arthrographic distention; Hydrodilatation; Intra-articular corticosteroid injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Dilatation, Pathologic; Bursitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: CADAC