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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Imelda Hospital, Bonheiden
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Symons Rolf, Imelda Hospital, Bonheiden
ClinicalTrials.gov Identifier:
NCT01983527
First received: November 7, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Adhesive Capsulitis
Frozen Shoulder
Procedure: Arthrographic distention
Drug: Intra-articular corticosteroid Depo Medrol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imelda Hospital, Bonheiden:

Primary Outcome Measures:
  • Shoulder pain and disability index(SPADI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder pain and disability index (SPADI) [ Time Frame: weekly for a period of 3 months plus at follow-up (4 months and 12 months) ] [ Designated as safety issue: No ]
  • Overall pain score [ Time Frame: weekly for a period of 3 months, plus at follow-up (4 months and 12 months) ] [ Designated as safety issue: No ]
    Universal pain scale

  • Range of motion [ Time Frame: 4 weeks, 4 months and 12 months ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 132
Study Start Date: December 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983527

Contacts
Contact: Rolf Symons, MD +32(0)15/50.62.31 rolf.symons@imelda.be

Locations
Belgium
Imelda Hospital Not yet recruiting
Bonheiden, Antwerpen, Belgium, 2820
Contact: Rolf Symons, MD    +32(0)15/50.62.31    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         
Sponsors and Collaborators
Imelda Hospital, Bonheiden
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Rolf Symons, MD Imelda Hospital
  More Information

Publications:
Responsible Party: Symons Rolf, Symons Rolf, MD, Imelda Hospital, Bonheiden
ClinicalTrials.gov Identifier: NCT01983527     History of Changes
Other Study ID Numbers: CADAC
Study First Received: November 7, 2013
Last Updated: November 13, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Imelda Hospital, Bonheiden:
Arthrographic distention
Hydrodilatation
Intra-articular corticosteroid injection

Additional relevant MeSH terms:
Dilatation, Pathologic
Bursitis
Periarthritis
Pathological Conditions, Anatomical
Joint Diseases
Musculoskeletal Diseases
Arthritis
Anesthetics, Local
Anesthetics
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 14, 2014