Adhesive CapsulitisCADACNCT01983527
Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis
A study testing Arthrographic distention and Intra-articular corticosteroid Depo Medrol in people with Adhesive Capsulitis and Frozen Shoulder, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- Arthrographic distention and Intra-articular corticosteroid Depo Medrol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Imelda Hospital
Bonheiden, Antwerpen, 2820
Rolf Symons, MD, +32(0)15/50.62.31, rolf.symons@imelda.be
Symons Rolf, MD
About this study
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
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.
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- Arthrographic distention, Intra-articular corticosteroid Depo Medrol
- Keywords
- Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrographic distentionProcedure or surgery
Also called Hydrodilatation
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
Intra-articular corticosteroid Depo MedrolDrug
Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)
| Study group | Role | What they receive |
|---|---|---|
| Arthrographic distention + intra-articular corticosteroid | Experimental | 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. Receives: Procedure: Arthrographic distention; Drug: Intra-articular corticosteroid Depo Medrol |
| Arthrographic distention | Active comparator | Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. Receives: Procedure: Arthrographic distention |
| Intra-articular corticosteroid | Active comparator | Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension). Receives: Drug: Intra-articular corticosteroid Depo Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index(SPADI)
Measured: 4 weeks
Secondary outcomes (3)
Shoulder pain and disability index (SPADI)
Measured: weekly for a period of 3 months plus at follow-up (4 months and 12 months)
Overall pain score
Universal pain scale
Measured: 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)
Measured: 4 weeks, 4 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imelda Hospital, Bonheiden
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Symons Rolf, Imelda Hospital, Bonheiden
- Investigators
- Rolf Symons, MD, Principal investigator, Imeldaziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983527
- Sponsor's protocol ID
- CADAC
- Acronym
- CADAC
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 1855018Corbeil 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.
PubMed 1562888Gam 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.
PubMed 9855212Buchbinder 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.
PubMed 14962967Khan 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.
PubMed 15695959
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01983527
- Acronym / sponsor ID
- CADAC / CADAC
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Keywords
- Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Imelda Hospital, BonheidenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arthrographic distention + intra-articular corticosteroid | Experimental | Procedure: Arthrographic distention, Drug: Intra-articular corticosteroid Depo MedrolArthrographic 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. |
| Arthrographic distention | Active comparator | Procedure: Arthrographic distentionArthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. |
| Intra-articular corticosteroid | Active comparator | Drug: Intra-articular corticosteroid Depo MedrolArthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrographic distentionAlso: HydrodilatationArthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline. | Procedure or surgery | Arthrographic distention, Arthrographic distention + intra-articular corticosteroid |
| Intra-articular corticosteroid Depo MedrolIntra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension) | Drug | Arthrographic distention + intra-articular corticosteroid, Intra-articular corticosteroid |
Primary outcome
Shoulder pain and disability index(SPADI)
Time frame: 4 weeks
3 secondary outcomes
Shoulder pain and disability index (SPADI)
Time frame: weekly for a period of 3 months plus at follow-up (4 months and 12 months)
Overall pain score
Time frame: weekly for a period of 3 months, plus at follow-up (4 months and 12 months)
Range of motion
Time frame: 4 weeks, 4 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Background: PubMed 1855018Jacobs 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.
- Background: PubMed 1562888Corbeil 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.
- Background: PubMed 9855212Gam 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.
- Background: PubMed 14962967Buchbinder 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.
- Background: PubMed 15695959Khan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Symons, MD principal investigator
Imeldaziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrographic distention and Intra-articular corticosteroid Depo Medrol in people with Adhesive Capsulitis and Frozen Shoulder, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolf Symons, MD (+32(0)15/50.62.31, rolf.symons@imelda.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain and disability index(SPADI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983527, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.