Adhesive CapsulitisPhase 4NCT02001740
An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone
A Phase 4 study testing Triamcinalone (steroid) and lidocaine and Lidocaine in people with Adhesive Capsulitis, run by Queen's University at 1 site in Canada.
Trial summary
Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinalone (steroid) and lidocaine and Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Mar 2015
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 19-70
- Female and male
- Ability to understand and give consent
- Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.
Who cannot join
- • Frozen shoulder secondary to trauma
- Previous surgery on the affected shoulder
- Age less than 19 or greater than 70
- Systemic inflammatory joint disease such as Rheumatoid Arthritis
- Radiographic evidence of osteoarthritis of the shoulder
- Allergy to contrast material
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Kingston General and Hotel Dieu Hospitals
Kingston, Ontario, K7L 2V7
About this study
Official title: Treatment of Adhesive Capsulitis: A Randomized Placebo-Controlled Trial Comparing Arthrographic Joint Distention With Steroid and Local Anesthetic Versus Arthrographic Joint Distention With Local Anesthetic Alone
Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinalone (steroid) and lidocaine, Lidocaine
- Keywords
- shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinalone (steroid) and lidocaineDrug
receive once
LidocaineOther
receive once
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Placebo comparator | frequency = once Receives: Other: Lidocaine |
| Triamcinalone (steroid) and lidocaine | Experimental | frequency = once Receives: Drug: Triamcinalone (steroid) and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcomes as determined by the SPADI
Measured: change in baseline at 1 year.
Secondary outcomes (1)
passive range of motion
Measured: baseline, 3 and 6 and 12 week post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ryan Bicknell, Queen's University
- Investigators
- Ryan Bicknell, MD, Principal investigator, Queen's University and Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001740
- Sponsor's protocol ID
- SURG-246-12
- Status last verified
- Nov 2015
- First submitted
- 20 Aug 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adhesive Capsulitis: A Randomized Placebo-Controlled Trial Comparing Arthrographic Joint Distention With Steroid and Local Anesthetic Versus Arthrographic Joint Distention With Local Anesthetic Alone
- ClinicalTrials.gov ID
- NCT02001740
- Acronym / sponsor ID
- SURG-246-12
- Conditions
- Adhesive Capsulitis
- Keywords
- shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Dec 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.
Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Placebo comparator | Other: Lidocainefrequency = once |
| Triamcinalone (steroid) and lidocaine | Experimental | Drug: Triamcinalone (steroid) and lidocainefrequency = once |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range 19-70
- Female and male
- Ability to understand and give consent
- Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.
Key exclusion criteria (7 listed)
- • Frozen shoulder secondary to trauma
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 |
|---|---|---|
| Triamcinalone (steroid) and lidocainereceive once | Drug | Triamcinalone (steroid) and lidocaine |
| Lidocainereceive once | Other | lidocaine |
Primary outcome
functional outcomes as determined by the SPADI
Time frame: change in baseline at 1 year.
1 secondary outcome
passive range of motion
Time frame: baseline, 3 and 6 and 12 week post injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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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.
Ryan Bicknell, MD principal investigator
Queen's University and Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinalone (steroid) and lidocaine and Lidocaine in people with Adhesive Capsulitis, run by Queen's University at 1 site in Canada.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 24 Nov 2015. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcomes as determined by the SPADI (time frame: change in baseline at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2015.