Frozen ShoulderNCT01606332
Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
A study testing Interscalene block with nerve catheter in people with Frozen Shoulder, run by OAD Orthopaedics at 1 site in United States.
Trial summary
In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Interscalene block with nerve catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2014
- 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
- Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
- Failed conservative treatment for a minimum of 4 months
- Patient had 3 sequential office visits with no clinical improvement
Who cannot join
- Adhesive capsulitis following a surgical procedure and/or fracture
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OAD Orthopaedics
Warrenville, Illinois, 60555
Marjorie L Delaney, APN, 630-225-2554, marjorie.delaney@oadortho.com
About this study
In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.
Read the detailed description
Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.
It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months
- Conditions
- Frozen Shoulder
- Being tested
- Interscalene block with nerve catheter
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene block with nerve catheterProcedure or surgery
Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Single in interscalene block | No intervention | Single indwelling interscalene block with ropivacaine 0.5% 10ml |
| Interscalene block with nerve catheter | Experimental | Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours Receives: Procedure: Interscalene block with nerve catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in shoulder function as demonstrated by increased range of motion
The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.
Measured: 10 days, 4, 8, 16 weeks and 6 months
Secondary outcomes (1)
Decrease in shoulder pain
The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.
Measured: 10 days, 4, 8, 16 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OAD Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron A Bare, MD, Principal investigator, OAD Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606332
- Sponsor's protocol ID
- AC001
- Status last verified
- Jun 2013
- First submitted
- 23 May 2012
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT01606332
- Acronym / sponsor ID
- AC001
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OAD OrthopaedicsUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 25 May 2012 (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.
In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.
Detailed description
Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.
It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single in interscalene block | No intervention | –Single indwelling interscalene block with ropivacaine 0.5% 10ml |
| Interscalene block with nerve catheter | Experimental | Procedure: Interscalene block with nerve catheterInterscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
- Failed conservative treatment for a minimum of 4 months
- Patient had 3 sequential office visits with no clinical improvement
Key exclusion criteria (1 listed)
- Adhesive capsulitis following a surgical procedure and/or fracture
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 |
|---|---|---|
| Interscalene block with nerve catheterInterscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours | Procedure or surgery | Interscalene block with nerve catheter |
Primary outcome
Improvement in shoulder function as demonstrated by increased range of motion
Time frame: 10 days, 4, 8, 16 weeks and 6 months
The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.
1 secondary outcome
Decrease in shoulder pain
Time frame: 10 days, 4, 8, 16 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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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.
Aaron A Bare, MD principal investigator
OAD Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene block with nerve catheter in people with Frozen Shoulder, run by OAD Orthopaedics at 1 site in United States.
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 3 inclusion and 1 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 11 Jun 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 United States. 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 Marjorie Delaney, APN (630-225-2554, marjorie.delaney@oadortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in shoulder function as demonstrated by increased range of motion (time frame: 10 days, 4, 8, 16 weeks and 6 months). 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 11 Jun 2013.