NCT01606332

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

May 23, 2012

Last Update Submit

June 10, 2013

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days, 4, 8, 16 weeks and 6 months

Secondary Outcomes (1)

  • Decrease in shoulder pain

    10 days, 4, 8, 16 weeks and 6 months

Study Arms (2)

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

Procedure: Interscalene block with nerve catheter

Interventions

Interscalene block with nerve catheterPROCEDURE

Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours

Interscalene block with nerve catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Adhesive capsulitis following a surgical procedure and/or fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OAD Orthopaedics

Warrenville, Illinois, 60555, United States

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Aaron A Bare, MD

    OAD Orthopaedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie Delaney, APN

CONTACT

630-225-2554marjorie.delaney@oadortho.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)