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Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT01961219
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Akin Cil, University of Missouri, Kansas City

Brief Summary:

Shoulder pain is one of the most common causes of musculoskeletal disability in the adult population. Adhesive capsulitis is one of a multitude of reasons that can cause shoulder pain and dysfunction. It is a painful and disabling condition that can cause frustration for patients and caregivers due to slow recovery time. It is important to meticulously diagnose the source of the symptoms. Adhesive capsulitis is treatment by non-operative therapies such as physical therapy, exercise, steroids & pain medications. For some patients a quicker return to function is necessary; in th is situation an operative treatment is an option. This study will compare two surgical techniques for adhesive capsulitis.

Purpose

  1. To directly compare outcomes of patients with adhesive capsulitis who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment and have subsequently been randomized to either closed manipulation under anesthesia or arthroscopic capsular release.
  2. To blind both patient and assessing physician/nurse study coordinator to the treatment that was received for the duration of the study. This will reduce the effect of any potential bias on the results as much as possible.
  3. To collect outcome data, both subjectively from the patient using proven outcome measures, and objectively from regularly spaced follow up visits with blinded assessors.
  4. To collect and comment on data from the two treatment groups regarding duration of post-operative narcotic use, duration of post-operative physical therapy required, post-operative pain levels, and elapsed time until back to work/activity post-operatively.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of the Shoulder Procedure: Manipulation Under Anesthesia Procedure: Arthroscopic capsular release Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis: A Comparison.
Study Start Date : November 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Adhesive Capsulitis with MUA
Subjects with idiopathic adhesive capsulitis in the "frozen" or "thawing" phase who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment; or who after less than 3 months of conservative treatment demand a quicker return to function. Treatment closed manipulation under anesthesia.
Procedure: Manipulation Under Anesthesia
Closed manipulation under anesthesia.
Other Name: MUA

Active Comparator: Adhesive Capsulitis with Arthroscopy
Subjects with idiopathic adhesive capsulitis in the "frozen" or "thawing" phase who have failed pain management and failed improvement in range of motion after at least 3 months of supervised, regimented conservative treatment; or who after less than 3 months of conservative treatment demand a quicker return to function. Treatment Arthroscopic Capsular Release
Procedure: Arthroscopic capsular release
Arthroscopic capsular release




Primary Outcome Measures :
  1. quick Disabilities of the arm, shoulder, and hand (quickDASH) score. [ Time Frame: 12 months post-operatively ]
    The primary analysis will compare the quickDASH score at the twelve month evaluation between closed manipulation under anesthesia and arthroscopic capsular release using analysis of covariance using the baseline assessment of quickDASH ast he covariate


Secondary Outcome Measures :
  1. quickDASH score [ Time Frame: 2 weeks post-operatively ]
    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

  2. quickDASH score [ Time Frame: 4 weeks post-operatively ]
    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

  3. quickDASH score [ Time Frame: 6 weeks post-operatively ]
    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

  4. quickDASH score [ Time Frame: 12 weeks post-operatively ]
    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.

  5. quickDASH [ Time Frame: 6 months post-operatively ]
    Secondary analysis will look at all longitudinal evaluation time points of quickDASH using a mixed linear regression model to account for correlations across subjects at multiple time points.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients must be diagnosed as having idiopathic adhesive capsulitis in the 'frozen' or 'thawing' phase of disease and have tried and failed at least 3 months of nonoperative therapy.

OR

  • patient with adhesive capsulitis who presents already in the 'frozen' or 'thawing' phase who demands a quicker return to function and will not try 3 months of nonoperative therapy first.
  • Age 18 or older

Exclusion Criteria:

  • pregnancy
  • previously operated shoulder (same side)
  • other documented source of shoulder pain and stiffness (same side)
  • rotator cuff tear (same side)
  • glenohumeral osteoarthritis (same side)
  • calcific tendonitis (same side)
  • impingement (same side)
  • osteonecrosis
  • neoplasm
  • cervical radiculopathy
  • patients who are medically unfit to undergo a general anesthetic
  • patients who are unable to comply with the post-operative protocol
  • non-English Speaking patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961219


Contacts
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Contact: Akin Cil, MD 816-404-5404 akin.cil@tmcmed.org
Contact: Kim Dyer, MS, RN, CCRC kim.dyer@tmcmed.org

Locations
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United States, Missouri
Truman Medical Centers Recruiting
Kansas City, Missouri, United States, 64108
Contact: Akin Cil, MD    816-404-5404      
Contact: Kim Dyer, MS, RN, CCRC       kim.dyer@tmcmed.org   
Sponsors and Collaborators
Akin Cil
Investigators
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Principal Investigator: Akin Cil, MD University of Missouri-Kansas City Department of Orthopaedic Surgery

Publications:
Neviaser JS: Adhesive capsulitis of the shoulder. JBJS 1945;27:211-222.

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Responsible Party: Akin Cil, M.D., University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT01961219     History of Changes
Other Study ID Numbers: 13-775
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs