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

NCT01961219 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-11-02

No results posted yet for this study

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.

Conditions

  • Adhesive Capsulitis of the Shoulder

Interventions

PROCEDURE

Manipulation Under Anesthesia

Closed manipulation under anesthesia.

PROCEDURE

Arthroscopic capsular release

Arthroscopic capsular release

Sponsors & Collaborators

  • Akin Cil

    lead OTHER

Principal Investigators

  • Akin Cil, MD · University of Missouri-Kansas City Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961219 on ClinicalTrials.gov