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

NCT01961219 | Terminated

• 1 other identifier: 13-775
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• quick Disabilities of the arm, shoulder, and hand (quickDASH) score.

  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

  12 months post-operatively

Secondary Outcomes (5)

• quickDASH score

  2 weeks post-operatively

• quickDASH score

  4 weeks post-operatively

• quickDASH score

  6 weeks post-operatively

• quickDASH score

  12 weeks post-operatively

• quickDASH

  6 months post-operatively

Study Arms (2)

Adhesive Capsulitis with MUA

ACTIVE COMPARATOR

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

Adhesive Capsulitis with Arthroscopy

ACTIVE COMPARATOR

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

Interventions

Manipulation Under Anesthesia PROCEDURE

Closed manipulation under anesthesia.

Also known as: MUA

Adhesive Capsulitis with MUA

Arthroscopic capsular release PROCEDURE

Arthroscopic capsular release

Adhesive Capsulitis with Arthroscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akin Cil: lead

Study Sites (1)

Truman Medical Centers

Kansas City, Missouri, 64108, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Bursitis

Interventions

Joint Capsule Release

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Akin Cil, MD

  University of Missouri-Kansas City Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 11, 2013
• Study Start: November 1, 2013
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

US (1)