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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis: A Comparison.

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.

Detailed 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 pathologic entities that can cause shoulder pain and dysfunction. The condition is seen frequently in the clinics of primary care providers and orthopedic surgeons. Patients who develop adhesive capsulitis will typically present with complaints of pain and a progressive loss of active and passive motion of the shoulder.

The disease course of adhesive capsulitis has been extensively studied. Despite this, controversy remains as to the natural history of the disease. It is generally believed that adhesive capsulitis is a self-limiting process typically lasting twelve to thirty-six months. In one retrospective study of 50 patients with 10 year follow up, Miller et al7 found significant improvement in range of motion and resolution of pain in all patients treated conservatively. In another study, it was shown that 90% of patients treated with a stretching exercise program alone reported satisfactory outcomes at a mean follow up of 22 months8. This would mean that up to 10% of patients suffer from long-term problems. Shaffer et al9, however, reported that 50% of patients treated nonoperatively still complained of some residual pain, stiffness, or both at an average follow up of 7 years. Despite evidence that the disease improves without any intervention, many patients do not want to wait potentially as long as two to three years for resolution. For these patients, it is not unreasonable to proceed with interventions aimed at resolution of pain and improvement of motion. Levine et al10 provided some insight into predicting which patients might benefit most from proceeding with surgery. He found that patients who report more severe symptoms, are younger in age at symptom onset, and continue to have a reduction in motion after at least
Sponsor: Akin Cil

Current Primary Outcome: quick Disabilities of the arm, shoulder, and hand (quickDASH) score. [ Time Frame: 12 months post-operatively ]

Original Primary Outcome: quickDASH (disabilities of the arm, shoulder, and hand) score. [ Time Frame: 12 months post-operatively ]

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: University of Missouri, Kansas City

Dates:
Date Received: October 4, 2013
Date Started: November 2013
Date Completion: December 2018
Last Updated: November 17, 2016
Last Verified: November 2016