Clinical trial NCT01961219: Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis
Official title: Manipulation Under Anesthesia Versus Arthroscopic Capsular Release in the Treatment of Adhesive Capsulitis: A Comparison.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adhesive Capsulitis of the Shoulder
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 four months of physical therapy were more likely to eventually require surgery.

The course of progression of untreated adhesive capsulitis is described as a continuum of three clinical phases4. The first phase is characterized by pain and is termed the 'freezing' phase. In this phase, patients experience a gradual onset of diffuse shoulder pain that is progressive over a course of weeks to months. In general, pain will begin before any restriction of motion. Patients may report pain at night and often relate difficulty sleeping on the affected side. As use of the arm decreases secondary to pain, stiffness begins to set in. Phase two is characterized by stiffness and is known as the 'frozen' phase. This phase may last four to twelve months. Patients will see their pain slowly decrease, however, the limitation in motion continually increases. Phase three is known as the 'thawing' phase and may last from five to twenty-six months. This is characterized by resolution of pain and slow improvement in range of motion. Most authors agree that a longer 'freezing' phase is associated with a longer 'thawing' phase.

Adhesive capsulitis is initially treated with nonoperative therapies. The goals of conservative management are control of pain and improvement or maintenance of range of motion. Nonsteroidal anti-inflammatory medications may be prescribed to help control pain. Physical therapy with or without a home exercise program is always employed. This should be done in a gentle manner and without causing too much pain. Treatment with oral or injectable corticosteroids makes theoretical sense given the proven inflammatory nature of the condition. Studies examining treatment with oral steroids versus placebo or no treatment have yielded only short-term improvement of a few weeks. No improvement has been shown at long-term follow up of six to eight months1. There have also been many studies examining the role of intra-articular steroid injections in the treatment of adhesive capsulitis. Similarly, these studies have also shown short term (3weeks) improvement in pain and function but this improvement does not hold up at longer follow up (3-6 months)1. Jones et al11 looked at the role of suprascapular nerve blocks as a treatment option and found significant improvement in pain and shoulder range of motion at three months follow up compared to the group of patients receiving an intra-articular injection of corticosteroid. This suggests a benefit in the short-term but there is no long-term data to reveal if this improvement is lasting. Limited investigation has been performed to determine a role for hydrodilation as a viable treatment option. This involves injection of enough fluid intra-articularly to cause capsular rupture. No level I studies have been performed and only one level II study has been done which suggests some improvement in pain and Constant score up to six months1. Closed Manipulation Under Anesthesia (MUA) has been tested in short and long-term follow up and is proven to be a beneficial tool in the treatment of adhesive capsulitis in patients who have failed other nonoperative therapies. In a report on the results of MUA performed for patients with stage 2 adhesive capsulitis, Dodenhoff et al12 reported that 94% were satisfied with the procedure at mean follow up of 11 months. In a look at long-term outcomes of MUA, Farrell et al13 showed improvement in pain and motion that was continued at an average of 15 year follow up via patient questionnaire. There has been a recent trend toward arthroscopic capsular release in the treatment of refractory adhesive capsulitis and this treatment option has now become more popular than MUA. This rise in popularity of arthroscopic capsular release has occurred because of the perceived benefits of improved outcome and lower risk of complications even though there have not been any higher level trials comparing the two options. Ogilvie-Harris et al14, in a level III study, reported on a cohort of his patients treated with arthroscopic capsular release. He noted that his patients were twice as likely to be pain free at 2 year follow up as a similar cohort who underwent manipulation under anesthesia. Pollock et al15 reported in a level IV study, 83% excellent or satisfactory results after arthroscopic debridement of the rotator interval had been performed concomitantly with MUA. Warner et al16 was able to demonstrate significant improvement in all of his patients treated with arthroscopic capsular release who had failed MUA. This level IV study was performed on patients being treated for postoperative shoulder stiffness, however; not adhesive capsulitis. Both surgical methods (MUA and arthroscopic capsular release are used in our practice.

Eligibility 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

Primary outcomes:
measure: quick Disabilities of the arm, shoulder, and hand (quickDASH) score.
timeFrame: 12 months post-operatively
Secondary outcomes:
measure: quickDASH score
timeFrame: 2 weeks post-operatively
measure: quickDASH score
timeFrame: 4 weeks post-operatively
measure: quickDASH score
timeFrame: 6 weeks post-operatively
measure: quickDASH score
timeFrame: 12 weeks post-operatively
measure: quickDASH
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Centers
state: Missouri
Study officials:
affiliation: University of Missouri-Kansas City Department of Orthopaedic Surgery
name: Akin Cil, MD
role: PRINCIPAL_INVESTIGATOR
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