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2016 ; 474
(11
): 2327-2336
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CORR(®) ORS Richard A Brand Award: Clinical Trials of a New Treatment Method for
Adhesive Capsulitis
#MMPMID27160746
Badalamente MA
; Wang ED
Clin Orthop Relat Res
2016[Nov]; 474
(11
): 2327-2336
PMID27160746
show ga
BACKGROUND: Conservative and even surgical management of adhesive capsulitis
often is prolonged and painful. Management of adhesive capsulitis is lacking
evidence-based controlled clinical trials. QUESTIONS/PURPOSES: We asked: (1) Does
a collagenase clostridium histolyticum (CCH) injection lyse shoulder capsule
collagen in adhesive capsulitis and at what dose? (2) Can a shoulder capsule
injection be administered extraarticularly? (3) Do CCH injections result in
better scores for pain and function than can be achieved with physical therapy
among patients with adhesive capsulitis? METHODS: First, 60 patients with
adhesive capsulitis were evaluated by clinical examination. To make the diagnosis
of adhesive capsulitis, a patient had to have restricted active ROM of at least
60° in total active ROM in the affected shoulder compared with the unaffected
contralateral shoulder; with the scapula stabilized, external rotation with the
elbow at the side was a very important determinant. Patients were randomized to
receive a single injection of 0.5 mL placebo or 0.145, 0.29, or 0.58 mg CCH. All
60 patients were followed up at 30 days. After that, if patients did not attain
treatment thresholds they were eligible for up to five open-label 0.58-mg
collagenase injections. For the longer-term followup in the open-label phase, 53
patients (83%) were followed to 12 months, 46 (77%) for 24 months, 36 (60%) for
36 months, 37 (62%) for 48 months, and 25 (42%) for 60 months. The extraarticular
injection was directed at the anterior shoulder capsule with the patient in the
supine position. To prove that these injections could be delivered reliably to
the anterior shoulder capsule extraarticularly, the next study involved
volunteers without adhesive capsulitis, in which 10 volunteers received a 10-mL
injection of normal saline under ultrasound guidance. Finally, to determine the
efficacy and dosing of CCH, four cohorts of 10 patients received up to three
ultrasound-guided injections separated by 21 days. These injections were
administered at one of four dose-volume levels. A fifth cohort of 10 patients was
used as a control group and performed standardized home shoulder exercises only.
All patients performed standardized home shoulder exercises three times daily.
For Study 3, followup was at 22, 43, 64, and 92 days. No patients were lost to
followup. RESULTS: In the first study, a single CCH injection did not provide
clinically important improvements from baseline in active ROM, passive ROM, and
function and pain scores compared with patients who received placebo. Ultrasound
guidance confirmed extraarticular injection of the shoulder capsule in Study 2.
The CCH injection was more effective than exercise therapy alone at 0.58 mg/1 mL
and 0.58 mg/2 mL compared with exercise only in the primary measure of efficacy
(active forward flexion) as shown in Study 3. For active forward flexion the mean
in degrees in the 0.58 mg/2 mL group was 38° compared with 12° in the
exercise-only group (p = 0.03). For active forward flexion the mean in the 0.58
mg/1mL group was 43° compared with 12° in the exercise-only group (p = 0.01).
CONCLUSIONS: Extraarticular injections of CCH for treatment of adhesive
capsulitis were well tolerated and seem effective compared with exercise therapy.
Future FDA-regulated clinical trials must verify CCH injection therapy for
adhesive capsulitis. LEVEL OF EVIDENCE: Level II, therapeutic study.
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