Question: In patients with a painful stiff shoulder for =3
months, is arthrographic distension with normal saline solution and
corticosteroid effective for improving function, pain, and range of
motion?
Design: Randomized (allocation concealed), blinded (patients,
health-care providers, and outcome assessor), placebo-controlled trial with 3,
6, and 12 weeks of follow-up.
Setting: Community-based rheumatology practices in Victoria,
Australia.
Patients: 46 patients who were =18 years of age (mean age 57 y,
80% women), had pain and stiffness in predominantly 1 shoulder for =3
months (range, 96 to 402 d), and had restriction of passive motion of
>30° in =2 planes of movement. Exclusion criteria included severe
pain (>7 of 10 on visual analog scale) at rest, previous arthrographic
distension, systemic inflammatory joint disease, osteoarthritis of the
shoulder, calcification about the shoulder joint, and clinical suspicion of a
complete rotator cuff tear. Follow-up was complete.
Intervention: 25 patients were allocated to arthrographic
distension, and 21 patients were allocated to sham distension. For the control
group, after administration of a local anesthetic, the arthrogram needle was
positioned and 0.5 to 1 mL of contrast material was injected to confirm the
needle position. After an additional 6 mL of contrast material was injected, a
radiograph was made, concluding the procedure for the control group. The
active group received 1 mL of methylprednisolone acetate and up to 82 mL of
normal saline solution (total volume, 30 to 90 mL). The procedure ended after
1 of the following: filling of the subscapular bursa, capsular rupture,
injection of the total 90-mL volume, request for termination of the procedure
by the patient, severe pain, allergic reaction to the injected materials, or
diagnosis of a complete rotator cuff tear. All patients received a simple
exercise program (pendulum exercises and scapular setting). Patients were
allowed to take acetaminophen or codeine preparations but not nonsteroidal
anti-inflammatory drugs. No manual treatments or other medical interventions
were allowed.
Main outcome measures: Disability (The Shoulder Pain and Disability
Index, maximum score 100, higher score = more pain, disability, or both;
Problem Elicitation Technique [PET], higher score indicates higher degree of
patient-perceived disability), pain (Likert scale, 0 [no pain] to 10 [maximum
imaginable pain]), range of active motion (active total shoulder flexion and
abduction, external rotation in neutral, and hand behind back), and adverse
effects.
Main results: Analysis was by intention to treat. At 3 weeks, the
arthrographic distension group showed greater improvement than the placebo
group for disability, pain, shoulder abduction, and hand behind back. At 6 and
12 weeks, the difference in PET scores remained. No serious adverse effects
were reported.
Conclusions: In patients with a painful stiff shoulder,
arthrographic distension with normal saline solution and corticosteroid
reduced pain and disability and improved the range of motion in the short
term.
While we agree that some patients will have early rupture through the
weakest part of the capsule, we observed other patients with appreciable
distension of the capsule on radiographs made just after the procedure. The
important outcome is the clinical improvement, not the process by which it was
obtained. Future studies may be directed to the determination of whether early
termination of the procedure and/or early rupture results in a less
satisfactory outcome.