Prolotherapy for Refractory Rotator Cuff Disease: Retrospective Case-Control Study of 1-Year Follow-Up.

Abstract

OBJECTIVE: To determine the efficacy of prolotherapy for refractory rotator cuff disease.

DESIGN: Retrospective case-control study.

SETTING: University-affiliated tertiary care hospital.

PARTICIPANTS: Patients with nontraumatic refractory rotator cuff disease (N=151) who were unresponsive to 3 months of aggressive conservative treatment. Of the patients, 63 received prolotherapies with 16.5% dextrose 10-ml solution (treatment group), and 63 continued conservative treatment (control group).

INTERVENTIONS: Not applicable.

MAIN OUTCOME MEASURES: Visual analog scale (VAS) score of the average shoulder pain level for the past 1 week, Shoulder Pain and Disability Index (SPADI) score, isometric strength of the shoulder abductor, active range of motion (AROM) of the shoulder, maximal tear size on ultrasonography, and number of analgesic ingestions per day.

RESULTS: Over 1-year follow-up, 57 patients in the treatment group and 53 in the control group were analyzed. There was no significant difference between the 2 groups in age, sex, shoulder dominance, duration of symptoms, and ultrasonographic findings at pretreatment. The average number of injections in the treatment group is 4.8±1.3. Compared with the control group, VAS score, SPADI score, isometric strength of shoulder abductor, and shoulder AROM of flexion, abduction, and external rotation showed significant improvement in the treatment group. There were no adverse events.

CONCLUSIONS: To our knowledge, this is the first study to assess the efficacy of prolotherapy in rotator cuff disease. Prolotherapy showed improvement in pain, disability, isometric strength, and shoulder AROM in patients with refractory chronic rotator cuff disease. The results suggest positive outcomes, but one should still take caution in directly interpreting it as an effective treatment option, considering the limitations of this nonrandomized retrospective study. To show the efficacy of prolotherapy, further studies on prospective randomized controlled trials will be required.