OBJECTIVE: To compare the efficacy of prolotherapy versus corticosteroid injection for the treatment of chronic lateral epicondylosis. DESIGN: A prospective, randomized controlled, double-blinded study. SETTING: Academic, tertiary, outpatient, rehabilitation hospital. PARTICIPANTS: Twenty-four subjects with clinically determined chronic (ie, lasting 3 months or longer) lateral epicondylosis were recruited. All subjects noted pain intensity levels significant enough to prevent the participation in activities, such as playing racquet sports or lifting heavy objects. METHODS: Subjects were assigned to receive either prolotherapy or corticosteroid injection for treatment of chronic lateral epicondylosis. Each subject underwent injection at baseline followed by a second injection 1 month later. OUTCOME MEASUREMENTS: Visual analog scale (VAS) self-rating of pain, quadruple visual analog scale (QVAS), and the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH) were measured at baseline and at 1, 3, and 6 months' follow-up. RESULTS: Within each group, the analysis demonstrated statistically significant improvements in both VAS and DASH within the prolotherapy group with significant changes noted from baseline to 3 months (VAS: Δ2.38; 95% confidence interval [95% CI] 1.04-3.71, P = .004 and DASH: Δ19.89; 95% CI 5.73-34.04, P = .01), and baseline to 6 months (VAS: Δ2.63; 95% CI 0.61-4.62, P = .017 and DASH: Δ21.76; 9% CI 7.43-36.09, P = .009) after initial treatment, as well as in the QVAS from baseline to 3 months. The steroid group demonstrated a clinically and statistically significant change for DASH only at both 3-month (Δ13.33; 95% CI 0.68-25.99, P = .04) and 6-month (Δ15.56; 95% CI 1.30-29.81, P = .04) follow-up. Comparison of the subjects completing the study revealed no significant differences between the prolotherapy and the corticosteroid group for change in VAS, QVAS, or DASH, although the study lacked sufficient power to draw conclusions from this finding. Eighty-three percent of the subjects were satisfied with their overall improvement during the course of the study, without significant differences revealed between groups. Aside from injection-associated pain, no adverse reactions were reported. Seventeen subjects completed study protocol. CONCLUSIONS: Both prolotherapy and corticosteroid therapy were generally well tolerated and appeared to provide benefit of long duration. Small sample size precludes determining whether one therapy is superior to the other. Larger, controlled trials appear feasible and warranted on the basis of these findings.
RCT Entities:
OBJECTIVE: To compare the efficacy of prolotherapy versus corticosteroid injection for the treatment of chronic lateral epicondylosis. DESIGN: A prospective, randomized controlled, double-blinded study. SETTING: Academic, tertiary, outpatient, rehabilitation hospital. PARTICIPANTS: Twenty-four subjects with clinically determined chronic (ie, lasting 3 months or longer) lateral epicondylosis were recruited. All subjects noted pain intensity levels significant enough to prevent the participation in activities, such as playing racquet sports or lifting heavy objects. METHODS: Subjects were assigned to receive either prolotherapy or corticosteroid injection for treatment of chronic lateral epicondylosis. Each subject underwent injection at baseline followed by a second injection 1 month later. OUTCOME MEASUREMENTS: Visual analog scale (VAS) self-rating of pain, quadruple visual analog scale (QVAS), and the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH) were measured at baseline and at 1, 3, and 6 months' follow-up. RESULTS: Within each group, the analysis demonstrated statistically significant improvements in both VAS and DASH within the prolotherapy group with significant changes noted from baseline to 3 months (VAS: Δ2.38; 95% confidence interval [95% CI] 1.04-3.71, P = .004 and DASH: Δ19.89; 95% CI 5.73-34.04, P = .01), and baseline to 6 months (VAS: Δ2.63; 95% CI 0.61-4.62, P = .017 and DASH: Δ21.76; 9% CI 7.43-36.09, P = .009) after initial treatment, as well as in the QVAS from baseline to 3 months. The steroid group demonstrated a clinically and statistically significant change for DASH only at both 3-month (Δ13.33; 95% CI 0.68-25.99, P = .04) and 6-month (Δ15.56; 95% CI 1.30-29.81, P = .04) follow-up. Comparison of the subjects completing the study revealed no significant differences between the prolotherapy and the corticosteroid group for change in VAS, QVAS, or DASH, although the study lacked sufficient power to draw conclusions from this finding. Eighty-three percent of the subjects were satisfied with their overall improvement during the course of the study, without significant differences revealed between groups. Aside from injection-associated pain, no adverse reactions were reported. Seventeen subjects completed study protocol. CONCLUSIONS: Both prolotherapy and corticosteroid therapy were generally well tolerated and appeared to provide benefit of long duration. Small sample size precludes determining whether one therapy is superior to the other. Larger, controlled trials appear feasible and warranted on the basis of these findings.