Prolotherapy, physiotherapy and combination care for lateral epicondylalgia: a 3-arm single-blinded randomized clinical trial

Context: Lateral epicondylalgia (LE, tennis elbow) is common, debilitating and often refractory to routine care. Prolotherapy and physical therapist-guided manual therapy with exercise (PT) are safe, evidence-based modalities, but have not been compared. Objective: Compare short- and long-term clinical effectiveness and cost of prolotherapy, PT and the two combined. Study Design: 3-arm, single-blinded randomized clinical trial. Analysis by intention-to-treat. Setting and Participants: University-based outpatient practice; Gold Coast, Australia. Participants had LE for at least 6 weeks. Intervention: Participants were randomly allocated (1:1:1) to Prolotherapy (4 monthly sessions), (PT, 4 weekly sessions) or both (combined care). The outcomes assessor was blinded to allocation. Outcome Measures: Primary: disease-specific quality of life (Patient-Rated Tennis Elbow Evaluation; PRTEE, 100 points; assessed at baseline, 6, 12, 26 and 52 weeks). Secondary: overall quality of life (EuroQoL 5D questionnaire); treatment success (6-point Likert scale, “much improved” or “completely recovered”); and cost of care. Results: 120 participants (52 female) were analyzed; the groups were similar at baseline. Adherence to treatment was 93% or more in all groups; 88% completed the 12-month assessment, at which time all groups reported PRTEE score improvements of approximately 28 points, more than twice the minimal clinical important difference, compared with baseline status (p<.001), but without differences between groups (p=.23). The PT group improved more rapidly than did the prolotherapy group, with greater PRTEE score improvement at 12 weeks (p=0.014). The EuroQol was significantly improved at 52 weeks over time in all groups (p=0.002), with no significant differences between groups over time (p=0.63). There were no differences in treatment success or cost between groups. Blinding was intact. Conclusion: Prolotherapy, PT and combined therapy resulted in safe, significant, substantial and sustained improvement of PRTEE-based elbow pain and function by 52 weeks; PT participants improved more quickly. Combined care did not improve outcomes.