OBJECTIVE: The aim of this study was to compare the efficacy of ultrasound (US) and ketoprofen phonophoresis (PH) in the treatment of carpal tunnel syndrome (CTS). DESIGN: This study was a prospective, randomised, controlled, double-blinded clinical trial with follow-up at 8 weeks. Fiftyone patients (76 median nerves) with clinical and electrophysiologic evidence of mild or moderate CTS were included in the study. They were randomly assigned to one of three groups; group 1 received sham US and splinting, group 2 received US and splinting, and group 3 received ketoprofen phonophoresis and splinting. Patients were evaluated by use of electrophysiological variables such as median motor distal latency (mMDL), median sensory distal latency (mSDL), functional status scale (FSS), symptom severity scale (SSS) and visual analog scale (VAS). Electrophysiological variables and scales were evaluated at the beginning, end of therapy (2nd week) and 8th week. RESULTS: All the randomised patients were included in the intention-to-treat (ITT) analysis. The per protocol (PP) analysis included only those patients who complied with the study protocol. After completing 2 weeks of treatment, seven out of 51 randomized patients did not finish the study protocol due to non-compliance to splinting, illness and lost to follow-up. Those patients were excluded from PP analysis. Participants were similar in all clinical, electrophysiological and demographic respects (p>0.05). An improvement was found in all parameters (VAS, FSS, SSS, mMDL and mSDL) for all groups at the end of the treatment and 8th week. It was found that pain score was significantly lower in group 3 compared to other treatment groups at 8th week according to ITT and PP analysis (p= 0.002, p=0.004 and p=0.001, p=0.001). CONCLUSION:Ketoprofen PH as adjuvant therapy on splinting is effective with respect to reduction of pain. Adding US therapy to the splinting is not superior to the splinting alone in patients with CTS.
RCT Entities:
OBJECTIVE: The aim of this study was to compare the efficacy of ultrasound (US) and ketoprofen phonophoresis (PH) in the treatment of carpal tunnel syndrome (CTS). DESIGN: This study was a prospective, randomised, controlled, double-blinded clinical trial with follow-up at 8 weeks. Fiftyone patients (76 median nerves) with clinical and electrophysiologic evidence of mild or moderate CTS were included in the study. They were randomly assigned to one of three groups; group 1 received sham US and splinting, group 2 received US and splinting, and group 3 received ketoprofen phonophoresis and splinting. Patients were evaluated by use of electrophysiological variables such as median motor distal latency (mMDL), median sensory distal latency (mSDL), functional status scale (FSS), symptom severity scale (SSS) and visual analog scale (VAS). Electrophysiological variables and scales were evaluated at the beginning, end of therapy (2nd week) and 8th week. RESULTS: All the randomised patients were included in the intention-to-treat (ITT) analysis. The per protocol (PP) analysis included only those patients who complied with the study protocol. After completing 2 weeks of treatment, seven out of 51 randomized patients did not finish the study protocol due to non-compliance to splinting, illness and lost to follow-up. Those patients were excluded from PP analysis. Participants were similar in all clinical, electrophysiological and demographic respects (p>0.05). An improvement was found in all parameters (VAS, FSS, SSS, mMDL and mSDL) for all groups at the end of the treatment and 8th week. It was found that pain score was significantly lower in group 3 compared to other treatment groups at 8th week according to ITT and PP analysis (p= 0.002, p=0.004 and p=0.001, p=0.001). CONCLUSION:Ketoprofen PH as adjuvant therapy on splinting is effective with respect to reduction of pain. Adding US therapy to the splinting is not superior to the splinting alone in patients with CTS.