Prospective, Randomized, Double-Blinded, Sham-Controlled Pilot Study of Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome

Abstract

ObjectiveTo perform a pilot study to assess the efficacy of intraneural facilitation, a novel manual technique, in the treatment of carpal tunnel syndrome (CTS). DesignPatients with clinical and electrodiagnostic evidence of CTS were randomized into intraneural facilitation or sham groups. SettingElectrodiagnostic laboratory in a university medical center. ParticipantsPatients referred to our electrodiagnostic laboratory were screened based on nerve conduction studies that were diagnostic for distal median neuropathy at the wrist or CTS. A total of 14 participants were enrolled; 4 participants withdrew prior to randomization, with the remaining 10 participants (N=10) divided equally between treatment and control groups. There was a 9:1 female-to-male sex ratio and average duration of symptoms was 28.5 months. InterventionsTreatment was performed twice weekly for 3 weeks. Main Outcome MeasuresPrimary outcomes were the Boston Carpel Tunnel Questionnaire (BCTQ) and Boston Functional Status Scale at enrollment and at 1 week and 3 months after completion of intervention. A secondary outcome was ultrasonography (US) of the median nerve performed at baseline and 1 week after intervention. ResultsTen participants completed the trial, 5 each in the treatment and 5 each in the sham groups. The total percentage change in BCTQ and Boston Functional Status Scale scores decreased at baseline, 1 week, and 3 months after intervention. However, there was no difference between control and intraneural facilitation group. Within-group differences showed nonstatistically significant differences for all the groups except for the BCTQ questionnaires after 3 months of intraneural facilitation therapy was completed (P=.043) compared with baseline. Between-group differences showed large effects for the BCTQ questionnaires (d=1.933) and wrist to forearm ratio (WFR) 1 week after completion of intervention. ConclusionsThis pilot study suggests that intraneural facilitation might improve symptoms and possibly function but did not improve median nerve cross-sectional area or WFR in CTS at follow-up evaluation 3 months after completion of intervention.