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

OBJECTIVE

To perform a pilot study to assess the efficacy of intraneural facilitation, a novel manual technique, in the treatment of carpal tunnel syndrome (CTS).

DESIGN

Patients with clinical and electrodiagnostic evidence of CTS were randomized into intraneural facilitation or sham groups.

SETTING

Electrodiagnostic laboratory in a university medical center.

PARTICIPANTS

Patients 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.

INTERVENTIONS

Treatment was performed twice weekly for 3 weeks.

MAIN OUTCOME MEASURES

Primary 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.

RESULTS

Ten 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 (=.043) compared with baseline. Between-group differences showed large effects for the BCTQ questionnaires (=1.933) and wrist to forearm ratio (WFR) 1 week after completion of intervention.

CONCLUSIONS

This 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.