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Prospective, randomized, double-blinded, sham-controlled pilot study of intraneural facilitation as a treatment for carpal tunnel syndrome
Baker NA, Vuong D, Bussell M, Gharibvand L, Lee S, Tsao B
Archives of Rehabilitation Research and Clinical Translation 2022 Jun;4(2):100193
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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). DESIGNS: Patients with clinical and electrodiagnostic evidence of CTS were randomized into intraneural facilitation or sham groups. SETTINGS: 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 to 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 (p = 0.043) 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. 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.

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