Local effects of acupuncture on the median and ulnar nerves in patients with carpal tunnel syndrome: a pilot mechanistic study protocol

Abstract

Background: While acupuncture's mechanism of action is not fully understood, there is consensus that the nervous system plays a key role in processing its effects. This research is based on the structural theory of acupuncture, which aims to correlate the location of acupuncture points to peripheral nerves, spinal segments, and spinal plexuses. This mechanistic study explores the close anatomical association between the Pericardium meridian/median nerve and the Heart meridian/ulnar nerve in an attempt to produce electrophysiologic data measuring acupuncture's direct, nerve-specific effect on the underlying nerves. Specifically, the purpose of this research is to use nerve conduction studies (NCSs) and quantitative sensory testing (QST) to assess for any local, nerve-specific effect of three acupuncture modalities on two anatomically distinct nerves in the forearm - the median and ulnar nerves - in subjects with carpal tunnel syndrome (CTS). The choice of CTS as an injured nerve model allows for comparisons between the response in an injured nerve (median) to that of a healthy one (ulnar).

Methods: Subjects with mild to moderate CTS will be randomized to three intervention groups: manual acupuncture and low- and high-frequency electroacupuncture. Each subject will receive two treatments, 1 week apart, to points in the forearm, which overlay the median nerve (Pericardium meridian) or the ulnar nerve (Heart meridian). Acupuncture will be administered in random order to minimize learning effects in sensory testing. During Week 1, baseline NCS and QST (vibration and cold detection thresholds) will be obtained in both nerve territories, followed by acupuncture and post-acupuncture NCS and QST measurements in both nerve territories. During Week 2, repeat baseline QST and NCS measurements will be obtained, followed by acupuncture to points overlying the nerve not treated in Week 1, followed by post-acupuncture NCS and QST measurements in both nerve distributions.

Discussion: This works aims to capture and characterize the local effects of acupuncture on an underlying nerve and compare them to those on a neighboring nerve. Quantifying acupuncture's effects using physiologic parameters and discrete values could standardize treatment regimens and help assess their therapeutic effect.

Trial registration: ClinicalTrials.gov, NCT03036657 . Registered on 30 January 2017. Retrospectively registered.

Keywords: Acupuncture; Electroacupuncture; Electrophysiology; Mechanistic study; Nerve conduction studies; Quantitative sensory testing; Structural acupuncture; Study protocol.

Conflict of interest statement

Ethics approval and consent to participate

The study’s protocol has been approved by OHSU’s IRB since October 2012 (IRB00008949) and will be conducted according to the principles of the Declaration of Helsinki and in compliance with the US legal and regulatory framework for research involving human beings. The study is also registered at ClinicalTrials.gov, NCT03036657. Eligible subjects who are interested in participation will be interviewed by the study PI. The PI will explain the objectives, risks, and benefits of the study, answer all questions, and inform the subjects that they may withdraw consent at any point, prior to obtaining written informed consent for the study. In accordance with OHSU IRB regulations, each subject will be provided with a Lay Language Protocol Summary and a copy of the signed OHSU Consent-and-Authorization form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests

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Figures

Fig. 1

Acupuncture points used

Fig. 2

Study procedures flowchart

Fig. 3

SPIRIT schedule of enrollment

Fig. 4

Pantheon 6c.Pro device