Tui Na for painful peripheral neuropathy in people with human immunodeficiency virus: A randomized, double-blind, placebo-controlled trial protocol

Xingmei Zhu; Song Ge; Linda Dune; Chao Yang; Chong Tian; Yong Wang

doi:10.3389/fneur.2023.1113834

Tui Na for painful peripheral neuropathy in people with human immunodeficiency virus: A randomized, double-blind, placebo-controlled trial protocol

Front Neurol. 2023 Feb 23:14:1113834. doi: 10.3389/fneur.2023.1113834. eCollection 2023.

Authors

Xingmei Zhu¹, Song Ge², Linda Dune², Chao Yang³, Chong Tian⁴, Yong Wang⁵

Affiliations

¹ Yaxin School of Nursing, Wuhan Institute of Design and Science, Wuhan, Hubei, China.
² Department of Natural Sciences, University of Houston-Downtown, Houston, TX, United States.
³ The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
⁴ School of Nursing, Huazhong University of Science and Technology, Wuhan, China.
⁵ Department of Tuina, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.

Abstract

Background: Peripheral neuropathy (PN), including numbness, loss of sensation, paresthesia, a burning sensation, and stabbing pain in extremities, is a common complication in people with human immunodeficiency virus (PHIV). Medications commonly used to treat HIV-related PN are not effective and lead to many side effects. HIV-related PN symptoms may be alleviated or treated with a series of therapeutic Chinese foot massages (TCFM), which are non-invasive and relatively safe. However, relevant studies are lacking.

Study design: This proposed trial is a prospective, two-arm, parallel, double-blinded, randomized controlled trial.

Aim: This proposed trial aims to assess the effectiveness of TCFM on HIV-related PN in people with HIV (PHIV).

Outcomes: The primary outcomes, measured at baseline, end of TCFM/placebo, and twelve weeks after, include (1), lower extremity pain, (2) lower extremity functioning, and (3) health-related quality of life. The secondary outcomes, measured throughout the trial process, include (1) recruitment and completion rate (No. of referred, No. of eligible, No. of enrolled, No. of withdrawals, trial recruitment rate, and trial completion rate), (2) participants' safety (No. and severity of adverse events), (3) treatment adherence (average time of each message session, No. of completed sessions, and No. of missed sessions), and (4) compliance (No. of participants completing the trial following the initial group assignment).

Sample size: An estimated 142 participants in total, or 71 participants in each arm, will be needed for this trial.

Trial status: This trial was registered at ClinicalTrials.gov of the National Institute of Health on Oct 26, 2022 (ClinicalTrials.gov Identifier: NCT05596123). The researchers expect to recruit participants starting in Feb. 2023 and ending in Feb 2025.

Keywords: HIV; complementary and alternative medicine; massage; neuropathy; pain; randomized controlled trial; traditional Chinese medicine.

Associated data

ClinicalTrials.gov/NCT05596123