Introduction： Foot reflexology is a simple, inexpensive, and non-invasive treatment
commonly used to treat various pain problems. The literature review found that Taiwan has
not applied clinical trial research methods to evaluate the interventional effectiveness
of foot reflexology for chronic low back pain. Therefore, the effect of foot reflexology
on chronic low back pain deserves and requires further research.
Objective： The aim of this 2-year randomized, double-blinded clinical trial is to
investigate the effect of 6 or 12 sessions of weekly 45-minute to 1-hour foot reflexology
interventions on physical function and symptoms, pain, health-related quality of life,
and ultrasonic shear wave elasticity of plantar fascia among chronic low back pain
patients.
Methods： The patients, 18 years of age or older, with chronic low back pain treated at a
regional hospital, will be referred and evaluated for eligibility for the study. The
intervention period for foot reflexology is 6-8 weeks, with each session lasting 45
minutes to 1 hour. Participants were divided into three groups using double-blind random
assignment based on the level of focus on the low back pain foot reflex zone
(LBP-focused) and the frequency of sessions (twice or once per week): the high-frequency
and LBP-focused intervention group (twice weekly, focusing on low back pain, with a total
of 12 sessions), the LBP-focused intervention group (once weekly, focusing on low back
pain, with a total of 6 sessions), and the usual care group (once weekly, primarily for
usual foot care, with a total of 6 sessions). The primary outcome was the change in
Oswestry Disability Index. The secondary outcome measures include Pain Visual Analogue
Scale, Activation Deactivation Adjective Check List, health-related quality of life by
Short Form-36, and Shear Wave PLUS Elastography of plantar fascia.
What is New or Innovative in this Study? There is limited evidence regarding efficacy for
patients with chronic low back pain undergoing foot reflexology intervention. This
prospective randomized, double-blinded, controlled trial will add knowledge regarding
foot reflexology for patients with chronic low back pain.
Scientific or Clinical Implication of the Expected Results： The results of this study
will explore the effect of foot reflexology intervention on physical function and
symptoms, pain, health-related quality of life, and ultrasonic shear wave elasticity of
plantar fascia among chronic low back pain patients. Our data will also provide relevant
scientific evidence and insight into the utility of foot reflexology for the management
of chronic low back pain.