Foot Reflexology for Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain; Foot Reflexology

• Registration Number: NCT06828016
• Lead Sponsor: Fu Jen Catholic University Hospital

Brief Summary

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. 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-18
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• chronic low back pain for more than 12 weeks

Exclusion Criteria

• pregnancy, patients with comorbidities of major injuries or illnesses of National Health Insurance, patients diagnosed with major mental illness according to DSM-V criteria or under the care of mental health services, patients who have had adverse reactions to foot reflexology before, patients with recent surgery or vascular disease of lower extremities, patients who meet contraindications to foot reflexology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	From enrollment to the end of treatment at 12 week	The change of Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
Pain Visual Analogue Scale	From enrollment to the end of treatment at 12 week	The change of Pain Visual Analogue Scale
Activation Deactivation Adjective Check List	From enrollment to the end of treatment at 12 week	The change of Activation Deactivation Adjective Check List
Health-related quality of life by Short Form-36	From enrollment to the end of treatment at 12 week	The change of health-related quality of life by Short Form-36
Shear wave elastography of plantar fascia	From enrollment to the end of treatment at 12 week	The change of shear wave elastography of plantar fascia

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital; 🇨🇳 New Taipei City, Taiwan