Foot Reflexology for Chronic Low Back Pain

February 10, 2025 updated by: Fu Jen Catholic University Hospital

A Randomized Controlled Study of Foot Reflexology for the Management of Chronic Low Back Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Recruiting
        • Fu Jen Catholic University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-frequency and LBP-focused intervention group
foot reflexology, twice weekly, focusing on low back pain, with a total of 12 sessions
Other: foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour
Experimental: LBP-focused intervention group
foot reflexology, once weekly, focusing on low back pain, with a total of 6 sessions
Other: foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour
Sham Comparator: usual care group
usual foot care once weekly, primarily for usual foot care, with a total of 6 sessions
Other: usual foot care
usual foot care, with each session lasting 45 minutes to 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: From enrollment to the end of treatment at 12 week
The change of Oswestry Disability Index
From enrollment to the end of treatment at 12 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University Hospital

Investigators

  • Principal Investigator: Ssu-Yuan Chen, MD, PhD,, Fu Jen Catholic University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH112342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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