Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID06828016

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

Led by Fu Jen Catholic University Hospital · Updated on 2025-02-14

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating foot reflexology as a treatment for people with chronic low back pain lasting more than 12 weeks. This 2-year randomized, double-blinded clinical trial aims to study how 6 or 12 weekly sessions of foot reflexology, each lasting 45 minutes to 1 hour, may affect physical function, pain symptoms, health-related quality of life, and the elasticity of the plantar fascia measured by ultrasound. The study will provide scientific evidence on the usefulness of foot reflexology for managing chronic low back pain. Participants will be randomly assigned to one of three groups: a high-frequency group receiving twice-weekly foot reflexology focused on low back pain for 12 sessions, a group receiving once-weekly foot reflexology focused on low back pain for 6 sessions, or a usual care group receiving once-weekly usual foot care for 6 sessions. The treatments take place over 6 to 8 weeks, with careful monitoring to maintain the double-blinded design. During the study, participants will be assessed using several measures including the Oswestry Disability Index as the primary outcome, along with pain scales, activity and mood checklists, quality of life questionnaires, and ultrasound elastography of the plantar fascia. These evaluations occur from enrollment through 12 weeks to track changes. The research team will observe treatment effects and safety outcomes throughout the trial period.

CONDITIONS

Brief Title

Foot Reflexology for Chronic Low Back Pain

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic low back pain lasting more than 12 weeks
  • Adults aged 18 to 100 years
  • Able to participate in foot reflexology sessions lasting 45 minutes to 1 hour
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Major injuries or illnesses covered by National Health Insurance
  • Diagnosed major mental illness or under mental health care
  • History of adverse reactions to foot reflexology
  • Recent surgery or vascular disease of the lower extremities
  • Any contraindications to foot reflexology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 8 weeks

Participants receive foot reflexology or usual foot care sessions focusing on managing chronic low back pain.

Twice weekly visits for up to 12 sessions or once weekly visits for up to 6 sessions, depending on group assignment

Follow-up

Duration - Up to 12 weeks from enrollment to end of treatment

Participants are monitored for changes in physical function, pain, quality of life, and plantar fascia elasticity after completing treatment.

Visits aligned with treatment completion assessments

Trial Site Locations

Total: 1 location

1

Fu Jen Catholic University Hospital

New Taipei City, Taiwan, 24352

Actively Recruiting

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Research Team

S

Ssu-Yuan Chen, MD, PhD,

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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