Foot Reflexology for Chronic Low Back Pain

NCT06828016 | Recruiting

• 1 other identifier: FJUH112342
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Foot Reflexology

Keywords

chronic low back pain; foot reflexology

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  The change of Oswestry Disability Index

  From enrollment to the end of treatment at 12 week

Secondary Outcomes (4)

• Pain Visual Analogue Scale

  From enrollment to the end of treatment at 12 week

• Activation Deactivation Adjective Check List

  From enrollment to the end of treatment at 12 week

• 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

  From enrollment to the end of treatment at 12 week

Study Arms (3)

High-frequency and LBP-focused intervention group

EXPERIMENTAL

foot reflexology, twice weekly, focusing on low back pain, with a total of 12 sessions

Other: foot reflexology

LBP-focused intervention group

EXPERIMENTAL

foot reflexology, once weekly, focusing on low back pain, with a total of 6 sessions

Other: foot reflexology

usual care group

SHAM COMPARATOR

usual foot care once weekly, primarily for usual foot care, with a total of 6 sessions

Other: usual foot care

Interventions

foot reflexology OTHER

foot reflexology, each session lasting 45 minutes to 1 hour

High-frequency and LBP-focused intervention group; LBP-focused intervention group

usual foot care OTHER

usual foot care, with each session lasting 45 minutes to 1 hour

usual care group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic low back pain for more than 12 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, 24352, Taiwan

RECRUITING

Study Officials

• Ssu-Yuan Chen, MD, PhD,

  Fu Jen Catholic University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ssu-Yuan Chen, MD, PhD,

CONTACT

886-9-05771580; ssuyuan@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: January 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)