Study Results
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Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-01-18
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High-frequency and LBP-focused intervention group
foot reflexology, twice weekly, focusing on low back pain, with a total of 12 sessions
foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour
LBP-focused intervention group
foot reflexology, once weekly, focusing on low back pain, with a total of 6 sessions
foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour
usual care group
usual foot care once weekly, primarily for usual foot care, with a total of 6 sessions
usual foot care
usual foot care, with each session lasting 45 minutes to 1 hour
Interventions
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foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour
usual foot care
usual foot care, with each session lasting 45 minutes to 1 hour
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Fu Jen Catholic University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ssu-Yuan Chen, MD, PhD,
Role: PRINCIPAL_INVESTIGATOR
Fu Jen Catholic University Hospital
Locations
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Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FJUH112342
Identifier Type: -
Identifier Source: org_study_id
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