Foot Reflexology for Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: foot reflexology, usual foot care.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain, Foot Reflexology. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study of Foot Reflexology for the Management of Chronic Low Back Pain
Overview
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.
Interventions
- Other foot reflexology
foot reflexology, each session lasting 45 minutes to 1 hour - Other usual foot care
usual foot care, with each session lasting 45 minutes to 1 hour
Primary outcome measures
- Oswestry Disability Index [Time frame: From enrollment to the end of treatment at 12 week]
Secondary outcome measures (4)
- Pain Visual Analogue Scale [Time frame: 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]
- Health-related quality of life by Short Form-36 [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Fu Jen Catholic University Hospital — New Taipei City
Identifiers
NCT: NCT06828016 · FJUH112342