Foot Reflexology for Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFu Jen Catholic University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronic low back pain for more than 12 weeks
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
foot reflexology
Other interventionfoot reflexology, each session lasting 45 minutes to 1 hour
usual foot care
Other interventionusual foot care, with each session lasting 45 minutes to 1 hour
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: High-frequency and LBP-focused intervention groupExperimental treatment 1 intervention
Group B: LBP-focused intervention groupExperimental treatment 1 intervention
Group C: usual care groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oswestry Disability Index
The change of Oswestry Disability Index
Time frame
From enrollment to the end of treatment at 12 weekSecondary outcomes
1
Pain Visual Analogue Scale
The change of Pain Visual Analogue Scale
Time frame
From enrollment to the end of treatment at 12 week2
Activation Deactivation Adjective Check List
The change of Activation Deactivation Adjective Check List
Time frame
From enrollment to the end of treatment at 12 week3
Health-related quality of life by Short Form-36
The change of health-related quality of life by Short Form-36
Time frame
From enrollment to the end of treatment at 12 week4
Shear wave elastography of plantar fascia
The change of shear wave elastography of plantar fascia
Time frame
From enrollment to the end of treatment at 12 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov