Chronic Low Back PainNCT06828016
Foot Reflexology for Chronic Low Back Pain
A study testing foot reflexology and usual foot care in people with Chronic Low Back Pain and Foot Reflexology, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Low Back Pain, Foot Reflexology
- What is being tested?
- foot reflexology and usual foot care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain for more than 12 weeks
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital
New Taipei City, 24352
Ssu-Yuan Chen, MD, PhD, 886-9-05771580, ssuyuan@ntu.edu.tw
About this study
Official title: A Randomized Controlled Study of Foot Reflexology for the Management of Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Foot Reflexology
- Being tested
- foot reflexology, usual foot care
- Keywords
- chronic low back pain, foot reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
foot reflexology, each session lasting 45 minutes to 1 hour
usual foot careOther
usual foot care, with each session lasting 45 minutes to 1 hour
| Study group | Role | What they receive |
|---|---|---|
| High-frequency and LBP-focused intervention group | Experimental | foot reflexology, twice weekly, focusing on low back pain, with a total of 12 sessions Receives: Other: foot reflexology |
| LBP-focused intervention group | Experimental | foot reflexology, once weekly, focusing on low back pain, with a total of 6 sessions Receives: Other: foot reflexology |
| usual care group | Sham comparator | usual foot care once weekly, primarily for usual foot care, with a total of 6 sessions Receives: Other: usual foot care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
The change of Oswestry Disability Index
Measured: From enrollment to the end of treatment at 12 week
Secondary outcomes (4)
Pain Visual Analogue Scale
The change of Pain Visual Analogue Scale
Measured: From enrollment to the end of treatment at 12 week
Activation Deactivation Adjective Check List
The change of Activation Deactivation Adjective Check List
Measured: From enrollment to the end of treatment at 12 week
Health-related quality of life by Short Form-36
The change of health-related quality of life by Short Form-36
Measured: From enrollment to the end of treatment at 12 week
Shear wave elastography of plantar fascia
The change of shear wave elastography of plantar fascia
Measured: From enrollment to the end of treatment at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start18 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ssu-Yuan Chen, MD, PhD,, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828016
- Sponsor's protocol ID
- FJUH112342
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Foot Reflexology for the Management of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06828016
- Acronym / sponsor ID
- FJUH112342
- Conditions
- Chronic Low Back Pain, Foot Reflexology
- Keywords
- chronic low back pain, foot reflexology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency and LBP-focused intervention group | Experimental | Other: foot reflexologyfoot reflexology, twice weekly, focusing on low back pain, with a total of 12 sessions |
| LBP-focused intervention group | Experimental | Other: foot reflexologyfoot reflexology, once weekly, focusing on low back pain, with a total of 6 sessions |
| usual care group | Sham comparator | Other: usual foot careusual foot care once weekly, primarily for usual foot care, with a total of 6 sessions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic low back pain for more than 12 weeks
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot reflexologyfoot reflexology, each session lasting 45 minutes to 1 hour | Other | High-frequency and LBP-focused intervention group, LBP-focused intervention group |
| usual foot careusual foot care, with each session lasting 45 minutes to 1 hour | Other | usual care group |
Primary outcome
Oswestry Disability Index
Time frame: From enrollment to the end of treatment at 12 week
The change of Oswestry Disability Index
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ssu-Yuan Chen, MD, PhD, principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology and usual foot care in people with Chronic Low Back Pain and Foot Reflexology, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ssu-Yuan Chen, MD, PhD, (886-9-05771580, ssuyuan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: From enrollment to the end of treatment at 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.