Reflexology, Hypertension, Acupressure, Traditional MedicineNCT04516005
Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial
A study testing foot reflexology in people with Reflexology, Hypertension, Acupressure, Traditional Medicine, run by Khon Kaen University.
Trial summary
Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Reflexology, Hypertension, Acupressure, Traditional Medicine
- What is being tested?
- foot reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed stage-2 HT (defined by office SBP≥140 mmHg and/or DBP ≥90 mmHg at first hospital visit)
- On stable anti-HT drugs for at least 3 months before enrollment.
Who cannot join
- Pregnant women
- History of foot surgery or bone fracture
- Skin disease of the foot
- Diabetes neuropathy
About this study
Official title: Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial in Stage-2 Hypertensive Patients
Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT. We aimed to examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering. This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.
Read the detailed description
Background Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere to them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of the complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT.
Objective To examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering.
Methods This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.
- Being tested
- foot reflexology
- Keywords
- hypertension, reflexology, acupressure, traditional medicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyProcedure or surgery
Acupressure was applied at the plantar side of the right foot at the first metatarsal bone, around 1-1.5 centimeters proximal to the first metatarsophalangeal joint. (Figure 2) Approximately 3-kilogram pressure was applied by using a knuckle of the right index finger (dorsal part of the proximal interphalangeal joint in flexing position) in a perpendicular manner and held for 15 seconds (sec) then released for 5 sec. This hold-release cycle was done 5 times over the course of 2 min. This method was recommended by the Department of Thai Traditional and Alternative Medicine in accordance with the Zone theory and the Meridian theory.
| Study group | Role | What they receive |
|---|---|---|
| foot reflexology | Experimental | Foot reflexology was performed in every participant in the foot reflexology group after resting for 5 minutes in a sitting position by the same researcher who was trained and certified by the Department of Thai Traditional and Alternative Medicine, Ministry of Health. Receives: Procedure: foot reflexology |
| control | No intervention | The control group received conventional treatment including anti-HT medications according to the standard HT guideline's recommendations. In the end of the follow-up visit, every participants were informed to adhere to their medication and were encouraged to have healthy lifestyles including salt restriction, regular exercise, and consuming healthy diets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure level
The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.
Measured: Change from Baseline Systolic Blood Pressure at 15 minutes
Change of blood pressure level
The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.
Measured: Change from Baseline Systolic Blood Pressure at 30 minutes
Change of pulse rate
The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.
Measured: Change from baseline pulse rate at 15 minutes
Change of pulse rate
The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.
Measured: Change from baseline pulse rate at 30 minutes
Secondary outcomes (2)
Difference in degree of reduction of blood pressure between groups
Compare the degree of reduction of blood pressure between intervention and control group
Measured: Difference in degree of reduction of blood pressure from baseline after 30 min
Difference in degree of reduction of pulse rate between groups
Compare the degree of reduction of pulse rate between intervention and control group
Measured: Difference in degree of reduction of pulse rate from baseline after 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Nov 2015
- Primary completion31 May 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflexology, Hypertension, Acupressure, Traditional MedicineStudies 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
- Model description
- a single-center randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praew Kotruchin, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516005
- Sponsor's protocol ID
- HE611181
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal contact for IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial in Stage-2 Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04516005
- Acronym / sponsor ID
- HE611181
- Keywords
- hypertension, reflexology, acupressure, traditional medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 17 Aug 2020 (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.
Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT. We aimed to examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering. This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.
Detailed description
Background Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere to them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of the complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT.
Objective To examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering.
Methods This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- a single-center randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| foot reflexology | Experimental | Procedure: foot reflexologyFoot reflexology was performed in every participant in the foot reflexology group after resting for 5 minutes in a sitting position by the same researcher who was trained and certified by the Department of Thai Traditional and Alternative Medicine, Ministry of Health. |
| control | No intervention | –The control group received conventional treatment including anti-HT medications according to the standard HT guideline's recommendations. In the end of the follow-up visit, every participants were informed to adhere to their medication and were encouraged to have healthy lifestyles including salt restriction, regular exercise, and consuming healthy diets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed stage-2 HT (defined by office SBP≥140 mmHg and/or DBP ≥90 mmHg at first hospital visit)
- On stable anti-HT drugs for at least 3 months before enrollment.
Key exclusion criteria (4 listed)
- Pregnant women
- History of foot surgery or bone fracture
- Skin disease of the foot
- Diabetes neuropathy
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 reflexologyAcupressure was applied at the plantar side of the right foot at the first metatarsal bone, around 1-1.5 centimeters proximal to the first metatarsophalangeal joint. (Figure 2) Approximately 3-kilogram pressure was applied by using a knuckle of the right index finger (dorsal part of the proximal interphalangeal joint in flexing position) in a perpendicular manner and held for 15 seconds (sec) then released for 5 sec. This hold-release cycle was done 5 times over the course of 2 min. This method was recommended by the Department of Thai Traditional and Alternative Medicine in accordance with the Zone theory and the Meridian theory. | Procedure or surgery | foot reflexology |
Primary outcome
Change of blood pressure level
Time frame: Change from Baseline Systolic Blood Pressure at 15 minutes
The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.
Change of blood pressure level
Time frame: Change from Baseline Systolic Blood Pressure at 30 minutes
The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.
Change of pulse rate
Time frame: Change from baseline pulse rate at 15 minutes
The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.
Change of pulse rate
Time frame: Change from baseline pulse rate at 30 minutes
The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.
2 secondary outcomes
Difference in degree of reduction of blood pressure between groups
Time frame: Difference in degree of reduction of blood pressure from baseline after 30 min
Difference in degree of reduction of pulse rate between groups
Time frame: Difference in degree of reduction of pulse rate from baseline after 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: Yes. Personal contact for IPD
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology in people with Reflexology, Hypertension, Acupressure, Traditional Medicine, run by Khon Kaen University.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure level (time frame: Change from Baseline Systolic Blood Pressure at 15 minutes). The study lists 4 primary outcomes in all. 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 17 Aug 2020.