Diabetic NeuropathiesNCT03415256
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
A study testing passive vibration and no passive vibration in people with Diabetic Neuropathies, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- passive vibration and no passive vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2018to Dec 2019
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Diabetic Peripheral Neuropathy
- Minimum age 40 years
- Maximum Age 75 years
- Ability to stand for a minimum of five minutes
Who cannot join
- Neurological Disorders
- Bleeding Disorders
- Leg Ulcers
- Cardiovascular Diseases
- Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
- Self-reported pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).
Read the detailed description
The study involves the following:
- Visit 1:
- Particpant's age, height, gender, and weight will be collected.
- Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
- Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
- After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
- The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
- The control group will not receive any treatment and they will continue their usual lifestyle.
- Visit 2 through 8:
- The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
- The control group will continue their usual lifestyle.
- In the fifth session, the treatment and control groups will come back for tests.
- Visit 9 (follow-up):
- Conditions
- Diabetic Neuropathies
- Being tested
- passive vibration, no passive vibration
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive vibrationOther
The passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time).
no passive vibrationOther
The control group will not receive any treatment and continue their usual lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| passive vibration group | Experimental | The passive vibration group patients will receive passive vibration (50 Hz, one cycle= 60 seconds working time with 2 seconds rest time) on their calf in supine position for ten minutes. The total number of sessions will be nine. Passive vibration will be given to the treatment group twice a week for four weeks (eight sessions) and the ninth session will be the follow up. At every session, the skin blood flow will be measured before, immediately, and 15 minutes after passive vibration. Receives: Other: passive vibration |
| no passive vibration group | Active comparator | The control group will not receive any treatment and continue their usual lifestyle. Balance, sensory measurement and skin blood flow will be taken at the beginning of the study, prior to the 5th treatment, and 1 week after the last intervention . Receives: Other: no passive vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood flow
Patient will be positioned in prone on a plinth as their skin is marked for blood flow assessment. A 3 cm x 3 cm square shape will be marked on the posterior aspect of the calf (muscle belly) and on the plantar aspect of the first three metatarsal heads. MOOR Full-field Laser Perfusion Image(FLPI) (MOOR FLPI V 2.1, Oxford, England) will be used for measurement of skin blood flow in a patient with DPN, which will be pre-warmed for about 30 minutes. The perpendicular red light laser beam will be used to capture SBF and blood flow is measured in '"Flux" unit.
Measured: Change between Baseline and Week Nine Visit
Secondary outcomes (1)
balance
The NeuroCom Smart Balance Master System Computerized dynamic posturography (CDP) will be used in this research to measure balance. The platform consists of two force plates that can be modulated in the up-down and anterior-posterior direction. The sensory organization test (SOT) will be used to measure balance. The result of CDP determines any anomalies in visual, somatosensory and vestibular systems that control posture.
Measured: at each of the nine visits( 90 minutes each visit: twice per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Lack of time currently.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * After completing the tests, you will be randomly assigned by the computer to either the treatment group or control group. * The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks. * The control group will not receive any treatment and they will continue their usual lifestyle.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Everett Lohman, Loma Linda University
- Investigators
- Everett Lohman, DSc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415256
- Sponsor's protocol ID
- 5170453
- Status last verified
- Aug 2018
- First submitted
- 12 Dec 2017
- Last updated
- 28 Feb 2019
- 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 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03415256
- Acronym / sponsor ID
- 5170453
- Conditions
- Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of time currently.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Jan 2018 (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 purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).
Detailed description
The study involves the following:
- Visit 1:
- Particpant's age, height, gender, and weight will be collected.
- Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
- Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
- After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
- The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
- The control group will not receive any treatment and they will continue their usual lifestyle.
- Visit 2 through 8:
- The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
- The control group will continue their usual lifestyle.
- In the fifth session, the treatment and control groups will come back for tests.
- Visit 9 (follow-up):
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * After completing the tests, you will be randomly assigned by the computer to either the treatment group or control group. * The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks. * The control group will not receive any treatment and they will continue their usual lifestyle.
| Arm | Type | Receives |
|---|---|---|
| passive vibration group | Experimental | Other: passive vibrationThe passive vibration group patients will receive passive vibration (50 Hz, one cycle= 60 seconds working time with 2 seconds rest time) on their calf in supine position for ten minutes. The total number of sessions will be nine. Passive vibration will be given to the treatment group twice a week for four weeks (eight sessions) and the ninth session will be the follow up. At every session, the skin blood flow will be measured before, immediately, and 15 minutes after passive vibration. |
| no passive vibration group | Active comparator | Other: no passive vibrationThe control group will not receive any treatment and continue their usual lifestyle. Balance, sensory measurement and skin blood flow will be taken at the beginning of the study, prior to the 5th treatment, and 1 week after the last intervention . |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of Diabetic Peripheral Neuropathy
- Minimum age 40 years
- Maximum Age 75 years
- Ability to stand for a minimum of five minutes
Key exclusion criteria (6 listed)
- Neurological Disorders
- Bleeding Disorders
- Leg Ulcers
- Cardiovascular Diseases
- Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
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 |
|---|---|---|
| passive vibrationThe passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time). | Other | passive vibration group |
| no passive vibrationThe control group will not receive any treatment and continue their usual lifestyle. | Other | no passive vibration group |
Primary outcome
Skin blood flow
Time frame: Change between Baseline and Week Nine Visit
Patient will be positioned in prone on a plinth as their skin is marked for blood flow assessment. A 3 cm x 3 cm square shape will be marked on the posterior aspect of the calf (muscle belly) and on the plantar aspect of the first three metatarsal heads. MOOR Full-field Laser Perfusion Image(FLPI) (MOOR FLPI V 2.1, Oxford, England) will be used for measurement of skin blood flow in a patient with DPN, which will be pre-warmed for about 30 minutes. The perpendicular red light laser beam will be used to capture SBF and blood flow is measured in '"Flux" unit.
1 secondary outcome
balance
Time frame: at each of the nine visits( 90 minutes each visit: twice per week)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- 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. This study is not recruiting at the moment.
Everett Lohman, DSc principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive vibration and no passive vibration in people with Diabetic Neuropathies, run by Loma Linda University at 1 site in United States.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Feb 2019. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Skin blood flow (time frame: Change between Baseline and Week Nine Visit). 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 28 Feb 2019.