Non-Pharmacological Therapy for Diabetic Neuropathy

Overseen By Michael E Zabala, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Vascular disease, ABI 0.9 or less, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of individuals with diabetes, and reduce the prevalence of opiate prescription, sensation loss, falls, and deaths caused by DPN. To this end, the proposed study will investigate and determine the feasibility of the non-pharmacological intervention device. The feasibility study involves 16 participants, split evenly between pre-neuropathic diabetic and neuropathic diabetic participants. During the study, each group will receive the same 45-minute intervention on 10 days spread over no more than 14 days total. Feasibility will be determined by change in pain assessed before and after intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments, so it's possible you may not need to change your current medication routine.

What data supports the effectiveness of this treatment for diabetic neuropathy?

Research shows that whole body vibration therapy, which is similar to the non-pharmacological treatment being studied, has been effective in reducing pain and improving balance and quality of life in people with diabetic peripheral neuropathy. ^{1 2 3 4 5}

Is non-pharmacological therapy for diabetic neuropathy safe for humans?

The research does not provide specific safety data for non-pharmacological therapy for diabetic neuropathy, but whole body vibration therapy, a similar treatment, has been studied and used without reported safety concerns in humans. ^{2 3 5 6 7}

How does Non-pharmacological Heat, Pressure, and Vibration Therapy differ from other treatments for diabetic neuropathy?

This treatment is unique because it uses a combination of heat, pressure, and vibration without medication to relieve symptoms of diabetic neuropathy, offering an alternative for those who do not respond well to drugs. Unlike traditional drug therapies, it focuses on physical stimulation to improve pain and quality of life. ^{2 3 8 9 10}

Research Team

Chad G Rose, PhD

Principal Investigator

Auburn University

Eligibility Criteria

This trial is for people who have had type 2 diabetes for at least 5 years and can show lab histories of their blood sugar control. It's not suitable for those with other diseases like vascular disease or an ankle-brachial index (ABI) less than 0.9, which could affect the results.

Inclusion Criteria

We need to see your blood sugar test results from the past 1-5 years.

I have been diagnosed with type 2 diabetes for 5 years or more.

Exclusion Criteria

Your ankle-brachial index (ABI) is 0.9 or lower.

I do not have any diseases like vascular disease that could affect the study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measures of foot sensation and blood flow are taken using diagnostic tools and MRI

1 week

1 visit (in-person)

Treatment

Participants receive a 45-minute intervention on 10 days spread over no more than 14 days total

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in pain and foot sensation after treatment

4 weeks

Treatment Details

Interventions

• Non-pharmacological Heat, Pressure, and Vibration

Trial Overview The study tests a new device that uses heat, pressure, and vibration as a treatment to improve life quality in diabetic neuropathy patients. There will be two groups: one pre-neuropathic and one neuropathic diabetic group; both receive the same non-drug treatment over ten sessions.

Participant Groups

Group I: Pilot Feasibility Arm Experimental Treatment 1 Intervention

Each participant will receive the same 45-minute intervention on 10 days spread over no more than 14 days total. At the end of each session, pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale (DVPRS) to establish the safety and feasibility of the proposed intervention.

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Findings from Research

A 4-week study involving 30 participants with diabetic peripheral neuropathy showed that using a wearable foot compression device improved vibration perception and balance control, indicating potential benefits for neuropathic symptoms.

Participants also experienced enhanced gait performance across various walking tasks, suggesting that this device could help improve mobility in individuals with diabetic peripheral neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy. Kang, GE., Zahiri, M., Lepow, B., et al.[2020]

Whole body vibration therapy (WBV) significantly reduced pain in participants with diabetic peripheral neuropathy (DPN), as measured by the visual analog pain scale (VAS) and neuropathic pain scale (NPS), after three sessions per week for four weeks.

The study involved 8 participants and found no side effects, suggesting that WBV is a safe and effective non-invasive treatment option for managing pain associated with DPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration therapy for painful diabetic peripheral neuropathy: a pilot study. Kessler, NJ., Hong, J.[2022]

Whole body vibration (WBV) therapy significantly improves pain, neuropathy disability, balance, and quality of life in patients with painful diabetic peripheral neuropathy (PDPN) after six weeks of treatment, as shown in a study of 26 participants.

The study found that WBV therapy led to notable improvements in various measures, including pain ratings and vibration perception, compared to a control group receiving standard care, highlighting its potential as an effective adjunct therapy for PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. Jamal, A., Ahmad, I., Ahamed, N., et al.[2022]

Local vibration therapy applied to the feet significantly reduced pain severity in a patient with diabetic peripheral neuropathy (DPN) by 62.5% after five treatment sessions.

The treatment also improved protective sensation, normalized vibration thresholds, and enhanced blood flow and balance, as indicated by increased skin temperature and a six-point improvement in balance scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local plantar vibration for the treatment of diabetic neuropathy: a case report. Sabziparvar, M., Naghdi, S., Ansari, NN., et al.[2022]

In a study of 392 patients over 12 years, 19.9% developed abnormal vibration perception thresholds (VPT), indicating a progression of diabetic peripheral neuropathy, while over 80% maintained normal VPT despite average glycemic control.

The study found that combining VPT scores with thermal threshold tests can effectively identify diabetic patients at risk for developing neuropathy, suggesting a potential method for selecting candidates for preventive treatments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The natural history of diabetic peripheral neuropathy determined by a 12 year prospective study using vibration perception thresholds. Coppini, DV., Wellmer, A., Weng, C., et al.[2022]

In a study of 34 diabetic patients, it was found that as the severity of neuropathy increased, the thresholds for detecting vibration and thermal sensations also increased, indicating worsening nerve function.

Diabetic patients without clinical symptoms of neuropathy had significantly lower warm sensibility indices compared to non-diabetic controls, suggesting that measuring thermal sensitivity could help identify early nerve damage in diabetics even before symptoms appear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibratory and thermal thresholds in diabetics with and without clinical neuropathy. Jensen, TS., Bach, FW., Kastrup, J., et al.[2019]

A study of 60 dental professionals (30 dentists and 30 dental hygienists) revealed that those exposed to high-frequency vibrations from dental tools showed significant impairments in vibrotactile sensibility, strength, and motor performance compared to non-exposed groups.

The findings suggest that this slight neuropathy could negatively impact their work performance, highlighting the urgent need for the development of safer dental equipment to reduce vibration exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropathy in female dental personnel exposed to high frequency vibrations. Akesson, I., Lundborg, G., Horstmann, V., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced pain scores in patients with painful diabetic neuropathy compared to placebo, indicating its efficacy as a treatment option.

In contrast, treatment with electromagnetic fields did not show any significant improvement in pain relief compared to control groups, suggesting it may not be an effective intervention for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation and electromagnetic field use in patients with diabetic neuropathy: systematic review and meta-analysis. Stein, C., Eibel, B., Sbruzzi, G., et al.[2022]

Whole-body vibration training significantly improved vibration perception thresholds in type 2 diabetic patients with peripheral neuropathy, based on a study involving 59 participants over 6 weeks.

In contrast, the control group that only performed lower body training showed no significant changes in perception thresholds, indicating the specific benefits of whole-body vibration training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole-body vibration therapy on perception thresholds of type 2 diabetic patients with peripheral neuropathy: a randomized controlled trial. Lee, K.[2020]

Whole-body vibration (WBV) may have a slight positive effect on glycemic control, neuropathic pain, and balance in patients with diabetic peripheral neuropathy (DPN), based on a review of three studies involving 83 patients.

However, the evidence is considered very low quality due to a high risk of bias in most studies, indicating that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole body vibration in individuals with diabetic peripheral neuropathy: a systematic review. Robinson, CC., Barreto, RPG., Plentz, RDM.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Whole body vibration therapy for painful diabetic peripheral neuropathy: a pilot study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Local plantar vibration for the treatment of diabetic neuropathy: a case report. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

The natural history of diabetic peripheral neuropathy determined by a 12 year prospective study using vibration perception thresholds. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Vibratory and thermal thresholds in diabetics with and without clinical neuropathy. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Neuropathy in female dental personnel exposed to high frequency vibrations. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Electrical stimulation and electromagnetic field use in patients with diabetic neuropathy: systematic review and meta-analysis. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Effects of whole-body vibration therapy on perception thresholds of type 2 diabetic patients with peripheral neuropathy: a randomized controlled trial. [2020]

10. Greece pubmed.ncbi.nlm.nih.gov

Effects of whole body vibration in individuals with diabetic peripheral neuropathy: a systematic review. [2019]