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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores non-drug treatments like heat, pressure, and vibration for individuals with diabetic peripheral neuropathy, a condition causing pain and numbness from diabetes-related nerve damage. The goal is to enhance quality of life and reduce reliance on pain medications such as opioids. Individuals with type 2 diabetes for at least five years and difficulties controlling blood sugar might be suitable candidates. Participants will undergo identical therapy sessions to assess the safety and effectiveness of these treatments in managing pain. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new, non-drug pain management options.

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 prior data suggests that this non-pharmacological intervention device is safe for diabetic neuropathy?

Research has shown that non-drug treatments like heat, pressure, and vibration are generally safe for people with diabetic nerve pain. One study with a small group found no side effects from whole-body vibration (WBV) therapy, suggesting it can safely and effectively manage pain without medication.

Although evidence indicates these treatments are well-tolerated, this study tests a new method. Safety in larger groups or over longer periods might differ. However, based on current knowledge, these therapies appear to have minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic neuropathy rely on medications like pain relievers, antidepressants, or anticonvulsants to manage symptoms. However, this new approach uses a combination of non-pharmacological methods: heat, pressure, and vibration. Researchers are excited about these treatments because they avoid the side effects often associated with drugs and can potentially offer relief in just a few sessions. By directly stimulating the nerves through these physical methods, this therapy could provide a safer, quicker alternative for pain management in diabetic neuropathy.

What evidence suggests that this non-pharmacological intervention device is effective for diabetic neuropathy?

Research has shown that treatments using heat, pressure, and vibration can ease pain from diabetic peripheral neuropathy (DPN). One study found that participants experienced a 62.5% reduction in pain after just five sessions of vibration therapy. Another study demonstrated that whole body vibration significantly reduced pain for those with DPN. These treatments also slightly improved balance and blood sugar levels. Early evidence suggests these methods might provide relief without medication. Participants in this trial will receive a non-pharmacological intervention involving heat, pressure, and vibration to assess its safety and feasibility. ^{1 2 3 5 6}

Who Is on the Research Team?

Chad G Rose, PhD

Principal Investigator

Auburn University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8630268/

Local plantar vibration for the treatment of diabetic ... Results. There was a 62.5% reduction in pain severity after five sessions of treatment. Vibration threshold of both patient's feet and protective sensation of ...

2. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-11-2022-e6262

Non-Pharmacological Therapy for Diabetic Neuropathy Whole body vibration therapy (WBV) significantly reduced pain in participants with diabetic peripheral neuropathy (DPN), as measured by the visual analog pain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6146195/

Effects of whole body vibration in individuals with diabetic ... Very low-quality evidence suggests that WBV has a slight positive effect on glycemic control in patients with DPN, improving neuropathic pain and balance.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05580705

Effects of Vibration Therapy in Addition to Routine Physical ... The study is aimed to determine the effects of sole-foot vibration therapy on pain intensity, static and dynamic balance, functional status and satisfaction to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05414968?term=AREA%5BConditionSearch%5D(Peripheral%20neuropathy%20interventions)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=5

A Novel Non-Pharmacological Treatment of Diabetic ... The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05414968/a-novel-non-pharmacological-treatment-of-diabetic-neuropathy

A Novel Non-Pharmacological Treatment of Diabetic ... The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), ...