TENS for Peripheral Neuropathy

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Summary

This trial will test a wireless device called Transcutaneous Electrical Nerve Stimulation (TENS) to help with nerve damage caused by chemotherapy. Participants will be randomly divided into two groups - one will

Who is the study for?

This trial is for individuals experiencing nerve pain due to chemotherapy (CIPN). Participants must meet certain criteria and agree to the study's terms. Specific inclusion and exclusion details are not provided, but typically involve health status and treatment history.

What is being tested?

The study tests wireless TENS devices at two different doses: high-dose (Intervention group) versus low-dose (Placebo group). Patients will use these devices over an 8-week period with follow-up assessments focused on pain relief, nerve function, quality of life, gait, and balance.

What are the potential side effects?

While specific side effects are not listed for TENS therapy in this summary, common ones may include skin irritation where pads are placed, muscle twitching during use, or discomfort from the electrical current.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain level at 8 weeks from baseline

Secondary study objectives

Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline

Change in vibration perception threshold at 8 weeks from baseline

Changes in Quality of Life at 8 weeks from baseline

Other study objectives

Changes in Range of Motion (RoM) at 8 weeks from baseline

Changes in cadence at 8 weeks from baseline

Changes in double-support phase at 8 weeks from baseline

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention GroupActive Control1 Intervention

The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

Group II: Placebo GroupPlacebo Group1 Intervention

The placebo group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

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