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Behavioural Intervention

Intervention Group for Pain

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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain level at 8 weeks from baseline
Secondary outcome measures
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 outcome measures
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.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,182 Total Patients Enrolled
8 Trials studying Pain
2,128 Patients Enrolled for Pain
NeuroMetrix, Inc.Industry Sponsor
6 Previous Clinical Trials
410 Total Patients Enrolled
1 Trials studying Pain
33 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing medical study?

"Affirmative. Information on clinicaltrials.gov highlights the ongoing patient recruitment for this trial. Initially posted on October 2, 2023, and last updated on March 15, 2024, the study aims to enroll 30 participants at a single site."

Answered by AI

What is the current number of participants being admitted into this research trial?

"Indeed, as detailed on clinicaltrials.gov, this trial is actively seeking participants. It was initially listed on October 2nd, 2023 and last revised on March 15th, 2024. The research aims to enroll a total of 30 patients at one designated site."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am looking for a treatment that can help with my numbness and pain from CIPN.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)
Bijan Najafi, PhD 2023. "Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06324344.
All > Paid Studies Houston > Paid Studies Pasadena
~20 spots leftby Oct 2025
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