Actively Recruiting

Age: 18Years +
All Genders
NCT05411523

Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy

Led by Mayo Clinic · Updated on 2026-02-02

20

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study examines how spinal cord stimulation (SCS) affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve problem and one of the potential side effects of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. CIPN usually begins in the hands or feet and gets worse over time. SCS is a type of therapy that has proven to be effective in treating numerous non-malignant pain disorders including failed back surgery syndrome, refractory angina, limb ischemia, complex regional pain syndrome, and diabetic peripheral neuropathy. SCS may also be useful in patients with CIPN. This study evaluates how SCS affects pain and quality of life in patients undergoing spinal cord stimulation for CIPN.

CONDITIONS

Official Title

Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older with a clinical diagnosis of chemotherapy-induced peripheral neuropathy for more than six months after stopping chemotherapy
  • Average pain intensity of 5 or higher on an 11-point numeric rating scale in the lower extremities at enrollment
  • Have tried and failed conventional medication management with at least two neuropathic pain medications
  • Have electrophysiological evidence of length-dependent peripheral neuropathy
  • Completed a 10-kHz spinal cord stimulator trial for CIPN with at least 75% pain reduction
  • Stable neurological status
  • On a stable pain medication regimen
  • Suitable candidate for surgical procedures required by this study
  • Able to read and understand English questionnaires and provide informed consent in English
  • Willing and able to complete all study procedures and visits
Not Eligible

You will not qualify if you...

  • Patient refusal to participate in the study
  • Presence of lower limb mononeuropathy
  • History of lower limb amputation or ulceration
  • Presence of another painful condition unrelated to CIPN and not treated in this study
  • Body mass index (BMI) of 40 or higher
  • Omeprazole dose over 120 mg
  • Progressive neurological diseases such as multiple sclerosis or severe spinal conditions
  • Certain comorbidities including coagulation or bleeding disorders and severe cardiac or pulmonary disease
  • Receiving other interventional procedures unrelated to spinal cord stimulation for limb pain
  • Active metastatic or untreated local malignant neoplasm unless deemed in remission
  • Life expectancy less than one year
  • Untreated addiction or dependency to medications, alcohol, or illicit drugs
  • Active, disruptive, or unstable psychological or psychiatric disorders

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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