ClinTrial Refer

Trial Acronym
CIPN

Registration Number
2022-09-975

Scientific Title
A Prospective Study using High Frequency (10kHz) Spinal Cord Stimulation in Patients with Chemotherapy-Induced Peripheral Neuropathic Pain

This study will investigate the use of 10kHz SCS in patients with chronic chemotherapy-induced peripheral neuropathy as diagnosed by a specialist pain physician. The device will be provided to the patient according to the patient’s health insurance policy. Implantation and use of SCS system will follow the Physician's Manual applicable to the relevant geographical region, supporting manuals and centres’ commercial practice

1. Have a clinical diagnosis of chemotherapy-induced peripheral neuropathy, in either upper or lower limb for at least 6 months following cessation of chemotherapy including either:
I. Taxol (Paclitaxel), or
II. Folfox (Oxaliplatin de Gramont), or
III. Docetaxel (Taxotere)
2. Deemed to be in remission from cancer as per their treating oncologist
3. Average pain intensity of ≥ 6 out of 10 cm on the VAS in the affected area at enrolment
4. Failed conventional medical management with at least one pain medication
5. Have stable neurological status.
6. Be on a stable analgesic regimen at time of enrolment
7. Be an adult aged over 18
8. Be an appropriate candidate for the surgical procedures required in this study based on the requirements of the investigative site and clinical judgment of the implanting physician
9. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
10. Be willing and capable of giving informed consent

1. Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 
2. Unable to understand the study, provide informed consent, and/or comply with the study requirements (i.e. attend follow-up visits) 
3. Currently receiving radiotherapy to the axial spine or to the area of neuropathic pain. 
4. Currently prescribed a daily opioid dosage > 120 mg morphine equivalents. 
5. Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury. 
6. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral
vascular disease or uncontrolled diabetes mellitus that presents excess risk
7. Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
8. Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
9. Have an existing drug pump and/or another active implantable device such as a pacemaker.
10. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with the device
11. Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm.
12. Have a life expectancy of less than one year.
13. Have a local infection at the anticipated surgical entry site or an active systemic infection.
14. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
15. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.

Sydney Pain Research Centre

Website URL

Link Name

Link URL

Sydney Pain Centre

https://sydneypaincentre.com/

Secondary IDs
2022-09-975

Study Type
Interventional

Intervention Code
Treatment - Devices

Phase
Not Applicable

Minimum Age
18

Maximum Age
99

Date Registered
03/10/2023

Date Closed
N/A

Status
Closed

Enrolment Type
By Self-Referral,By Specialist and/or Surgeon Referral,Primary Care or GP Referral

Mutation Status and Biomarker
N/A

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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