Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Brief Summary: This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.


Options:
A: Inclusion Criteria:

* SCS candidate with the Specify 5-6-5 surgical lead
* Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
* Average low back pain is ≥ 5 as assessed by the baseline NPRS
* Average low back pain is greater than leg pain
* Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion Criteria:

* Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
* Most recent back surgery \< 6 months ago
* Low back pain only (no leg pain)
* Investigator suspects substance abuse that might confound the study results
* Radiographic evidence of instability requiring fusion
* Pain relieved completely by lying down
* Life expectancy of \< 24 months
* Subject is pregnant or planning to become pregnant during the course of the study
* Subject is unable to undergo study assessments or complete questionnaires independently
B: Inclusion Criteria:

* age 18-60, Rome II criteria, abdominal pain \>4 (0-10 VAS), stable symptoms for \>2 years

Exclusion Criteria:

* other gastrointestinal disease, somatic or psychiatric co-morbidity
C: Inclusion Criteria:

1. Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
2. Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
3. Have stable neurological status.
4. Be on a stable analgesic regimen.
5. Be 22 years of age or older at the time of enrollment.
6. Be an appropriate candidate for the surgical procedures required in this study.
7. 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.
8. Be willing and capable of giving informed consent.
9. Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

Exclusion Criteria:

1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
2. Have a BMI ≥ 40.
3. Currently prescribed a daily opioid dosage \> 120 mg morphine equivalents.
4. Have a medical condition or pain in other area(s), not intended to be treated in this study.
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 for performing the procedure.
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. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
10. Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
11. Have an existing drug pump and/or another active implantable device such as a pacemaker.
12. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guidelines in the Physician's Manual.
13. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
14. Have a life expectancy of less than one year.
15. Have a local infection at the anticipated surgical entry site or an active systemic infection.
16. 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.
17. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
18. Be concomitantly participating in another clinical study.
19. Be involved in an injury claim under current litigation.
20. Be a recipient of Social Security Disability Insurance (SSDI).
21. Have a pending or approved worker's compensation claim.
22. 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.
D: Inclusion Criteria:

* Moderate-to-severe PDP in the lower limbs

  * The pain intended to treat has been present for more than 12 months
  * Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories:
  * Amitriptylin or an other tricyclic antidepressant and/or
  * Pregabalin (Lyrica®) or Gabapentin (Neurontin®) and/or
  * Duloxetine (Cymbalta®) and/or
  * Tramadol or strong opioids Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Starting dosage was based on individual patient characteristics. Each drug was tried for at least 3 weeks and dose was raised once, if possible. By insufficient pain relief and/or unacceptable side-effects, the drug treatment was stopped. Patients reached a steady state in medication use and it is not allowed to increase dosage during the study.
* Mean pain intensity during daytime and/or night time should be 5 or higher measured on a numeric rating scale (NRS). Pain during daytime will be scored 3 times per day during for 4 days according to Jensen.
* Patient's age is between 18 and 75 years.

Exclusion Criteria:

* The patient has had neuromodulation therapy during the month before the intake
* Neuropathic pain is most prevalent in the upper limbs (NRS\>3)
* Neuropathy or chronic pain of other origin than diabetes mellitus (NRS\> 3)
* Addiction: drugs, alcohol (\> 5E / day) and/or medication

  * Drugs: cocaine, heroine, marihuana.
  * Alcohol: wine, beer, liquor (max 5E / day)
  * Medication: benzodiazepines.
* Insufficient cooperation from the patient (little motivation, understanding or communication)
* Blood clotting disorder, when using 2 or more different kinds of anti coagulation
* Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to \> prednisolone 10 mg, immunodepressive, etc.)
* Peripheral vascular disease without palpable peripheral pulses at both feet (inclusion is possible if pulses are absent, but ankle brachial index is between 0.7 and 1.2 in both feet)
* Active foot ulceration
* Life expectancy \< 1 year
* Pacemaker
* Local infection or other skin disorders at site of incision
* Psychiatric problems potentially interfering with cooperation in the study
* Pregnancy
* Severe cardiac or pulmonary failure (\> NYHA classification II)
* Unstable blood glucose control (change in HbA1c\>1,0% in three months prior to inclusion)

Answer: C