Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Randomised, Crossover, Controlled, Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS) as a Treatment for Persistent AbdomiNal RefrActory VisCEral PAin Secondary to Chronic Pancreatitis: PANACEA Trial
Brief Summary: To evaluate the effectiveness of Burst DR stimulation as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis. Abdominal pain is a main symptom in patients with chronic pancreatitis. Patients have a background constant pain with acute episodes needing admissions. Spinal cord stimulation (SCS) is a recognised treatment for neuropathic pain. This involves placing an electric wire in the spine and the use of electricity to manage the pain. This is a pacemaker for controlling pain. Burst DR stimulation delivers a wave form which mimics the way nerves conduct electrical signals, there are short bursts or spikes of stimulation followed by short periods of rest. The key aims and objectives of this study are to evaluate the efficacy of Burst DR SCS as a treatment for persistent pain secondary to chronic pancreatitis


Options:
A: Key Inclusion Criteria:

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
3. Qualifying pain score
4. Be on stable pain medications, as determined by the Investigator
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Key Exclusion Criteria:

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
5. Have any addictions as determined by the Investigator
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have prior experience with neuromodulation devices
8. Other general exclusions applicable for SCS devices
9. Be involved in an injury claim under current litigation
10. Have a pending or approved worker's compensation claim
B: Inclusion Criteria:

* Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
* Minimum pain intensity of 5/10 on the leg pain NRS at baseline
* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital

Exclusion Criteria:

* Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
* Abnormal pain behavior and/or unresolved psychiatric illness.
* Unresolved issues of secondary gain or inappropriate medication use.
C: Inclusion Criteria:

* Sub-acromial pain of at least 3 month (tendinopathy and partial tear only).
* Diagnosed by a Consultant of tendinopathic pain or partial thickness rotator cuff tear
* Has had an MRI or Ultrasound Scan to rule out alternative pathology
* Eligible for surgery.
* Completed a conservative management programme previously including:

  * physiotherapy that includes a remedial exercise regimen and
  * at least x1 cortisone injection but not more than 3 injections.

Exclusion Criteria:

* Full thickness tear of the rotator cuff tendons evident on MRI or Ultrasound imaging
* Undergone previous surgery on affected shoulder
* Have RA or other inflammatory disorder
* Symptomatic cervical spine pathology
* Previous septic arthritis
* History of radiotherapy on same side as affected shoulder
* Patients who have a strong preference for one treatment over another to an extent that they would not participate if allocated to their non- preferred group.
D: Inclusion Criteria:

* Male or female participants aged 18 years or older (no upper age limit) and willing to provide informed consent
* Participant is able and willing to comply with the follow-up schedule and protocol
* Participants diagnosed with persistent refractory visceral pain secondary to chronic pancreatitis for at least 6 months with or without dermal hyperalgesia or allodynia
* Minimum baseline pain score of 6 on eleven point NRS scale (0-10) for their visceral pain
* Previously tried and failed at least one conservative treatment for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for persistent pain
* Been deemed suitable for the study by the pancreatic or pain MDT
* Total daily dose of opioids equivalent to ≤120mg of Morphine or 50% reduction in opioid dose. If the patients are taking more than this dose, they will be offered a referral to our opioid reduction clinic to achieve the target opioid dose and the baseline opioid will be taken as the dose on referral
* In the investigators opinion, the patient is a suitable candidate for Spinal Cord Stimulation

Exclusion Criteria:

* Female participants of childbearing potential who are pregnant/nursing or plan to become pregnant during the course of the trial
* Escalating or changing pain condition within the past month as evidenced by investigator examination
* Sphlanchnectomy or radiofrequency treatment within the past 6 months
* Currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system
* In the investigators opinion has an active infection
* Participated in another clinical investigation within 30 days
* Medical co-morbidities that preclude surgical intervention
* Patient is incapable of understanding or operating the patient programmer handset
* Patient is morbidly obese (BMI ≥ 40)
* Participant has a current or previous condition, which will probably require MRI investigation sometime in the following 2 years
* Participant has had a spinal surgical procedure or has spinal pathology that would significantly impede lead implantation at the level planned for implantation
* Participant has another persistent painful condition other than persistent refractory visceral pain secondary to chronic pancreatitis.
* History of alcohol abuse in the last year or IV drug abuse in the last three years.
* No increases of more than 40% from baseline amylase and lipases

Answer: D