PANACEA Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS)

Pain Clinical Trial

— PANACEA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595241
• Other study ID #: PM15/126
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Ganesan Baranidharan, MBBS, FRCA, FCARCSI
• Phone: 0113 2063131
• Email: g.baranidharan[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Spinal cord stimulation by implanted device.
Spinal cord stimulation (SCS) protocol from the implanted device. This involves activation of the device for the (SCS) protocol including Burst DR therapy.

Locations

Country	Name	City	State
United Kingdom	Pain and Interventional Neuromodulation Research Group	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of EQ-5D5L Health questionnaire	Successful completion of EQ-5D5L Health questionnaire leading to a EQ-5D index score (=0.200) recorded	1 hour
Primary	Numeric Rating Scale (NRS) recording pain severity	Percentage of change in pain severity recorded on the Numeric Rating Scale (NRS) at four months compared with baseline in both the groups.	1 hour