Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - active treatment | Experimental |
| |
| Group B - conservative management | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulation by implanted device. | Device | Spinal cord stimulation (SCS) protocol from the implanted device. This involves activation of the device for the (SCS) protocol including Burst DR therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ganesan Baranidharan, MBBS, FRCA, FCARCSI | Contact | 0113 2063131 | g.baranidharan@nhs.net |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain and Interventional Neuromodulation Research Group | Recruiting | Leeds | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34854473 | Derived | O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided