Chronic Pain Clinical Trial
Official title:
A Sham-Controlled, Randomized Trial of Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis
Verified date | January 2024 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic pancreatitis leads to severe abdominal pain in up to 70% of patients, and several studies have proposed it has a neuropathic component. Current treatments often fail to provide adequate pain relief, necessitating new innovations for management. Spinal cord stimulation has been proposed to treat severe neuropathic pain refractory to conventional treatment, but sham-controlled trials have not previously been done in patients with visceral pain. This study will test the effect of spinal cord stimulation in chronic pancreatitis patients with insufficient pain relief from standard therapies.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Chronic pancreatitis according to the M-ANNHEIM criteria - Chronic abdominal pain (pain 3=3days per week in at least 3 months) - Pain insuficiently treated with patients ussual analgesic treatment - Patients with signs of obstruction of the pancreatic duct due to a stricture or stone have to undergo endoscopic or surgical decompression prior to enrolment Exclusion Criteria: - Patients suffering from painful conditions other than chronic pancreatitis that made them unable to distinguish the pain associated with chronic pancreatitis - Patients with ongoing alcohol abuse and illegal drug dependencies |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Gastroenterology, Aalborg University Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quantitative sensory testing: Pressure algometry | Pain detection and tolerance thresholds (kPa) | At baseline an immediately after the intervention | |
Other | Quantitative sensory testing: Repetitive pinprick stimulation | Difference in pain scores (VAS) between 1st and 10th stimulus | At baseline an immediately after the intervention | |
Other | Quantitative sensory testing: Cold pressor test | Cold pressor endurance time (seconds) | At baseline an immediately after the intervention | |
Other | Quantitative sensory testing: Conditioned pain modulation | Relative change in pressure tolerance threshold before and after cold pressor test (%) | At baseline an immediately after the intervention | |
Primary | Pain relief | The difference in pain intensity scores between active and sham stimulations measured using a patient pain diary based on a numeric rating scale where a score of "0" indicated no pain and a score of "10" indicated worst pain imaginable. Pain scores are registered daily for one week prior to intervention and during the two periods of active and sham SCS stimulations. | At baseline and days 7-10 in each stimulation period | |
Secondary | Patient Global Impression of Change (PGIC) | The Patient Global Impression of Change assessed after each stimulation period | Immediately after the intervention | |
Secondary | The modified Brief Pain Inventory short-form (mBPI-sf) | Differences in the pain and functioning composite scores of the modified Brief Pain Inventory short-form between stimulation period (SCS vs sham) | At baseline an immediately after the intervention | |
Secondary | Comprehensive Pain Assessment Tool short-form (COMPAT-sf) | Differences in the Comprehensive Pain Assessment Tool short-form (COMPAT-sf) total score and subscroes between stimulation periods (SCS vs sham) | At baseline an immediately after the intervention | |
Secondary | Quality of life using SF 36 (short form 36 health survey) | Differences in the SF 36 (short form 36 health survey) total score and subscores between stimulation periods (SCS vs sham) | At baseline an immediately after the intervention | |
Secondary | Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS) | Differences in the depression and anxiety scores of Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS) between stimulation periods (SCS vs sham) | At baseline an immediately after the intervention |
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