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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR842 |
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Date of registration:
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14/12/2006 |
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Primary sponsor: |
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Public title:
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An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain.
(SCS 001)
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Scientific title:
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An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain.
(SCS 001) - SCS 001 |
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Date of first enrolment:
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1/8/2006 |
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Target sample size:
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45 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=842 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Factorial; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C.C.
Vos, de |
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Address:
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Medisch Spectrum Twente, Department of Neurosurgery,
P.O. Box 50000
7500 KA
Enschede
The Netherlands |
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Telephone:
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+31 (0)53 4873532 |
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Email:
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c.devos@ziekenhuis-mst.nl |
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Affiliation:
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Name:
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C.C.
Vos, de |
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Address:
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Medisch Spectrum Twente, Department of Neurosurgery,
P.O. Box 50000
7500 KA
Enschede
The Netherlands |
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Telephone:
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+31 (0)53 4873532 |
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Email:
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c.devos@ziekenhuis-mst.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Chronic, diabetic, peripheral neuropathic pain that exists for more than one year;
2. Patient cannot be treated further otherwise according to patients? medical specialist;
3. The pain-sensation on a VAS-scale is minimal 5 (recording both for day and night time).
Exclusion criteria: 1. Age < 18 years;
2. Psychological problems;
3. Neuropathic pain in upper extremities.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diabetic neuropathy
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Intervention(s)
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After a baseline period patients will be randomized to either the best medical practice with adjunctive SCS therapy arm or the best emdical practice without adjunctive SCS therapy arm. The control group will be followed simultanously with the SCS-treatment group.
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Primary Outcome(s)
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VAS score.
Measured at baseline and 1, 3, 6,
9 and 12 months after inclusion.
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Secondary Outcome(s)
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1. Response rates (greater than or equal to 50% reduction in pain intensity) at all visits;
2. Percent of patients that are pain free (>75% reduction in pain intensity) at all visits;
3. Mean and median percent change in pain intensity at all visits;
4. Pain free time during day and night.
5. McGill Pain Questionnaire;
6. Short Form 36;
7. Changes in pain medication;
8. Compliance rates.
9. Emergent adverse events;
10. Device complications;
11. Premature study withdrawal.
Measured at baseline and 1, 3, 6,
9 and 12 months after inclusion.
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Secondary ID(s)
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001
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ISRCTN03269533
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Source(s) of Monetary Support
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Medisch Spectrum Twente, Enschede, Stichting TWIN
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