What is the long-term clinical benefit of best medical practice with and without adjunctive SCS Therapy in patients with chronic diabetic neuropathic pain?
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate superiority over time in treatment of pain of best medical
practice with adjunctive SCS Therapy compared to best medical practice without
SCS Therapy in patients with chronic diabetic neuropathic pain as measured by
VAS score.
Secondary outcome
To evaluate the efficacy over time of best medical practice with adjunctive SCS
Therapy compared to best medical practice without SCS Therapy in patients with
chronic diabetic neuropathic pain as measured by:
• Response rates (greater than or equal to 50% reduction in pain
intensity) at all visits.
• Percent of patients that are pain free (>75% reduction in pain intensity) at
all visits.
• Mean and median percent change in pain intensity at all visits.
• Pain free time during day and night.
To compare the effects over time of best medical practice with adjunctive SCS
Therapy compared to best medical practice without SCS Therapy on the following
health outcome measures:
• McGill Pain Questionnaire
• EuroQoL 5D.
• Changes in pain medication.
• Compliance rates.
To evaluate over time the safety and tolerability of best medical practice with
adjunctive SCS Therapy using information on treatment emergent adverse events,
device complications, and premature study withdrawal.
Background summary
Spinal cord stimulation (SCS) is an established treatment for patients with
chronic intractable pain. Few studies to date have concentrated on the use of
SCS in peripheral neuropathy. Most studies involved sources of peripheral
neuropathic pain of mixed etiology, and therefore do not possess adequate
descriptions of the effectiveness of SCS for diabetic peripheral neuropathy
specifically. Recently, De Vos and co-workers carried out an SCS efficacy study
in eleven diabetic patients with chronic pain who did not respond to
conventional treatment. Neuropathic pain relief was assessed by visual analogue
scale (VAS). However, no direct comparison between SCS and standard use of
medication(s) has been made in a prospective, randomized, long-term study.
Study objective
What is the long-term clinical benefit of best medical practice with and
without adjunctive SCS Therapy in patients with chronic diabetic neuropathic
pain?
Study design
Open, Prospective, Randomized, Parallel-group, Comparative, Long-tern
Effectiveness Study
Intervention
After a baseline period patients will be randomized to either the best medical
practice with adjunctive SCS therapy arm or the best medical practice without
adjunctive SCS therapy arm. The control group will be followed simultanously
with the SCS-treatment group.
Study burden and risks
The risk associated with participation in the SCS-001 study is low. The
components of the spinal cord stimulation system to be used in this study will
be those commercially available and described in the protocol of the Dutch
Neuromodulation study group.
Da Vincilaan 11 - box F1
Zaventem 1935
BE
Da Vincilaan 11 - box F1
Zaventem 1935
BE
Listed location countries
Age
Inclusion criteria
chronic, peripheral diabetic neuropathic pain that exists for more than one year
patient cannot be treated further otherwise according to patient's medical specialist
pain sensation on a VAS scale is minimal 5 (recording both for night and day)
Exclusion criteria
age < 18 years
psychological problems
neuropathic pain in upper extremities
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13322.044.06 |