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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38404

Enrollment

Registered

2007-01-17

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic neuropatic pain in patients with diabetes

Interventions

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 g

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: age

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)