Burst Spinal Cord Stimulation for Neuropathic Pain.

Radiculopathy Clinical Trial

Official title:

A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733886
• Other study ID #: 2017/402/REK nord
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: June 22, 2023

Study information

• Verified date: August 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.

Description:

SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.

Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.

In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.

• Understand Norwegian or Swedish language (written and spoken).

• Usual pain intensity = 3.5 / 10 (NRS 0-10)

Exclusion Criteria:

Absolute

• Opioid dose > 100 mg morphine equivalents / day

• Ongoing litigation

• Mental / psychiatric disorder that may affect treatment

• Chronic generalized pain

• Pregnancy

• Hypersensitivity to local anesthetics

• Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders

• Laminectomy in or above level for planned epidural access

• Spine surgery the last 3 months

Relative

• Ongoing medication that affects coagulation or platelet function

Related Conditions & MeSH terms

• Low Back Pain
• Lower Back Pain
• Neuralgia
• Peripheral Neuropathic Pain
• Radiculopathy

Intervention

Device:
• Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Pain Management and Research	Oslo
Sweden	Uppsala University Hospital, Multidisciplinary Pain Center	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Uppsala University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usual pain intensity in lower extremity(ies)	Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.	Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary	Highest pain intensity in lower extremity(ies)	Numeric rating scale (0-10); highest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain	Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary	Lowest pain intensity in lower extremity(ies)	Numeric rating scale (0-10); lowest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain	Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary	Pain intensity in lower extremity(ies)"now"	Numeric rating scale (0-10); evening pain intensity (day 7-13), with anchor points 0 = No pain and 10 = Worst imaginable pain	Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary	Pain unpleasantness	Numeric rating scale (0-10) of pain unpleasantness the last 24 hours, with anchor points 0 = no unpleasantness to 10 = worst imaginable unpleasantness.	Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary	Three individually chosen functions that are inhibited by the pain	The Patient-Specific Functional Scale (Numeric Rating Scale (0-10)) (day 7-13). Anchor points 0 = Unable to perform activity to 10 = Able to perform activity.	Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period)
Secondary	Insomnia	Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	EQ-5D index values	EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	EQ-5D self-rated health	VAS 0-100 scale.	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	Patient impression of change	Patient Global Impression of Change questionnaire. Patient's global impression of change (function, symptoms and quality of life) since last control (about 14 days prior): Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	Patient blinding questionnaire	Does the patient think that the system has been turned on or off	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	Synptoms of anxiety and depression	Hopkins Symptom Checklist-25. Likert scale, from 1(Not at all) to 4 (Extremely), mean of sumscore, 25 in total. Change in totalscore (Continious variable).	Time Frame: Will be measured at the end of each 14-day treatment period
Secondary	Usual pain intensity in lower back	Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.	Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)