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Burst Spinal Cord Stimulation for Neuropathic Pain.

Primary Purpose

Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Department of Pain Management and Research
  • Uppsala University Hospital, Multidisciplinary Pain Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Burst SCS

Sham

Arm Description

In the active comparator the burst SCS system will be turned on according to randomisation. A treatment period is a 2-week period where the patient receives either active treatment or sham. Each patient will go through 6 treatment periods (in total 12 weeks). A treatment cycle is a 4-week period with two treatment periods, one of active treatment and one of sham. Each patient will go through three treatment cycles.

In the sham comparator the burst SCS system will be turned off according to randomisation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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.
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.
Insomnia
Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)
EQ-5D index values
EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.
EQ-5D self-rated health
VAS 0-100 scale.
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.
Patient blinding questionnaire
Does the patient think that the system has been turned on or off
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).
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.

Full Information

First Posted
November 6, 2018
Last Updated
August 29, 2023
Sponsor
Oslo University Hospital
Collaborators
Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03733886
Brief Title
Burst Spinal Cord Stimulation for Neuropathic Pain.
Official Title
A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Uppsala University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
N-of-1-study. Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Burst SCS
Arm Type
Active Comparator
Arm Description
In the active comparator the burst SCS system will be turned on according to randomisation. A treatment period is a 2-week period where the patient receives either active treatment or sham. Each patient will go through 6 treatment periods (in total 12 weeks). A treatment cycle is a 4-week period with two treatment periods, one of active treatment and one of sham. Each patient will go through three treatment cycles.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
In the sham comparator the burst SCS system will be turned off according to randomisation.
Intervention Type
Device
Intervention Name(s)
Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Intervention Description
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
Primary Outcome Measure Information:
Title
Usual pain intensity in lower extremity(ies)
Description
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.
Time Frame
Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary Outcome Measure Information:
Title
Highest pain intensity in lower extremity(ies)
Description
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
Time Frame
Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Title
Lowest pain intensity in lower extremity(ies)
Description
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
Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Title
Pain intensity in lower extremity(ies)"now"
Description
Numeric rating scale (0-10); evening pain intensity (day 7-13), with anchor points 0 = No pain and 10 = Worst imaginable pain
Time Frame
Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Title
Pain unpleasantness
Description
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
Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Title
Three individually chosen functions that are inhibited by the pain
Description
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
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)
Title
Insomnia
Description
Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)
Time Frame
Time Frame: Will be measured at the end of each 14-day treatment period
Title
EQ-5D index values
Description
EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.
Time Frame
Time Frame: Will be measured at the end of each 14-day treatment period
Title
EQ-5D self-rated health
Description
VAS 0-100 scale.
Time Frame
Time Frame: Will be measured at the end of each 14-day treatment period
Title
Patient impression of change
Description
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
Time Frame: Will be measured at the end of each 14-day treatment period
Title
Patient blinding questionnaire
Description
Does the patient think that the system has been turned on or off
Time Frame
Time Frame: Will be measured at the end of each 14-day treatment period
Title
Synptoms of anxiety and depression
Description
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
Time Frame: Will be measured at the end of each 14-day treatment period
Title
Usual pain intensity in lower back
Description
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.
Time Frame
Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Lundeland, PhD
Organizational Affiliation
Department of Pain Management and Research, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Department of Pain Management and Research
City
Oslo
Country
Norway
Facility Name
Uppsala University Hospital, Multidisciplinary Pain Center
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who fulfill institutional guidelines.
IPD Sharing Time Frame
All of the individual participant data collected during the trial will be available after deidentification, beginning 9 months and lasting 5 years after publication.
IPD Sharing Access Criteria
Applications must fulfill institutional guidelines and requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
34854473
Citation
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Results Reference
derived

Learn more about this trial

Burst Spinal Cord Stimulation for Neuropathic Pain.

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