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Trial record 1 of 1 for:    NCT03733886
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Burst Spinal Cord Stimulation for Neuropathic Pain.

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ClinicalTrials.gov Identifier: NCT03733886
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bård Lundeland, Oslo University Hospital

Brief Summary:
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of peripheral neuropathic pain in an extremity. It is a double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathic Pain Device: Burst SCS Not Applicable

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, function (Patient-Specific Functional Scale) and activity (accelerometry). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Burst SCS

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.

Device: Burst SCS
Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level.

Sham Comparator: Sham
In the sham comparator the burst SCS system will be turned off according to randomisation.
Device: Burst SCS
Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level.




Primary Outcome Measures :
  1. Usual pain intensity [ Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) ]
    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 :
  1. Highest pain intensity [ Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) ]
    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

  2. Lowest pain intensity [ 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) ]
    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

  3. Pain intensity "now" [ 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) ]
    Numeric rating scale (0-10); evening pain intensity (day 7-13), with anchor points 0 = No pain and 10 = Worst imaginable pain

  4. Pain 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) ]
    Numeric rating scale (0-10) of pain unpleasantness the last 24 hours, with anchor points 0 = no unpleasantness to 10 = worst imaginable unpleasantness.

  5. Three individually chosen functions that are inhibited by the pain [ 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) ]
    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.

  6. Physical activity levels [ 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) ]
    Accelerometry by ActiGraph; Activity Levels (Sedentary; Light; Moderate; Vigorous, Very vigorous); 7 days (day 7-13)

  7. Physical activity measured by metabolic equivalents [ 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) ]
    Accelerometry by ActiGraph (see section 3.8); METs (Metabolic Equivalents); 7 days (day 7-13). Continuous variable.

  8. Insomnia [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)

  9. EQ-5D index values [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.

  10. EQ-5D self-rated health [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    VAS 0-100 scale.

  11. Patient impression of change [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    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.

  12. Clinician impression of change [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    Clinician Global Impression of Change questionnaire. Clinician'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.

  13. Patient blinding questionnaire [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    s the patient think that the system has been turned on or off

  14. Synptoms of anxiety and depression [ Time Frame: Time Frame: Will be measured at the end of each 14-day treatment period ]
    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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History, symptoms and clinical findings consistent with peripheral neuropathic pain in an extremity ("probable" or "definite") for at least 3 months.
  • Understand Norwegian (written and spoken).
  • Average 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

Relative

  • Ongoing medication that affects coagulation or platelet function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733886


Contacts
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Contact: Bård Lundeland, PhD +4723026161 baalun@ous-hf.no
Contact: Audun Stubhaug, PhD +4723026161 astubhau@ous-hf.no

Locations
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Norway
Oslo University Hospital, Department of Pain Management and Research Recruiting
Oslo, Norway
Contact: Bård Lundeland, PhD       baalun@ous-hf.no   
Contact: Christopher Ekholdt, Msc         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Bård Lundeland, PhD Department of Pain Management and Research, Oslo University Hospital

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Responsible Party: Bård Lundeland, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03733886     History of Changes
Other Study ID Numbers: 2017/402/REK nord
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: Applications must fulfill institutional guidelines and requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms