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Failed Back Surgery SyndromeHALONCT02112474

The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies

A study testing Spinal Cord Stimulation, Group 1 and Group 2 in people with Failed Back Surgery Syndrome and Neuropathic Pain, run by Jennifer Breel at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used for decades. It is used most commonly in patients with chronic neuropathic leg pain, after spinal surgery. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Spinal Cord Stimulation, Group 1 and Group 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesNetherlands
Study dates
13 Nov 2014to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/female, 18 years to 70 years
  • Chronic, persistent, refractory, unilateral neuropathic limb pain, as a result of spinal surgery
  • Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain
  • Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months
  • Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area
  • Subject is able and willing to provide informed consent
  • Subject is able and willing to comply with the protocol and follow-up schedule
  • Subject has been included for implantation according to standard criteria from the Dutch Neuromodulation Society

Who cannot join

  • Back pain component of more than 20% or VAS > 40mm on 100mm scale
  • Bilateral limb pain
  • Subjects with a previous SCS implantation.
  • Changes in pain medication in the 2 months preceding the trial period;
  • Expected inability of subjects to correctly operate the neurostimulation system
  • Presence of any other clinically significant or disabling chronic pain condition -eg. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc.
Show all 13Show fewer
  • History of coagulation disorders, lupus erythematosus, diabetes mellitus, or morbus Bechterew
  • Symptoms or proof of any malignant disease
  • Current use of medicines affecting coagulation which cannot be temporarily stopped
  • Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
  • Life expectancy of less than 1 year
  • Existing or planned pregnancy in the trial period
  • BMI >20 and <35 - a minimum and maximum BMI limit are imposed due to the technical difficulties and risk of complications in underweight or morbidly obese subjects.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • Medisch Centrum Alkmaar

    Alkmaar, North Holland, 1815 JD

  • Academic Medical Center

    Amsterdam, North Holland, 1105 AZ

  • Alrijne Hospital

    Leiderdorp, South Holland, 2353 GA

  • Rijnstate Hospital

    Velp, Gelderland, 883 AZ

  • Diakonessenhuis

    Zeist, Utrecht, 3700 BA

Other trials in Netherlands

About this study

Official title: The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation

Electrical stimulation of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used for decades. It is used most commonly in patients with chronic neuropathic leg pain, after spinal surgery. Conventional neurostimulation is applied in frequencies of 30 to 60 Hertz (Hz) and perceptible paraesthesias are felt. Stimulation using higher frequencies with sub perception paraesthesias has recently challenged the conventional form of neurostimulation.The high frequency stimulation appears to show better pain relief for both back and limb pain in comparison to low frequency SCS, and may also to be effective in some subjects who did not respond to low frequency SCS.

Read the detailed description

Rationale:

Electrical stimulation of the dorsal columns of the spinal cord (Spinal Cord Stimulation or SCS) for pain relief has been used in humans for several decades. The most common indication for SCS is the treatment of refractory neuropathic leg pain, particularly when these symptoms persist after an anatomically successful operation (Failed Back Surgery Syndrome or FBSS).

Low frequency - conventional - SCS (LF-SCS) is applied in frequencies ranging from 30 to 60 Hertz (Hz) and the subject feels paraesthesias in the painful area, which is considered the ideal situation. Recently, LF-SCS has been challenged by the development of stimulation modes at higher frequencies which provide pain relief at sub-perception threshold, i.e. without paraesthesias. A recent case series reported that High Frequency Spinal Cord Stimulation (HF-SCS) appears to show better pain relief for both back and limb pain in comparison to LF-SCS, and also to be effective in some subjects who did not respond to LF-SCS.

Objective:

The primary objective of this trial is to compare pain suppression in two groups of subjects with chronic unilateral limb pain as a result of FBSS .

Study design:

A prospective, double blind (subject, physician, statistician), multi-centre, randomized, crossover trial of SCS in the treatment of subjects with refractory neuropathic leg pain after back surgery.

Study population:

Patients with chronic neuropathic refractory unilateral leg pain

Intervention:

Patients will undergo neurostimulation with low and high frequency parameters, the order in which they receive treatment will be randomized

Main study endpoint:

Pain suppression in the short and long-term (24 days and 12 months)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Both methods of stimulation are standard clinical practice performed routinely in the study centres, both groups will receive this standard care. The only difference is change of stimulation frequency and the order in which it is applied.

Possible benefit to the subject is that both forms of stimulation will be evaluated. This may lead to a better quality of life in the HF-SCS Group as result of pain relief without paraesthesias. Furthermore, non-responders to LF-SCS may benefit from HF-SCS.

Being tested
Spinal Cord Stimulation, Group 1, Group 2
Keywords
Failed Back Surgery Syndrome, Neuropathic pain, Leg Pain, Chronic Pain, Spinal Cord Stimulation, Neurostimulation
Medical subject headings
Failed Back Surgery Syndrome, Neuralgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord StimulationDevice

    Crossover design whereby subjects will undergo Spinal Cord Stimulation in two arms: low frequency stimulation and high frequency stimulation

  • Group 1Device

    9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias

  • Group 2Device

    9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias

Study groups in NCT02112474
Study groupRoleWhat they receive
Spinal Cord Stimulation Group 1Experimental9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias
Receives: Device: Spinal Cord Stimulation; Device: Group 1
Spinal Cord Stimulation Group 2Experimental9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias
Receives: Device: Spinal Cord Stimulation; Device: Group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Pain Scores (VAS)

    0mm to 10mm line scale, where higher score is better, measured 4 times a day at 09:00, 15:00, 21:00 and a nightscore measured first thing in the morning

    Measured: 24 days

Secondary outcomes (7)

  1. Visual Analog Pain scores (VAS)

    0mm to 10mm line scale, where higher score is better, measured 4 times a day at 09:00, 15:00, 21:00 and a nightscore measured first thing in the morning

    Measured: 12 months

  2. EuroQoL 5Dimensions-3Levels

    Quality of LIfe, 5 questions measured on 3 levels (mild =1, moderate=2, severe=3). Higher score is worse. Each domain calculated according to a national index.

    Measured: 1 month, 12 months

  3. Short Form-36

    Quality of Life, 36 questions with differing formats, 8 domains, higher score is better

    Measured: 1 month, 12 months

  4. Sleep questionnaire

    Quality of sleep before and after stimulation, Several Likert-type items 0-5 and 0-7, higher score is better

    Measured: 1 month, 12 months

  5. GPES

    Subject satisfaction,1 Likert-type item 0-7, higher score is better

    Measured: 1 month, 12 months

  6. Employment status

    Change in employment status, open question whether or not employment status has changed and how many hours per week persons were/not working

    Measured: 12 months

  7. (Serious) Adverse Events

    Number of patients with device related events such as lead dislocation, infections, pocket pain, increase in pain whilst using one paticular frequency etc.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2014 (estimated)
  2. Study start13 Nov 2014
  3. Primary completion17 Nov 2017
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112474
Sponsor's protocol ID
MDT-HF-2013
Other IDs
NL43067.018.13, 2013_281
Acronym
HALO
Status last verified
Nov 2020
First submitted
25 Mar 2014
Last updated
30 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Breel J, Wille F, Wensing AGCL, Kallewaard JW, Pelleboer H, Zuidema X, Burger K, de Graaf S, Hollmann MW. A Comparison of 1000 Hz to 30 Hz Spinal Cord Stimulation Strategies in Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome: A Multicenter, Randomized, Double-Blinded, Crossover Clinical Study (HALO). Pain Ther. 2021 Dec;10(2):1189-1202. doi: 10.1007/s40122-021-00268-7. Epub 2021 Jun 6.

    PubMed 34091818

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation, Group 1 and Group 2 in people with Failed Back Surgery Syndrome and Neuropathic Pain, run by Jennifer Breel at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Pain Scores (VAS) (time frame: 24 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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