The Pain Suppressive Effect of Alternative Spinal Cord Stimulation Frequencies
HALO
3 other identifiers
interventional
30
1 country
5
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedStudy Start
First participant enrolled
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedNovember 30, 2020
November 1, 2020
3 years
March 25, 2014
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
24 days
Secondary Outcomes (7)
Visual Analog Pain scores (VAS)
12 months
EuroQoL 5Dimensions-3Levels
1 month, 12 months
Short Form-36
1 month, 12 months
Sleep questionnaire
1 month, 12 months
GPES
1 month, 12 months
- +2 more secondary outcomes
Study Arms (2)
Spinal Cord Stimulation Group 1
EXPERIMENTAL9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias
Spinal Cord Stimulation Group 2
EXPERIMENTAL9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias
Interventions
Crossover design whereby subjects will undergo Spinal Cord Stimulation in two arms: low frequency stimulation and high frequency stimulation
9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias
9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jennifer Breellead
- Diakonessenhuis, Utrechtcollaborator
- Rijnstate Hospitalcollaborator
- Alrijne Hospitalcollaborator
- Noordwest Ziekenhuisgroepcollaborator
Study Sites (5)
Rijnstate Hospital
Velp, Gelderland, 883 AZ, Netherlands
Medisch Centrum Alkmaar
Alkmaar, North Holland, 1815 JD, Netherlands
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
Alrijne Hospital
Leiderdorp, South Holland, 2353 GA, Netherlands
Diakonessenhuis
Zeist, Utrecht, 3700 BA, Netherlands
Related Publications (1)
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.
PMID: 34091818DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Markus W Hollmann, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
Frank Wille, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
Jennifer S Breel, MPA,MSc.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study Investigator
Study Record Dates
First Submitted
March 25, 2014
First Posted
April 14, 2014
Study Start
November 13, 2014
Primary Completion
November 17, 2017
Study Completion
November 30, 2018
Last Updated
November 30, 2020
Record last verified: 2020-11