The Pain Suppressive Effect of Low Frequency Spinal Cord Stimulation Versus High Frequency Spinal Cord Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 10
- Primary Endpoint
- Visual Analog Pain Scores (VAS)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Visual Analog Pain Scores (VAS)
Time Frame: 24 days
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
Secondary Outcomes
- Short Form-36(1 month, 12 months)
- Visual Analog Pain scores (VAS)(12 months)
- EuroQoL 5Dimensions-3Levels(1 month, 12 months)
- Sleep questionnaire(1 month, 12 months)
- (Serious) Adverse Events(12 months)
- GPES(1 month, 12 months)
- Employment status(12 months)
Investigators
Jennifer Breel
Study Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)