Evidence map›Paper›PMID 26303326›Full record

Trial reportBMC musculoskeletal disorders2015

Comparison of tonic spinal cord stimulation, high-frequency and burst stimulation in patients with complex regional pain syndrome: a double-blind, randomised placebo controlled trial.

N Kriek, J G Groeneweg, D L Stronks, F J P M Huygen

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02902796 (Randomized Controlled Cross Over Study to Compare the Efficacy of 1000 Hertz), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02902796 phase2 / phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

Randomized Controlled Cross Over Study to Compare the Efficacy of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Axial Pain Relief

TypeinterventionalSponsorThe Center for Clinical Research, Winston-Salem, NCRan2016 to 2019Enrolled20ConditionsChronic PainArmsSpinal cord stimulator
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Emerging Treatments for Neuropathic Pain.Current pain and headache reports · 2015
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

N KriekCenter for Pain Medicine, Erasmus University Medical Center, Postbox 2040, 3000 CA, Rotterdam, The Netherlands. n.kriek@erasmusmc.nl.
J G GroenewegCenter for Pain Medicine, Erasmus University Medical Center, Postbox 2040, 3000 CA, Rotterdam, The Netherlands. j.groeneweg@erasmusmc.nl.
D L StronksCenter for Pain Medicine, Erasmus University Medical Center, Postbox 2040, 3000 CA, Rotterdam, The Netherlands. d.stronks@erasmusmc.nl.
F J P M HuygenCenter for Pain Medicine, Erasmus University Medical Center, Postbox 2040, 3000 CA, Rotterdam, The Netherlands. f.huygen@erasmusmc.nl.
Erasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundComplex Regional Pain Syndrome (CRPS) is a disabling disease that is sometimes difficult to treat. Although spinal cord stimulation (SCS) can reduce pain in most patients with CRPS, some do not achieve the desired reduction in pain. Moreover, the pain reduction can diminish over time even after an initially successful period of SCS. Pain reduction can be regained by increasing the SCS frequency, but this has not been investigated in a prospective trial. This study compares pain reduction using five SCS frequencies (standard 40 Hz, 500 Hz, 1200 Hz, burst and placebo stimulation) in patients with CRPS to determine which of the modalities is most effective.

designAll patients with a confirmed CRPS diagnosis that have unsuccessfully tried all other therapies and are eligible for SCS, can enroll in this trial (primary implantation group). CRPS patients that already receive SCS therapy, or those previously treated with SCS but with loss of therapeutic effect over time, can also participate (re-implantation group). Once all inclusion criteria are met and written informed consent obtained, patients will undergo a baseline assessment (T0). A 2-week trial with SCS is performed and, if successful, a rechargeable internal pulse generator (IPG) is implanted. For the following 3 months the patient will have standard 40 Hz stimulation therapy before a follow-up assessment (T1) is performed. Those who have completed the T1 assessment will enroll in a 10-week crossover period in which the five SCS frequencies are tested in five periods, each frequency lasting for 2 weeks. At the end of the crossover period, the patient will choose which frequency is to be used for stimulation for an additional 3 months, until the T2 assessment. DISCUSSION: Currently no trials are available that systematically investigate the importance of variation in frequency during SCS in patients with CRPS. Data from this trial will provide better insight as to whether SCS with a higher frequency, or with burst stimulation, results in more effective pain relief.

trial registrationCurrent Controlled Trials ISRCTN36655259.

Indexed as

AbsenteeismAnalgesicsCombined Modality TherapyComplex Regional Pain SyndromesCross-Over StudiesDouble-Blind MethodHealth ExpendituresHumansMuscle Strength DynamometerPain MeasurementPain PerceptionPain ThresholdParesthesiaProspective StudiesSkin TemperatureSpinal Cord StimulationAnalgesics

Identifiers

PMID26303326
PMCPMC4547415
OpenAlexW1851168259

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.