Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial

Thibaut, Aurore; Carvalho, Sandra; Morse, Leslie R.; Zafonte, Ross; Fregni, Felipe

doi:10.1016/j.neulet.2017.08.024

Cited by 27 publications

(53 citation statements)

References 65 publications

(89 reference statements)

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“…In fact, it has been shown recently that the response to tDCS in fibromyalgia was achieved in 50% of participants only after 15 sessions [11]. In fact, in our study, in which we tested the effects of M1 tDCS in participants with neuropathic pain following SCI, we showed that a delayed treatment response at 1-week follow-up (after 5 consecutive days of stimulationphase 1) and 4-weeks delayed response after additional 15 days of stimulation (phase 2) [12]. Therefore, the need to have longer periods of treatment together with limitation of transportation of people with SCI pose several potential problems to subject retention, a challenge reflected in trial dropout rates.…”

Section: Introductionsupporting

confidence: 46%

“…Moreover, usually the reasons for dropouts are treatment related; either because the participants were randomized to the active treatment group and experienced adverse side effects, or to the control group and experienced lack of efficacy [13]. The results from this exploratory study show that tDCS had a delayed pain decrease at 1-week follow-up for phase 1 and only at 4-week follow-up for phase II [12]. This delayed response to intervention may potentially explain the loss to follow-up in this trial, since participants may perceived this intervention as not working as expected or they believed they were receiving sham tDCS.…”

Section: Discussionmentioning

confidence: 80%

“…This study is one of the first studies testing the effectiveness of tDCS for chronic neuropathic pain in people with SCI with long follow-ups (that showed to be important given our efficacy results please see ref. [12]. And as such, a placebo intervention (i.e., sham tDCS) was chosen as comparator in order to increase the validity of the results, especially due to the 15 sessions timeframe that has been shown to induce a clinical meaningful effect in terms of pain relief.…”

Section: Discussionmentioning

confidence: 99%

“…The data presented in this study is the adherence of people with SCI to a long-term clinical trial (SCIMS trial; clin-icalTrials.gov Identifier: NCT01599767), which primary objective was to assess the efficacy of tDCS on pain relief. For more details about the effectiveness of tDCS on pain relief please see Thibaut et al [12].…”

Section: Methodsmentioning

confidence: 99%

“…Therefore, in this article, we present adherence data, such as time for dropout, from one longitudinal clinical trial that was designed to assess the efficacy of repetitive sessions of active vs. sham tDCS on pain relief in participant with chronic neuropathic pain secondary to SCI [12]. Since meta-analysis have shown significantly higher dropout rates in the placebo arm as compared to the active arm [14], here we are interested in analysing the data in an exploratory manner comparing active vs. sham group.…”

Section: Introductionmentioning

confidence: 99%

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Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury

et al. 2017

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Despite all the measures to improve study adherence (such as providing parking, flexibility to schedule sessions, follow-up with participants by phone), it seems that long follow-up periods may increase the likelihood of dropout. Given the need to understand long-term effects of interventions, longitudinal trials need to consider alternative designs or methods of treatment (for instance home treatment or home assessment) to decrease attrition rate.

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Section: Introductionsupporting

confidence: 46%

Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury

et al. 2017

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Non-invasive brain stimulation techniques for chronic pain

O’Connell

Marston

Spencer

et al. 2018

Cochrane Database of Systematic Reviews

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Non-invasive brain stimulation techniques for chronic pain

O’Connell

Marston

Spencer

et al. 2018

Cochrane Database of Systematic Reviews

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Background This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non‐invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic stimulation (rTMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), transcranial random noise stimulation (tRNS) and reduced impedance non‐invasive cortical electrostimulation (RINCE). Objectives To evaluate the efficacy of non‐invasive cortical stimulation techniques in the treatment of chronic pain. Search methods For this update we searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, LILACS and clinical trials registers from July 2013 to October 2017. Selection criteria Randomised and quasi‐randomised studies of rTMS, CES, tDCS, RINCE and tRNS if they employed a sham stimulation control group, recruited patients over the age of 18 years with pain of three months' duration or more, and measured pain as an outcome. Outcomes of interest were pain intensity measured using visual analogue scales or numerical rating scales, disability, quality of life and adverse events. Data collection and analysis Two review authors independently extracted and verified data. Where possible we entered data into meta‐analyses, excluding studies judged as high risk of bias. We used the GRADE system to assess the quality of evidence for core comparisons, and created three 'Summary of findings' tables. Main results We included an additional 38 trials (involving 1225 randomised participants) in this update, making a total of 94 trials in the review (involving 2983 randomised participants). This update included a total of 42 rTMS studies, 11 CES, 36 tDCS, two RINCE and two tRNS. One study evaluated both rTMS and tDCS. We judged only four studies as low risk of bias across all key criteria. Using the GRADE criteria we judged the quality of evidence for each outcome, and for all comparisons as low or very low; in large part this was due to issues of blinding and of precision. rTMS Meta‐analysis of rTMS studies versus sham for pain intensity at short‐term follow‐up (0 to < 1 week postintervention), (27 studies, involving 655 participants), demonstrated a small effect with heterogeneity (standardised mean difference (SMD) ‐0.22, 95% confidence interval (CI) ‐0.29 to ‐0.16, low‐quality evidence). This equates to a 7% (95% CI 5% to 9%) reduction in pain, or a 0.40 (95% CI 0.53 to 0.32) point reduction on a 0 to 10 pain intensity scale, which does not meet the minimum clinically important difference threshold of 15% or greater. Pre‐specified subgroup analyses did not find a difference between low‐frequency stimulation (low‐quality evidence) and rTMS appli...

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Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial

Cited by 27 publications

References 65 publications

Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury

Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury

Non-invasive brain stimulation techniques for chronic pain

Non-invasive brain stimulation techniques for chronic pain

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