Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial
BackgroundSome patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-03-01
|
| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1069434/full |
| _version_ | 1811162536680095744 |
|---|---|
| author | Jan D. Wandrey Joanna Kastelik Thomas Fritzsche Claudia Denke Michael Schäfer Sascha Tafelski |
| author_facet | Jan D. Wandrey Joanna Kastelik Thomas Fritzsche Claudia Denke Michael Schäfer Sascha Tafelski |
| author_sort | Jan D. Wandrey |
| collection | DOAJ |
| description | BackgroundSome patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due to neuro-modulatory effects.MethodsThis controlled clinical pilot trial randomized patients to receive anodal, cathodal or sham-tDCS stimulation prior to local anesthetic infiltration. Pain attenuation, quality-of-life and side effects were assessed and compared with historic controls to estimate effects of tDCS stimulation setting.ResultsAltogether, 17 patients were randomized into three groups with different stimulation protocols. Relative reduction of pain intensity in per protocol treated patients were median 73%, 50% and 69% in anodal, cathodal and sham group, respectively (p = 0.726). Compared with a historic control group, a lower rate of responders with 50% reduction of pain intensity indicates probable placebo effects (OR 3.41 stimulation vs. non-stimulation setting, NNT 3.63). 76.9% (n = 10) of tDCS patients reported mild side-effects. Of all initially included 17 patients, 23.5% (n = 4) withdrew their study participation with highest proportion in the cathodal group (n = 3). A sample size calculation for a confirmatory trial revealed 120 patients using conservative estimations.DiscussionThis pilot trial does not support series of anodal tDCS as neuro-modulatory treatment to enhance pain alleviation of local anesthetic infiltration series. Notably, results may indicate placebo effects of tDCS settings. Feasibility of studies in this population was limited due to relevant drop-out rates. Anodal tDCS warrants further confirmation as neuro-modulatory pain treatment option. |
| first_indexed | 2024-04-10T06:32:23Z |
| format | Article |
| id | doaj.art-dcca5e0762bf42168ec3b2e5bca09856 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-04-10T06:32:23Z |
| publishDate | 2023-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-dcca5e0762bf42168ec3b2e5bca098562023-03-01T07:30:19ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-03-011410.3389/fneur.2023.10694341069434Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trialJan D. WandreyJoanna KastelikThomas FritzscheClaudia DenkeMichael SchäferSascha TafelskiBackgroundSome patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due to neuro-modulatory effects.MethodsThis controlled clinical pilot trial randomized patients to receive anodal, cathodal or sham-tDCS stimulation prior to local anesthetic infiltration. Pain attenuation, quality-of-life and side effects were assessed and compared with historic controls to estimate effects of tDCS stimulation setting.ResultsAltogether, 17 patients were randomized into three groups with different stimulation protocols. Relative reduction of pain intensity in per protocol treated patients were median 73%, 50% and 69% in anodal, cathodal and sham group, respectively (p = 0.726). Compared with a historic control group, a lower rate of responders with 50% reduction of pain intensity indicates probable placebo effects (OR 3.41 stimulation vs. non-stimulation setting, NNT 3.63). 76.9% (n = 10) of tDCS patients reported mild side-effects. Of all initially included 17 patients, 23.5% (n = 4) withdrew their study participation with highest proportion in the cathodal group (n = 3). A sample size calculation for a confirmatory trial revealed 120 patients using conservative estimations.DiscussionThis pilot trial does not support series of anodal tDCS as neuro-modulatory treatment to enhance pain alleviation of local anesthetic infiltration series. Notably, results may indicate placebo effects of tDCS settings. Feasibility of studies in this population was limited due to relevant drop-out rates. Anodal tDCS warrants further confirmation as neuro-modulatory pain treatment option.https://www.frontiersin.org/articles/10.3389/fneur.2023.1069434/fulltDCSchronic painneuropathic paincraniocephalic paininfiltration series |
| spellingShingle | Jan D. Wandrey Joanna Kastelik Thomas Fritzsche Claudia Denke Michael Schäfer Sascha Tafelski Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial Frontiers in Neurology tDCS chronic pain neuropathic pain craniocephalic pain infiltration series |
| title | Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial |
| title_full | Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial |
| title_fullStr | Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial |
| title_full_unstemmed | Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial |
| title_short | Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial |
| title_sort | supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain a randomized controlled pilot trial |
| topic | tDCS chronic pain neuropathic pain craniocephalic pain infiltration series |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1069434/full |
| work_keys_str_mv | AT jandwandrey supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial AT joannakastelik supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial AT thomasfritzsche supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial AT claudiadenke supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial AT michaelschafer supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial AT saschatafelski supplementingtranscranialdirectcurrentstimulationtolocalinfiltrationseriesforrefractoryneuropathiccraniocephalicpainarandomizedcontrolledpilottrial |