The studies were generally well designed and did not approach pain intensity only but also how it influenced the affective dimension of pain, as well as physical and emotional function. Sixty-eight percent of studies contemplated ≥5/6 IMMPACT items (Tables 4–6; supplementary file 5 [S5], available at http://links.lww.com/PR9/A35). The item most frequently neglected was “self-perception of improvement.” PEDro classification for rTMS studies ranged from 3 to 9/10 (supplementary file 6 [S6], available at http://links.lww.com/PR9/A35). The major problems concerned blinding, especially of the therapist, and allocation concealment. Blinding the therapist to rTMS is virtually impossible, except for certain devices (TMS coils delivering active or placebo stimuli without an operator's knowledge), developed with this aim. However, many alternatives to patients' blinding are available and should be incorporated in the studies, the same for allocation concealment. Also, the use of a formal blinding assessment questionnaire is highly recommended and could overcome these potential biases as mentioned above for tDCS.
Based on the data methodological steps above, the consensus panel provided specific recommendations for NIBS for CP. Details are shown in Boxes 1 and 2.
According to these results, this consensus made a level A recommendation for efficacy of induction sessions (n = 5–10) of anodal tDCS, with 2-mA intensity over M1 (C3 and C4 of the 10/20 EEG international system or neuronavigated), with the cathode over the contralateral supraorbital area (Fp1 or Fp2 of the 10/20 EEG international system). Transcranial DCS might be used as an add-on analgesic treatment of patients who remain symptomatic, despite pharmacological and nonpharmacological treatment. These results are in agreement with previous reviews,45,59,70,119 and include not only the control of pain, but also increase in many aspects of quality of life, as well. A recent guideline60 made a level B recommendation for the use of anodal M1 tDCS, and this discrepancy is apparently due to the fact that they considered that trials coming from the same research group would be counted as one study. However, if we had followed the same criteria, we would again have 2 level II trials, which would increase the recommendation from level B to level A. It is important to highlight that although we input the higher level of recommendation to the use of tDCS in this condition, clinicians would expect only low (20%–30%) to moderate (30%–50%) pain intensity reduction.
Regarding the position of the anode over the motor cortex, a location on the hemisphere contralateral to pain should be recommended for unilateral pain (C3 or C4). If pain is bilateral or diffuse, one may consider positioning the anode over the dominant hemisphere or contralateral to the worst pain. For axial or lower limbs pain, a reasonable position for the active electrode should be at the vertex (Cz). However, there is no study comparing these montages, which are being recommended based only on neuroanatomical characteristics of the M1.
The present estimation of the relationship between benefits and harms was based on the IMMPACT recommendations, which is a potential flaw of previous studies. Benefit was expressed in terms of percentage of pain relief in the active vs sham groups. Although our classification took into account a comparison between high (>50%), moderate (>30%), or small (<30%) pain relief in the active and control groups, we considered to only assume this difference if it was statistically different. This method could have a potential limitation because it did not take into account the net difference between the active and sham arms. For example, 2 studies with >50% pain reduction in the active arms, but one with sham effect <10% and the other with sham effect >30% would be both considered as “high benefit” given this difference was statistically different, and both would be scored as having a “high” treatment effect. However, considering the induction period, this type of situation only occurred for one study,77 where real rTMS caused significant >50% pain relief compared with sham, but the sham arm provided >30% pain relief. Except for this case, all other rTMS studies (n = 9) and all tDCS studies (n = 9) included in the present analysis provided sham effects that were <30% pain relief compared with baseline suggesting that the scoring system we used was minimally influenced by this potential classification bias. In fact, several reviews have shown that different from intuitive thinking, NIBS techniques have relatively low placebo effects in pain and depression trials.
Harm was assessed independently but scored together with benefits in our classification according to IMMPACT-based approach, which may also be another limitation. None of the included studies presented serious harmful effects for the participants, except a case of seizure, which is discussed below. This study did not involve an accurate reliability study of the benefits, but this aspect was indirectly approached through the regional experts' opinions, which also included availability of equipment and trained staff. In most of the tDCS and rTMS studies, adverse events had statistically equal frequency after active and sham sessions. Some tDCS studies did report adverse events in active groups.78,83,94,104,113 Only 2 rTMS1,50 and one tDCS studies failed to mention adverse events. In one tDCS study, it was not possible to state whether the adverse events were in the active or sham group.42 Treatments with tDCS were generally safe and well-tolerated, and there were no severe adverse events reported. The most frequent adverse events were itching, tingling, and skin redness. Somnolence, concentration issues, fatigue, light headedness, headache, and one little burning below the cathode were also reported,83 but participants nevertheless completed the studies. The use of rTMS is commonly associated with higher risks, but these were not seen in the results of the revised studies. Headache and neck pain can happen in around 30% of the patients and might be managed by properly positioning in the stimulation chair. A checklist of potential contraindications is available91 and should be used in the screening to rTMS utilization.
This consensus work supports the use of NIBS neuromodulation for therapeutic purpose in patients with various CP syndromes using both tDCS and rTMS. For a detailed description on the recommendations of the infrastructure necessary to an NIBS facility, please refer to supplementary file 1 (S1), available at http://links.lww.com/PR9/A35.
The cost of the devices, including maintenance, and the necessity of skilled supervision during treatment increase the requirements to set up neuromodulation clinical facilities. One can estimate approximately 40 minutes to perform a tDCS session, and up to 1 hour to perform an rTMS session, which will lead to approximately 10 to 15 patients/day using a single machine. As there is need of 5 to 10 daily sessions for each patient during the induction phase of treatment, this drastically reduces the number of patients that can be allocated to the practice of NIBS in a given center, unless several machines and a proper staff number are available. Regulatory policies are another issue in NIBS neuromodulation, regardless the amount of clinical and scientific evidence provided in this area57,60,82 because most countries have not so far officially regulated its use for pain relief.34
This is the first regional consensus recommendation for the use of NIBS techniques for pain relief in LA and Caribbean region. This is an updated guideline supporting the use of tDCS and rTMS for pain and recommendations based on gathered scientific knowledge behind the use of these techniques. Based on this work, level A recommendation (low to moderate benefit) was provided for the use of anodal tDCS over M1 in the control of pain in fibromyalgia, and level B (potential, but still uncertain benefit) recommendation for its use in peripheral neuropathic pain, abdominal pain, and migraine. Bifrontal (F3/F4) tDCS has also received a level B recommendation for the treatment of fibromyalgia, as well as M1 HD-tDCS. A level B recommendation has also been attributed to Oz/Cz tDCS for migraine and for secondary benefits such as improvement in quality of life, decrease in anxiety, and increase in pressure pain threshold. Regarding rTMS, level A recommendation (low to moderate benefit) was provided for HF rTMS over M1 for fibromyalgia and neuropathic pain, and a level B recommendation (potential, but still uncertain benefit) for myofascial or musculoskeletal pain, CRPS, and migraine. Level A recommendation against the use of M1 tDCS for LBP and a level B recommendation against the use of HF rTMS over the left DLPFC in the control of CP were also recommended.
There are some limitations to this study. First, we did not perform a meta-analysis. Instead, we used guidelines to classify the evidence of studies. As yet, the number of studies is still low. In future, when number of studies has increased, a meta-analysis may be considered as part of our work to address our research question. Second, as in previous studies, studies with at least 25 participants receiving active treatment were classified as sufficiently statistically powered, considering previous recommendations. However, future studies or revision of this study may consider power calculations, instead. Classification of studies may also consider other instruments such as the GRADE system and also the problem of publication bias.
The authors have no conflict of interest to declare.
The authors thank FEDELAT for its special contribution in joining this group of specialists and Mrs. Luana Bittencourt for her contribution in the final recommendations.
Part of this study was presented as a poster in the 2018 World Congress on Pain, at Boston, USA.
Supplemental digital content
Supplemental digital content associated with this article can be found online at http://links.lww.com/PR9/A35.
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