Neuromodulation: more than a placebo effect?

Kjær, Sophie Wohlert; Rice, Andrew S.C.; Wartolowska, Karolina; Vase, Lene

doi:10.1097/j.pain.0000000000001727

Cited by 23 publications

(15 citation statements)

References 51 publications

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“…Some neurobiological studies have shown that placebo analgesia mechanisms may be associated with endogenous opioids, dopamine, endocannabinoids, oxytocin, or vasopressin. [70][71][72][73] However, the analgesic effect of neuromodulation with LA is significantly superior to the placebo effect in this study.…”

Section: Discussioncontrasting

confidence: 59%

The Effectiveness of Laser Acupuncture for Treatment of Musculoskeletal Pain: A Meta-Analysis of Randomized Controlled Studies

Hung¹,

Lin²,

Chiu³

et al. 2021

JPR

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Objective To evaluate the treatment effectiveness of laser acupuncture (LA) in patients with musculoskeletal pain. Methods Major electronic databases, including Medline, PubMed, Embase, Cochrane Library, CINAHL, and Scopus were searched to identify double-blind, randomized controlled trials of LA in musculoskeletal disorders. The primary outcome was the treatment efficacy for pain. The secondary outcomes included the comparison of disability, functional impairment, and dropout rate between LA and sham treatment, as well as the effect of sham treatment for pain. The results from included studies were synthesized with the random effects model. Results In total, 20 articles comprising 568 patients receiving LA and 534 patients receiving sham treatment were included in the current study. Our analysis showed LA significantly reduced pain (g=0.88, 95% confidence interval [CI]=0.35 to 1.42, p=0.001), disability (g=0.68, 95% CI=0.29 to 1.08, p<0.001), and functional impairment (g=0.67, 95% CI=0.32 to 1.03, p<0.001). Through meta-regression analysis, we found these effects were not moderated by mean age, the percentage of females, or treatment duration. Additionally, there was no significant difference between the two groups in dropout rate (risk ratio=0.73, p=0.08), and the sham treatment significantly reduced only pain intensity (g=0.54, 95% CI=0.32 to 0.77, p<0.001). Conclusion Our findings supported that LA significantly reduced pain, disability, and functional impairment in patients with musculoskeletal disorders. Further researches are required to determine the optimal therapeutic parameters and the suitable patients for receiving LA. Protocol Registration CRD42020190919.

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Section: Discussioncontrasting

confidence: 59%

The Effectiveness of Laser Acupuncture for Treatment of Musculoskeletal Pain: A Meta-Analysis of Randomized Controlled Studies

Hung¹,

Lin²,

Chiu³

et al. 2021

JPR

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“…Considering the overall results, the improvement in QoL due to the intervention can be mainly attributed to a placebo effect rather than to the tDCS itself. In outcomes such as pain, the magnitude of change in the placebo arm is large and long-lasting (explaining about 80% of the improvement in the active arm) [ 81 ]. In pain conditions, placebo has been positively related to large sample sizes (by the motivation and expectations of being part of a rigorous, professional and well-funded study) and with long duration trials (by a positive feedback mechanism: initially perceived pain relief leads to increased analgesia throughout the trial) [ 64 ].…”

Section: Discussionmentioning

confidence: 99%

Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia

et al. 2022

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Purpose Fibromyalgia (FM) is a chronic pain syndrome with a strong impact on quality of life (QoL). Treatment of this condition remains a challenge, due to the scarce evidence for the effectiveness of the therapeutic approaches available. Current attention is focused on transcranial direct current stimulation (tDCS), which has yielded promising results for pain treatment. Rather than focusing only on pain relief, in this study, we aimed to determine how active or sham tDCS (over three cortical targets -the primary motor cortex, the dorsolateral prefrontal cortex and the operculo-insular cortex-) affect QoL in patients with FM. Methods Using a double-blind, placebo-controlled design, we applied fifteen tDCS sessions of 20’ to initial 130 participants (randomized to any of the four treatment groups). We evaluated the QoL (assessed by SF-36) and the symptoms’ impact (assessed by FIQ-R) in baseline, after treatment and at 6 months follow-up. Results All groups were comparable as regards age, medication pattern and severity of symptoms before the treatment. We found that QoL and symptoms’ impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months. However, we did not observe any group effect nor group*treatment interaction. Conclusions After the intervention, we observed a non-specific effect that may be due to placebo, favoured by the expectations of tDCS efficacy and psychosocial variables inherent to the intervention (daily relationship with therapists and other patients in the clinic). Therefore, active tDCS is not superior to sham stimulation in improving QoL in FM.

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“…Patient selection could have been further strengthened by the inclusion of neuropathic pain specific screening questionnaires. The development and use of a true sham intervention with some perceivable but in-efficient stimulation parameters is a further strength—the lack of credible sham intervention has previously been noted as a limitation in neuromodulation trials [ 41 , 42 ]. The study achieved a high level of patient adherence resulting in high data quality reducing uncertainty, and active and comparator groups were well balanced.…”

Section: Discussionmentioning

confidence: 99%

Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

et al. 2021

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Background Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain. Methods (1) Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 min/day). The primary outcome was average pain intensity (0–10 Likert scale) recorded over 1 week, at 3 months, compared between study groups. (2) On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS. Results (1) 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0.3 units lower in active group (95% CI − 1.0, 0.3; p = 0.30) giving an effect size of 0.19 (Cohen’s D). Two non-device related serious adverse events were reported. (2) In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia. Conclusions Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Trial registration ISRCTN53432663.

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Neuromodulation: more than a placebo effect?

Cited by 23 publications

References 51 publications

The Effectiveness of Laser Acupuncture for Treatment of Musculoskeletal Pain: A Meta-Analysis of Randomized Controlled Studies

The Effectiveness of Laser Acupuncture for Treatment of Musculoskeletal Pain: A Meta-Analysis of Randomized Controlled Studies

Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia

Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

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