A Brief Mindfulness Intervention for Pain Management in Fibromyalgia: A Single-arm Open-Label Study.
Perianen Ramasawmy, Luise Charlotte Heim, Elisabeth Fechner, Samuel Enrico Schumann, Thuy Tien Mai, Oscar Moschner, Yong Jiang, Xue Guo, Azadeh Lesani, Frank Petzke, Andrea Antal, Olga-Lucia Gamboa Arana
Restorative Neurology and Neuroscience August 1, 2026 DOI: 10.1177/09226028251410014 (opens in new tab) via PubMed
Summary
AI-generated from the abstractA four-week mindfulness-based intervention tailored for fibromyalgia, including weekly online group meetings and daily practices, was tested in an open-label single-arm study with 46 patients. Pain intensity measured on a numerical rating scale decreased statistically, but only 15.3% of participants achieved clinically meaningful pain relief. Moderate improvement in quality of life occurred, with 45.6% clinical responders. Small-to-medium improvements were seen in affective pain, mindfulness, resilience, and a measure of GABABergic inhibition (long-interval intracortical inhibition). The authors conclude that the results are insufficient to draw firm conclusions about therapeutic efficacy due to the study design and lack of clinical significance despite statistical significance.
Study at a glance
| Characteristics | Open-label single-arm study Randomized Peer reviewed |
|---|---|
| Sample size | 46 |
| Population | Patients with fibromyalgia |
| Duration | Four-week intervention |
| Topics | Meditation |
| Keywords | Fibromyalgia Home-based therapy Transcranial magnetic stimulation |
| Key finding | The mindfulness-based intervention reduced pain intensity statistically but not clinically, with only 15.3% of participants achieving clinically meaningful pain relief. |
Abstract
In this open-label single-arm study, we tested the preliminary therapeutic effects of a four-week mindfullness-based intervention (MBI) tailored for fibromyalgia, including weekly online group meetings and daily mindfulness practices. Forty-six patients completed the intervention. The primary outcome was pain intensity scored on a numerical rating scale (NRS). Secondary outcomes included verbal fluency and self-reports of affective pain, quality of life, sleep quality, mood, emotion regulation, and psychological impairment. Transcranial magnetic stimulation was used to measure mindfulness-induced cortical excitability changes. Participants reported statistically reduced pain intensity post-training, with only 15.3% of the patients demonstrating clinically meaningful pain relief. A moderate improvement in quality of life, with only 45.6% clinical responders, were noted. Small-to-medium improvements in affective pain level, mindfulness level, and resilience as well as increase in long-interval intracortical inhibition-a measure of GABABergic inhibition-were observed. The study introduces a novel MBI tailored for fibromyalgia. Nonetheless, given the current study design and the lack of clinical significance of the findings despite statistical significance, the results are insufficient to draw firm conclusions regarding its potential therapeutic efficacy. Future sham-controlled randomized clinical trials are necessary to validate and expand upon these results.