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)
Study at a glance
AI-extracted from the abstract| 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 points | 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.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |
Citations in the library
Cites 37
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- A randomized controlled trial of mindfulness meditation versus relaxation training: Effects on distress, positive states of mind, rumination, and distraction Annals of Behavioral Medicine February 1, 2007
- Mindfulness Meditation and Psychopathology Annual Review of Clinical Psychology December 11, 2018
- Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: Results of a randomized clinical trial Arthritis Care & Research January 31, 2007
- Mindfulness-Based Stress Reduction as a Stress Management Intervention for Healthy Individuals Journal of Evidence-Based Complementary & Alternative Medicine July 22, 2014
and 32 more in the library