ArticleJournal of pain research2021
Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial.
Article in Journal of pain research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03714425 (Efficacy of the Quell Wearable Device for Fibromyalgia), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of the Quell Wearable Device for Fibromyalgia
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- SIMFER guidelines on physical modalities for chronic primary pain management.European journal of physical and rehabilitation medicine · 2026Guideline
- Transcutaneous electrical nerve stimulation for fibromyalgia-like syndrome in patients with Long-COVID: a pilot randomized clinical trial.Scientific reports · 2024Trial
- Influence of Transcutaneous Electrical Nerve Stimulation (TENS) on Pressure Pain Thresholds and Conditioned Pain Modulation in a Randomized Controlled Trial in Women With Fibromyalgia.The journal of pain · 2024Trial
- Daily perceived change among patients with chronic pain: influence of sociodemographic, clinical, and psychological characteristics.Pain reports · 2026Article
- Digital Health Approaches to Geriatric Rehabilitation: A Narrative Paper.Annals of rehabilitation medicine · 2026Article
- Designing a Digital Twin for the Management of Noncommunicable Diseases: Protocol for a Pilot Study and Methodology Validation.JMIR research protocols · 2026Article
- Quantitative Sensory Testing in Fibromyalgia Syndrome: A Scoping Review.Biomedicines · 2025Review
- Physical Modalities for the Treatment of Pain in Patients with Fibromyalgia.Mediterranean journal of rheumatology · 2025Review
- Why is low educational attainment linked to worse pain and function in fibromyalgia?The journal of pain · 2025Observational
- Comparative Efficacy of Neuromodulation and Structured Exercise Program on Autonomic Modulation in Fibromyalgia Patients: Pilot Study.Journal of clinical medicine · 2024Article
- Comparative efficacy of neuromodulation and structured exercise program on pain and muscle oxygenation in fibromyalgia patients: a randomized crossover study.Frontiers in physiology · 2024Article
- Optimizing and Accelerating the Development of Precision Pain Treatments for Chronic Pain: IMMPACT Review and Recommendations.The journal of pain · 2023Review
- A transcutaneous electrical nerve stimulation device for the relief of neuropathic pain in NMOSD: A randomized, double-blind, sham-controlled trial.Multiple sclerosis journal - experimental, translational and clinicalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia. PATIENTS AND
methodsAdults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model.
resultsNo differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [-0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (-7.47, 95% CI [-12.46, -2.48], p=0.003), FIQR pain item (-0.62, 95% CI [-1.17, -0.06], p=0.029), BPI Interference (-0.70, 95% CI [-1.30, -0.11], p=0.021) and PDQ (-1.69, 95% CI [-3.20, -0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups.
conclusionThis study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia. CLINICALTRIALSGOV REGISTRATION: NCT03714425.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.