Transcutaneous electrical nerve stimulation and pain with movement in people with fibromyalgia: a cluster randomized clinical trial 2026 Dailey et al

Andy

Andy

Senior Member (Voting rights)
Key Points

Question Is transcutaneous electrical nerve stimulation (TENS) effective for treating pain when combined with physical therapy (PT) in individuals with fibromyalgia?

Findings This cluster randomized clinical trial of 459 participants with fibromyalgia from 28 PT clinics from 6 health systems found that adding TENS to routine PT resulted in a statistically significant and clinically meaningful reduction of movement-evoked pain at 2 months, with effectiveness sustained for at least 6 months.

Meaning This study’s findings suggest that TENS is a safe and effective modality for managing fibromyalgia pain.

Importance Fibromyalgia is characterized by chronic widespread pain that is often exacerbated by movement that interferes with daily activities. Development of effective treatments for movement-evoked pain is essential for improving function for individuals with fibromyalgia.

Objective To evaluate whether the addition of transcutaneous electrical nerve stimulation (TENS) to outpatient physical therapy improves fibromyalgia-associated movement-evoked pain.

Design, Setting, and Participants The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study was a cluster-randomized clinical trial of participants with fibromyalgia at 28 outpatient PT clinics from 6 health care systems. Between February 1, 2021, and September 31, 2024, 958 participants were screened, 459 participants enrolled, and 384 completed baseline data collection, with final data collected in March 2025.

Intervention Clinics were randomized to PT plus TENS (PT-TENS) and PT-only groups. Data were captured on days 1, 30, 60 (primary end point, randomized phase), 90, and 180. Participants in the PT-only group received TENS after day 60 (extension phase). TENS was applied to the upper and lower back with instructions to use 2 hours daily with parameters of modulating frequency of 2 to 125 Hz for 100 to 180 microseconds at a strong but comfortable intensity.

Main Outcomes and Measures The primary outcome was a change in movement-evoked pain (scale of 0-10, with 0 indicating no pain and 10 indicating worst pain imaginable) from baseline to day 60 rated during a 5-times sit-and-stand task using a linear mixed-effects model. In addition, patient-reported improvement based on the Patient Global Impression of Change score and patient-reported adverse events were assessed.

Results A total of 384 FM-TIPS participants (mean [SD] age, 53 [15] years; 351 [91%] female) completed baseline data collection (modified intention-to-treat), with 191 individuals in PT-TENS group and 193 in PT-only group. Movement-evoked pain at day 60 during TENS treatment was significantly lower in the PT-TENS group compared with the PT-only group (group mean difference, −1.2; 95 CI, −1.6 to −0.7; d = 0.46). A dose-response effect for TENS was observed, with more participants in the PT-TENS group reporting improvement on the Patient Global Impression of Change (120 [72%] vs 86 [51%], P = .001) and a 30% or greater reduction in movement-evoked pain in responder analysis (66 of 161 [41%] vs 22 of 169 [13%]; P < .001). At day 180, 217 respondents (81%) found TENS helpful and 147 (55%) used TENS daily. There were no serious adverse events, and 109 of 358 (30%) experienced minor adverse events during the entire 6 months of the study.

Conclusions and Relevance In this cluster randomized clinical trial of TENS in fibromyalgia, TENS meaningfully reduced movement-evoked pain and remained effective for 6 months. This study’s results suggest that TENS is a safe, inexpensive, and readily available treatment for fibromyalgia.

Open access
 
Commentary: TENS vs Physical Therapy for Fibromyalgia—Not All Exercise Is Good Exercise

"Perhaps the most surprising aspect of this current study1 is the poor response individuals with fibromyalgia had to PT alone. Scores for the primary outcome, movement-evoked pain, showed almost no improvement, nor were there many appreciable changes across the secondary end points. These poor outcomes could perhaps be explained by the PT itself. The PT delivered in this study was not standardized—the approach to treatment was left to the discretion of each physical therapist. As recommended in most clinical guidelines, previous studies of PT and exercise in fibromyalgia have nearly all used exercise and PT regimens that were specifically tailored for fibromyalgia, often deploying a start low and go slow approach.4,5 The present study1 demonstrating no net improvement in pain in the group receiving PT in the community raises the possibility that when PT is performed by therapists not accustomed to caring for fibromyalgia, and not tailored specifically to patients with fibromyalgia, it may sometimes worsen rather than improve pain.

A recent qualitative study explored physical therapists’ understanding of and concerns about treating fibromyalgia.6 They found that many considered fibromyalgia to be an ambiguous illness driven by psychological factors. In addition, without specific training, most reported lacking the competence to reduce the pain of their patients. Uncertainty about the diagnosis and a sense of failure when trying to reduce pain levels led some therapists to deploy unorthodox treatment strategies that were most likely unhelpful. Certainly, education and training specific to fibromyalgia could improve treatment outcomes and therapists’ sense of mastery and success with these patients."
 
Is there any point in trying TENS for me/cfs related pain? I think it is/can be quite similar to the pain in fibromyalgia, but I am not sure!
 
This is why physios, psychologists and psychiatrists don’t run multi-arm trials with interventions that are believed in. It destroys the bias that is the suggestion of their stuff having efficacy. You will instead got an arm with "usual care" to just strengthen that bias.
 
But did they try wearing a clown hat? Maybe a red one? Or a blue? Oh, I know! A polka dot hat! Surely that's the magical bean.

Hadn't noticed this comic before, but damn does it perfectly describe biopsychosocial pseudoresearch:

(Direct link: https://xkcd.com/882/)
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The paper said:
Perhaps the most surprising aspect of this current study1 is the poor response individuals with fibromyalgia had to PT alone.
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Surprising to who? Dr Magoo? A deaf and blind head in a jar? No, really, are they actually pretending not to know that this has been controversial for decades? That no study has actually produced reliable evidence of this? This is either feigned surprise or they truly operate entirely within completely insulated bubbles. This is frankly like being taken by surprise at the fact that water is wet, as a marine scientist.
The present study1 demonstrating no net improvement in pain in the group receiving PT in the community raises the possibility that when PT is performed by therapists not accustomed to caring for fibromyalgia, and not tailored specifically to patients with fibromyalgia, it may sometimes worsen rather than improve pain.
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Exact same Big Lie as with GET. Always No True GET, even in trials with people 'specializing' in this. Who somehow need to be trained in doing something they are 'teaching' patients.

Why not blame the weather? Space weather, while we're at it? Illuminati? George Clooney's current facial hair?
 
Not enthused about the study itself. I do know that the stick on electrodes patches are not cheap..


What I use daily for my FM pain is a capsaicin cream (0.1% --Capzaisin is the brand I use) which works on light to moderate pain by blocking pain transmission.

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I don't understand the point of using TENS for all over body pain. I thought it was for localised pain.

I have come across it prescribed for period pain and it seemed to help a bit for a while but the woman trying it found she became oversensitised to the TENS induced sensation, so it was counterproductive.
 
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