What a 6-Week Clinical Trial Found About Whole-Body Red Light Therapy for Fibromyalgia

Why Did Researchers Test Whole-Body Photobiomodulation for Fibromyalgia?

Fibromyalgia is a complex, long-term condition associated with widespread pain and a range of other symptoms, including fatigue, sleep disturbance, mood changes, stiffness, and cognitive difficulties. Because symptoms can affect several areas of health at once, researchers have continued to investigate treatment approaches that may be practical for people experiencing more than localized pain.

Photobiomodulation therapy, or PBMT, uses low-energy red and near-infrared light. It is sometimes referred to more generally as red light therapy. Earlier PBMT research had often focused on treating a particular body area with a smaller applicator. The researchers behind the featured study wanted to explore whether a whole-body approach could be delivered to people with fibromyalgia and whether it might influence several symptom domains at the same time.

The study was primarily a feasibility trial. In plain English, a feasibility study asks whether a treatment protocol can be organized, tolerated, and completed, and whether the results justify a larger study. It may provide early evidence of potential benefit, but it cannot establish treatment effectiveness on its own.

Who Took Part in the Study?

The researchers screened 49 people. Of those, 21 entered the trial and 19 completed the intervention. Participants had fibromyalgia, and the study used non-probability sampling rather than recruiting a large, randomly selected population.

The small number of participants is important. Results from 19 completers can help researchers identify whether a protocol is workable and whether a larger trial is warranted, but they cannot reliably represent everyone with fibromyalgia.

The clinical-trial record described the broader study as a single-center, single-arm investigation of whole-body PBM for chronic pain, with feasibility as its main purpose. The peer-reviewed publication reported the fibromyalgia findings.

How Was the Fibromyalgia Light Therapy Trial Designed?

This was an open-label, single-arm feasibility study. Every participant received the intervention, and there was no placebo, sham-treatment, usual-care, or untreated comparison group. Participants completed 18 whole-body PBMT sessions over approximately six weeks, with treatment scheduled three times per week.

The researchers used a NovoTHOR whole-body photobiomodulation system. The device delivered both visible red light at 660 nanometers and near-infrared light at 850 nanometers. The exposure was increased gradually during the first sessions:

The planned fluence was approximately 25 J/cm². This was the protocol used in this particular feasibility study; it should not be presented as a generally established or recommended dose for fibromyalgia. Device design, wavelength, irradiance, treatment distance, exposure time, and treatment schedule can all affect how a PBMT intervention is delivered.

What Did Researchers Measure?

The primary outcome was the Revised Fibromyalgia Impact Questionnaire, commonly abbreviated as the FIQR. The FIQR is designed to assess the overall impact of fibromyalgia on daily life and functioning. Lower scores indicate less overall fibromyalgia impact.

The researchers also assessed multiple symptoms and related outcomes, including pain intensity, pain interference, fatigue, sleep disturbance, stiffness, tenderness, anxiety, depression, cognitive symptoms, fibromyalgia severity, and participants’ overall impressions of change. The study included both participant-reported measures and performance-based cognitive measures.

This broad assessment was consistent with the multisymptom nature of fibromyalgia. It also means that the results should be read outcome by outcome rather than reduced to a single claim that the treatment “worked.”

What Did the Study Find After Six Weeks?

The largest reported change involved the FIQR. The mean score decreased from approximately 79.7 at baseline to 55.3 at week six, representing a mean improvement of about 24.44 points. The study reported a statistically significant difference, with p ≤ 0.001, and a large effect size for this outcome.

Pain measures also improved. Mean pain intensity decreased from approximately 7.08 to 3.93, while pain interference decreased from approximately 6.59 to 4.17. These were participant-reported outcomes, so they reflect how participants experienced and rated their symptoms rather than an objective measurement of pain biology.

The study also reported improvements in several additional outcomes:

The difference between self-reported and performance-based cognitive outcomes is worth noting. Participants reported fewer cognitive difficulties, but the objective cognitive test did not show an equally strong pattern. This illustrates why clinical studies often use several measures and why a positive change on one measure does not necessarily establish improvement across every aspect of a symptom.

Did the Improvements Last After Treatment Ended?

The researchers conducted a follow-up assessment at 24 weeks. The FIQR score remained statistically significantly lower than baseline, with an approximately 14-point improvement and a reported p value of 0.001.

However, the week-24 FIQR score was higher than the week-six score. In other words, some of the improvement observed immediately after the six-week treatment period had diminished by the later follow-up, even though the average score remained better than baseline.

The most accurate interpretation is that improvement was still present at 24 weeks compared with baseline in this small study, but the results do not establish that benefits lasted unchanged for six months. The study did not include a control group, so the follow-up findings cannot determine whether PBMT itself produced the longer-term difference.

How Did Participants Describe Their Experience?

The study included a qualitative component using participant-reported experience measures and semi-structured interviews. This allowed the researchers to examine acceptability, the experience of attending treatment sessions, perceived changes, and the practical feasibility of completing the schedule.

For a feasibility study, this information matters. A treatment may appear promising in theory but be difficult to deliver, uncomfortable, time-consuming, or unacceptable to participants. The researchers reported that the device and trial processes were acceptable and that participants were able to complete the treatment schedule.

These observations describe the study experience; they should not be treated as testimonials or as proof that other people will experience the same effects.

Was Whole-Body Photobiomodulation Well Tolerated?

The researchers reported that the intervention was well tolerated in this small study and that the treatment protocol was feasible and acceptable to participants.

That is more precise than saying whole-body red light therapy has been proven safe. A study with 19 treatment completers is too small to identify every possible adverse effect or to determine how the intervention would perform in people with different medical conditions, medications, or risk factors. Anyone considering light-based treatment should discuss it with an appropriate healthcare professional, especially when they have a significant medical condition, are pregnant, take photosensitizing medicines, or have concerns about light exposure.

What Can This Study Actually Tell Us?

The study provides preliminary evidence that a whole-body PBMT protocol can be delivered to people with fibromyalgia, that participants can attend a schedule of 18 sessions over approximately six weeks, and that the intervention was acceptable within the study setting. It also found improvements across several symptom and quality-of-life measures, which supports further investigation.

It does not prove that PBMT caused the improvements. The design had several limitations:

•There was no control or sham-treatment group.

•The sample was small, with only 19 participants completing treatment.

•The study was not randomized.

•Participants knew they were receiving the intervention.

•Several outcomes were self-reported and may be influenced by expectations, recall, or changes in how symptoms are perceived.

•Fibromyalgia symptoms can vary naturally over time.

•Participants may have experienced other changes during the six-week period that contributed to the results.

•The study assessed many outcomes, increasing the possibility that some apparent changes could occur by chance.

For these reasons, the findings are best described as encouraging but preliminary. Statistical significance within a single-arm study does not have the same meaning as a statistically significant difference between a treatment group and a well-matched control group.

Why Do Researchers Need a Larger Trial?

A larger randomized controlled trial could answer questions that this feasibility study could not. For example, it could test whether whole-body PBMT performs better than a credible sham treatment, estimate the size of any treatment effect, identify which symptoms respond most consistently, and examine how long any improvement lasts.

Future research could also compare treatment parameters, including exposure schedules and light delivery settings, and investigate whether particular patient characteristics are associated with better or poorer responses. The authors concluded that the feasibility findings supported progression toward a full-scale trial.

How Does This Research Relate to At-Home Red Light Therapy?

The study used a specific whole-body device, a defined combination of wavelengths, a particular exposure schedule, and a clinical research environment. Its findings cannot be directly translated into a claim that a particular home-use device will produce the same results.

At-home red and near-infrared light devices can differ substantially in coverage area, irradiance, wavelength configuration, treatment distance, session duration, and instructions. A consumer device should not be described as validated by this trial unless it has been studied under comparable conditions. Treatment settings should follow the manufacturer’s instructions, and people with fibromyalgia should seek individualized medical guidance rather than using this study as a substitute for care.

Clinical Takeaway

This small feasibility study found encouraging improvements in pain, fatigue, sleep, quality of life, and other fibromyalgia-related outcomes after approximately six weeks of whole-body photobiomodulation. Some improvement in the primary FIQR outcome remained at 24 weeks compared with baseline. However, because there was no control group and only 19 participants completed treatment, the findings cannot establish that PBMT caused those improvements. Larger randomized controlled trials are needed.

For broader background, readers can explore research on red light therapy for fibromyalgia and what photobiomodulation is. The study-specific findings should remain distinct from general claims about red light therapy or from claims about any particular home device.

References

[1] Fitzmaurice et al. (2023 ), Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial, Behavioral Sciences

[2] ClinicalTrials.gov, NCT05069363, Whole-Body Photobiomodulation and Chronic Pain Trial

[3] PubMed record for Fitzmaurice et al. (2023 )