Trial reportTrials2012
Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial.
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effect of photobiomodulation on pain and quality of life in fibromyalgia syndrome: a systematic review.Lasers in medical science · 2026Pooled it
- Effect of preemptive photobiomodulation associated with nimesulide on the postsurgical outcomes, oxidative stress, and quality of life after third molar surgery: a randomized, split-mouth, controlled clinical trial.Clinical oral investigations · 2022Trial
- Trial
- Low-level laser therapy to treat fibromyalgia.Lasers in medical science · 2014Trial
- Beyond the Pain: A Systematic Narrative Review of the Latest Advancements in Fibromyalgia Treatment.Cureus · 2023Review
- Whole-body photobiomodulation therapy for chronic pain: a protocol for a feasibility trial.BMJ open · 2022Article
- Pulsed Laser Acupuncture in the Treatment of Pain and Heart Rate Variability in Fibromyalgia Patients: A Pilot Randomized Clinical Trial.Journal of lasers in medical sciences · 2022Article
- Acute low-level laser therapy effects on peripheral muscle strength and resistance in patients with fibromyalgia.Lasers in medical science · 2020Article
- A Review of Low-Level Laser Therapy for Spinal Cord Injury: Challenges And Safety.Journal of lasers in medical sciences · 2020Review
- Effect of pre-operatory low-level laser therapy on pain, swelling, and trismus associated with third-molar surgery.Medicina oral, patologia oral y cirugia bucal · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLow-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep. METHODS/
designOne hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤ .05).
trial registrationThe protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-42gkzt).
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