Dataset Information

Short-Term Effects of Whole-Body Photobiomodulation on Pain, Quality of Life and Psychological Factors in a Population Suffering from Fibromyalgia: A Triple-Blinded Randomised Clinical Trial.

ABSTRACT:

Background

Fibromyalgia (FM) is a multifunctional chronic musculoskeletal pain condition characterised by sensory hypersensitivity. Photobiomodulation (PBM) has shown a positive impact on relieving pain; however, no studies to our knowledge have analysed a whole-body PBM intervention in subjects with FM. The aims of the study were to compare the effects of whole-body PBM with placebo PBM on pain, functionality and psychological symptoms in patients suffering from FM.

Methods

Forty-two subjects were recruited from a private care practice. The design of the study is a randomised, triple-blinded, placebo-controlled clinical trial. Participants received 12 treatment sessions. Pain, quality of life, level of physical activity and psychological factors were assessed at baseline (T0), after session 6 (T1), after treatment (T2) and at 2-week (T3) follow-up.

Results

There were statistically significant differences in pain at 4 weeks (p ≤ 0.001) (T2) and the 2-week follow-up (T3) (p ≤ 0.001). In relation to the quality of life, there were statistically significant improvements after session 6 (p ≤ 0.001) (T1), immediately after treatment (p ≤ 0.001) (T2) and at the 2-week (T3) follow-up (p ≤ 0.001). Kinesiophobia presented significant differences between groups immediately after treatment (p ≤ 0.001) (T2) and at the 2-week (T3) follow-up (p ≤ 0.001), with self-efficacy only showing significant differences between groups 2 weeks after the treatment (p = 0.01) (T2). There were no differences between groups when comparing pain catastrophising at any time.

Conclusion

Whole-body PBM resulted in a significant reduction in pain and an improvement in quality of life in those participants suffering from FM after receiving 4 weeks of treatment. Furthermore, psychological factors such as kinesiophobia and self-efficacy were also improved. Thus, a whole-body PBM treatment is presented as a possible new multifactorial treatment with potential benefits for those with FM and more studies are needed to corroborate our findings.

Trial registration

ClinicalTrials.gov (NCT0424897).

SUBMITTER: Navarro-Ledesma S

PROVIDER: S-EPMC9845459 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Short-Term Effects of Whole-Body Photobiomodulation on Pain, Quality of Life and Psychological Factors in a Population Suffering from Fibromyalgia: A Triple-Blinded Randomised Clinical Trial.

Navarro-Ledesma Santiago S Carroll James J Burton Patricia P Ana González-Muñoz GM

Pain and therapy 20221111 1

<h4>Background</h4>Fibromyalgia (FM) is a multifunctional chronic musculoskeletal pain condition characterised by sensory hypersensitivity. Photobiomodulation (PBM) has shown a positive impact on relieving pain; however, no studies to our knowledge have analysed a whole-body PBM intervention in subjects with FM. The aims of the study were to compare the effects of whole-body PBM with placebo PBM on pain, functionality and psychological symptoms in patients suffering from FM.<h4>Methods</h4>Forty ...[more]

PMID: 36369323

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Project description:BackgroundThe development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging. The aim of this study is to investigate the impact of whole-body photobiomodulation (PBM) on pain perception, functionality, quality of soft tissue, central sensitisation and psychological factors in patients suffering with FMS.MethodsThis study is a randomised, placebo-controlled clinical trial. A total of 44 participants will be recruited in a private care practice and randomised to receive either a whole-body PBM therapy programme or placebo in the same care centre. The parameters of the PBM programme are as follows: wavelengths of red and near-infrared LEDs 50:50 ratio with 660-850 nanometers; fluence of 25.2 J/cm2; treatment time of 1200 s and a total power emitted of 967 W. Treatment sessions will be 3 times weekly for a period of 4 weeks, totalling 12 treatment sessions. Primary outcome will be pain (Numeric Pain Rating Scale; Widespread Pain Index; Symptom Severity Score). Secondary outcomes will be functionality (Fibromyalgia Impact Questionnaire; the Leisure Time Physical Activity Instrument), quality of soft tissue (elastography), central sensitisation (pain pressure threshold and the Autonomic Symptom Profile) and psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficacy questionnaire). Assessments will be at baseline (T1), after session 6 (T2), after treatment (T3) and 2 weeks (T4), 3 (T5) and 6 (T6) month follow-up.DiscussionPBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole-body treatment in FM is yet to be explored. This trial will investigate whether whole-body PBM therapy is effective at reducing pain intensity, improving functionality, quality of soft tissue, central sensitisation symptoms and psychological measurements. Furthermore, 3- and 6-month follow-up will investigate long-term efficacy of this treatment.Trial registrationNCT04248972. Registered on January 29, 2020, https://clinicaltrials.gov/ct2/show/NCT04248972?term=navarro-ledesma+santiago&draw=2&rank=2.

Project description:BackgroundThe management of fibromyalgia (FM) symptoms on a global scale remains a complex endeavor. This study endeavors to assess the impact of whole-body photobiomodulation (PBM) compared to placebo PBM on pain, functionality, and psychological symptoms in individuals afflicted with fibromyalgia.ObjectivesThe primary objectives of this research were to conduct a comparative analysis of the effects of whole-body photobiomodulation (PBM) and placebo PBM on pain, functionality, and psychological symptoms in patients suffering from fibromyalgia (FM).MethodsA total of 42 subjects were recruited from a private care practice for participation in this triple-blinded, placebo-controlled, randomized clinical trial. Participants underwent 12 treatment sessions, and assessments were conducted at various intervals, including baseline (T0), midway through the 12-session treatment (T1), at the completion of the 12 sessions (T2), and follow-ups at 2 weeks (T3), 3 months (T4), and 6 months (T5).ResultsStatistical analysis revealed significant reductions in pain at T2, T3, and T5. Additionally, quality of life exhibited marked improvements after sessions at T1, T2, T3, T4, and T5. Leisure activity also demonstrated statistically significant improvements at T2, T3, T4, and T5. Furthermore, kinesiophobia showed significant differences between groups immediately after treatment at T2, T3, T4, and T5. Self-efficacy, when compared between groups, demonstrated significant differences at T3, T4, and T5 (two weeks after treatment). Lastly, pain catastrophizing exhibited significant differences only at T5.ConclusionThe findings of this study indicate that whole-body PBM treatment for 4 weeks resulted in significant pain reduction and improved quality of life in individuals suffering from FM. Furthermore, kinesiophobia and self-efficacy demonstrated improvements in both short-term and long-term assessments, while pain catastrophizing showed improvement at the 6-month follow-up. Consequently, whole-body PBM emerges as a promising multifactorial treatment option for FM patients, though further studies are required to validate and strengthen these results.Clinical Trial Registration:Clinicaltrials.gov, NCT0424897.

Project description:BackgroundNo literature reviews have systematically identified and evaluated research on the psychological determinants of endurance performance, and sport psychology performance enhancement guidelines for endurance sports are not founded on a systematic appraisal of endurance-specific research.ObjectiveA systematic literature review was conducted to identify practical psychological interventions that improve endurance performance and to identify additional psychological factors that affect endurance performance. Additional objectives were to evaluate the research practices of the included studies, to suggest theoretical and applied implications, and to guide future research.MethodsElectronic databases, forward-citation searches and manual searches of reference lists were used to locate relevant studies. Peer-reviewed studies were included when they chose an experimental or quasi-experimental research design; a psychological manipulation; endurance performance as the dependent variable; and athletes or physically active, healthy adults as participants.ResultsConsistent support was found for using imagery, self-talk and goal setting to improve endurance performance, but it is unclear whether learning multiple psychological skills is more beneficial than learning one psychological skill. The results also demonstrated that mental fatigue undermines endurance performance, and verbal encouragement and head-to-head competition can have a beneficial effect. Interventions that influenced perception of effort consistently affected endurance performance.ConclusionsPsychological skills training could benefit an endurance athlete. Researchers are encouraged to compare different practical psychological interventions, to examine the effects of these interventions for athletes in competition and to include a placebo control condition or an alternative control treatment. Researchers are also encouraged to explore additional psychological factors that could have a negative effect on endurance performance. Future research should include psychological mediating variables and moderating variables. Implications for theoretical explanations for endurance performance and evidence-based practice are described.

Project description:IntroductionChronic pain conditions are a leading cause of disease and disability. They are associated with symptoms such as fatigue, sleep and mood disturbances. Minimal evidence is available to support effective treatments and alternatives treatment approaches are called for. Photobiomodulation therapy has been highlighted as one promising option. A whole-body therapy device (NovoTHOR) has recently been developed with a number of potential advantages for people with chronic pain. Research is needed to consider the feasibility of this device.Methods and analysisA single-centre single-armed (no placebo group) feasibility study with an embedded qualitative component will be conducted. The intervention will comprise 18 treatments over 6 weeks, with 6-month follow-up, in the whole-body photobiomodulation device. A non-probability sample of 20 adult participants with a clinician diagnosis of chronic axial pain, polyarthralgia, myofascial pain or widespread pain will be recruited (self-referral and clinician referral). Outcome measures will focus on acceptability of trial processes with a view to guiding a definitive randomised controlled trial. Analyses will use descriptive statistics for quantitative aspects. The qualitative element will be assessed by means of a participant-reported experience questionnaire postintervention and semistructured audio-recorded interviews at three stages; preintervention, midintervention and postintervention. The latter will be transcribed verbatim and a reflexive thematic analysis will be used to identify emerging themes. Exploratory outcomes (participant-reported and performance-based measures) will be analysed according to data distribution.Ethics and disseminationThe study has received ethical approval from the Leicester Central Research and Ethics Committee. Findings will be disseminated via local chronic pain groups, public register update, submission for presentation at scientific meetings and open-access peer-reviewed journals, and via academic social networks.Trial registration numberNCT05069363.

Project description:IntroductionThe role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm2 vs 3 J/cm2) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group.Methods and analysisA prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm2 of PBM, 3 J/cm2 of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators.Ethics and disseminationThis study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov NCT05106608.

Dataset Information

Short-Term Effects of Whole-Body Photobiomodulation on Pain, Quality of Life and Psychological Factors in a Population Suffering from Fibromyalgia: A Triple-Blinded Randomised Clinical Trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Short-Term Effects of Whole-Body Photobiomodulation on Pain, Quality of Life and Psychological Factors in a Population Suffering from Fibromyalgia: A Triple-Blinded Randomised Clinical Trial.

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