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PeerJ 2024(1) This trial will compare the clinical and psychosocial effectiveness of in-group and individually pain neuroscience education (PNE) in patients with chronic low back... (Randomized Controlled Trial)
Randomized Controlled Trial
Effectiveness of in-group individually administered pain neuroscience education on clinical and psychosocial outcomes in patients with chronic low back pain: randomized controlled study protocol.
OBJECTIVE
(1) This trial will compare the clinical and psychosocial effectiveness of in-group and individually pain neuroscience education (PNE) in patients with chronic low back pain (CLBP). In addition, (2) the influence of social determinants of health on post-treatment results will be analyzed.
METHODS
A three-arm randomized controlled trial will be conducted. Sixty-nine participants with CLBP will be recruited in a 1:1:1 ratio. Participants, assessor, and statistician will be blinded to group assignment. The PNE intervention will be adapted to the context of the participants. An experimental group ( = 33) will receive PNE in an in-group modality, the other experimental group ( = 33) will receive PNE in an individually modality and the control group ( = 33) will continue with usual care. Additionally, participants will be encouraged to stay active by walking for 20-30 min 3-5 times per week and will be taught an exercise to improve transversus abdominis activation (bracing or abdominal following). The outcome measures will be fear avoidance and beliefs, pressure pain threshold, pain self-efficacy, catastrophizing, pain intensity, and treatment expectation. Outcome measures will be collected at one-week before intervention, immediately post-intervention, and four-weeks post-intervention.
CONCLUSION
The innovative approach of PNE oriented to fear beliefs proposed in this study could broaden the application strategies of this educational therapeutic modality. Impact. Contextualized PNE delivered by physical therapist could be essential to achieve a good cost-effectiveness ratio of this intervention to improve the clinical condition of people with CLBP.
Topics: Humans; Low Back Pain; Neurosciences; Patient Education as Topic; Chronic Pain; Male; Female; Adult; Catastrophization; Pain Measurement; Middle Aged; Treatment Outcome; Self Efficacy; Exercise Therapy
PubMed: 38832030
DOI: 10.7717/peerj.17507 -
Clinical, Cosmetic and Investigational... 2024This pilot study aims to explore how skin parameters and body composition impact the tolerance to EMS (Electrical Muscle Stimulation) stimuli in women, particularly...
PURPOSE
This pilot study aims to explore how skin parameters and body composition impact the tolerance to EMS (Electrical Muscle Stimulation) stimuli in women, particularly focusing on pain tolerance in response to varying intensities of EMS. This research seeks to understand what is essential for optimizing EMS applications.
PATIENTS AND METHODS
The study involved 16 females (age 35.9 ± 12.3). Body composition and anthropometric measurements were taken, including BMI (Body Mass Index), weight percentage, WHtR (Waist to Height Ratio), WHR (Waist-Hip Ratio), and Bioelectrical Impedance Analysis. High-frequency ultrasound scans were conducted to assess skin parameters. The EMS stimulation was performed using an Evolvex (InMode, Israel), with applicators placed around the abdomen and intensity adjusted according to patient tolerance, recorded at the pain threshold.
RESULTS
The maximum tolerated EMS stimulus varied from 12V to 55V, with a median of 33V. Body weight showed a strong positive correlation (R=0.76, p<0.001) and hip circumference (R=0.66, p<0.001) with EMS intensity. Body fat mass (R=0.61, p=0.012) and visceral fat area (R=0.55, p=0.029) were positively correlated with EMS intensity. However, no significant correlations were observed between EMS tolerance and muscle tissue parameters or total body water content. The study also found that skin structure parameters showed no significant impact on EMS tolerance.
CONCLUSION
The study reveals that women's tolerance to EMS stimuli is influenced by various factors. Anthropometric parameters like hip circumference, body weight, skinfold, and BMI are strongly correlated with EMS tolerance. Body composition factors, particularly adipose tissue characteristics such as body fat mass and percentage, also significantly impact EMS intensity requirements, with no notable correlation to muscle tissue or water content. However, variations in skin structure, including thickness and density, do not significantly affect EMS tolerance. These insights are crucial for tailoring personalized EMS therapy to enhance effectiveness and comfort in both aesthetic and rehabilitative applications.
PubMed: 38827630
DOI: 10.2147/CCID.S463676 -
PeerJ 2024Effective rehabilitation of upper limb musculoskeletal disorders requires multimodal assessment to guide clinicians' decision-making. Furthermore, a comprehensive...
BACKGROUND
Effective rehabilitation of upper limb musculoskeletal disorders requires multimodal assessment to guide clinicians' decision-making. Furthermore, a comprehensive assessment must include reliable tests. Nevertheless, the interrelationship among various upper limb tests remains unclear. This study aimed to evaluate the reliability of easily applicable upper extremity assessments, including absolute values and asymmetries of muscle mechanical properties, pressure pain threshold, active range of motion, maximal isometric strength, and manual dexterity. A secondary aim was to explore correlations between different assessment procedures to determine their interrelationship.
METHODS
Thirty healthy subjects participated in two experimental sessions with 1 week between sessions. Measurements involved using a digital myotonometer, algometer, inclinometer, dynamometer, and the Nine-Hole Peg test. Intraclass correlation coefficients, standard error of the mean, and minimum detectable change were calculated as reliability indicators. Pearson's correlation was used to assess the interrelationship between tests.
RESULTS
For the absolute values of the dominant and nondominant sides, reliability was 'good' to 'excellent' for muscle mechanical properties, pressure pain thresholds, active range of motion, maximal isometric strength, and manual dexterity. Similarly, the reliability for asymmetries ranged from 'moderate' to 'excellent' across the same parameters. Faster performance in the second session was consistently found for the Nine-Hole Peg test. No systematic inter-session errors were identified for the values of the asymmetries. No significant correlations were found between tests, indicating test independence.
CONCLUSION
These findings indicate that the sensorimotor battery of tests is reliable, while monitoring asymmetry changes may offer a more conservative approach to effectively tracking recovery of upper extremity injuries.
Topics: Humans; Male; Female; Reproducibility of Results; Adult; Range of Motion, Articular; Hand; Forearm; Young Adult; Healthy Volunteers; Muscle, Skeletal; Pain Threshold
PubMed: 38827299
DOI: 10.7717/peerj.17403 -
Cureus May 2024Mitochondrial dysfunction is associated with various diseases. Mitochondria plays a regulatory role during infection. The association between mitokines and subsequent...
Mitochondrial dysfunction is associated with various diseases. Mitochondria plays a regulatory role during infection. The association between mitokines and subsequent COVID progression has not been previously studied. The retrospective cohort study aimed to investigate the potential of serum mitokines as long COVID biomarkers in non-hospitalized patients. Patients with confirmed SARS-CoV-2 infection and blood test reports between January 2021 and April 2023 were included. Patients were categorized into two groups, the recovered and long COVID groups, based on fatigue, decline in focus, and pain. Serum levels of growth differentiation factor 15 (GDF-15) and fibroblast growth factor-21 (FGF-21), which are affected by mitochondrial function, along with inflammatory and vascular endothelium markers, were measured using enzyme-linked immunosorbent assays (ELISA). A receiver operating characteristic curve was used to screen the biomarkers. The threshold value of GDF-15 in the acute phase was 965 pg/mL (sensitivity: 71.4%, specificity: 83.3%), indicating that GDF-15 may be associated with the presence of symptoms three months post onset. No association with inflammatory markers and vascular structures was observed. Therefore, elevated GDF-15 levels in the acute phase may act as a predictive biomarker of long COVID.
PubMed: 38826986
DOI: 10.7759/cureus.59433 -
Environmental Health and Preventive... 2024Methylmercury (MeHg), the causative agent of Minamata disease, damages the cranial nervous system and causes specific sensory disturbances, especially hypoesthesia, in...
BACKGROUND
Methylmercury (MeHg), the causative agent of Minamata disease, damages the cranial nervous system and causes specific sensory disturbances, especially hypoesthesia, in the extremities. However, recent reports demonstrate that patients with chronic Minamata disease conversely develop neuropathic pain in the lower extremities. Studies on our established Minamata disease model rats showed that MeHg-mediated neurodegeneration might induce neuropathic pain by over time through inducing rewiring with neuronal activation in the somatosensory cortex via microglial activation in the spinal dorsal horn.
METHODS
In this study, the effects of gabapentin, a potentially effective treatment for neuropathic pain, was evaluated using this Minamata disease model rats. To further elucidate the mechanism of its medicinal effects, histochemical and biochemical analyses of the nervous system of Minamata disease model rats were conducted.
RESULTS
Gabapentin treatment restored the reduction in the pain threshold caused by MeHg exposure in rats. Histochemical and biochemical analyses revealed that gabapentin showed no effect on MeHg-induced neurodegeneration in entire nervous system and microglial activation in the spinal dorsal horn. However, it was shown that gabapentin may reduce excessive synaptogenesis through its antagonist action on the alpha2-delta-1 subunit of calcium channels in the somatosensory cortex.
CONCLUSIONS
These results indicate that gabapentin may alleviated neuropathic pain in MeHg poisoning, as typified by Minamata disease, by reversibly modulation synaptic rewiring in the somatosensory cortex.
Topics: Animals; Gabapentin; Neuralgia; Rats; Male; Disease Models, Animal; Methylmercury Compounds; Analgesics; Amines; Cyclohexanecarboxylic Acids; gamma-Aminobutyric Acid; Rats, Wistar
PubMed: 38825526
DOI: 10.1265/ehpm.24-00035 -
The Lancet. Rheumatology Jul 2024Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention... (Randomized Controlled Trial)
Randomized Controlled Trial
Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.
BACKGROUND
Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack).
METHODS
Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486.
FINDINGS
Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care.
INTERPRETATION
The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice.
FUNDING
National Institute for Health and Care Research Health Technology Assessment (16/111/78).
Topics: Humans; Low Back Pain; Cost-Benefit Analysis; Female; Male; Middle Aged; Primary Health Care; Self-Management; Telephone; Adult; Internet-Based Intervention; Treatment Outcome; United Kingdom; Disability Evaluation; Internet
PubMed: 38824934
DOI: 10.1016/S2665-9913(24)00086-9 -
Chiropractic & Manual Therapies May 2024Clinical practice guidelines recommend spinal manipulation for patients with low back pain. However, the effects of spinal manipulation have contradictory findings... (Randomized Controlled Trial)
Randomized Controlled Trial
One spinal manipulation session reduces local pain sensitivity but does not affect postural stability in individuals with chronic low back pain: a randomised, placebo-controlled trial.
BACKGROUND
Clinical practice guidelines recommend spinal manipulation for patients with low back pain. However, the effects of spinal manipulation have contradictory findings compared to placebo intervention. Therefore, this study investigated the immediate effects of lumbar spinal manipulation on pressure pain threshold (PPT) and postural stability in people with chronic low back pain (cLBP). Second, we investigated the immediate effect of lumbar spinal manipulation on pain intensity and the interference of the participant beliefs about which treatment was received in the PPT, postural stability, and pain intensity.
METHODS
A two-arm, randomised, placebo-controlled, double-blind trial was performed. Eighty participants with nonspecific cLPB and a minimum score of 3 on the Numeric Pain Rating Scale received one session of lumbar spinal manipulation (n = 40) or simulated lumbar spinal manipulation (n = 40). Primary outcomes were local and remote PPTs and postural stability. Secondary outcomes were pain intensity and participant's perceived treatment allocation. Between-group mean differences and their 95% confidence intervals (CIs) estimated the treatment effect. One-way analysis of covariance (ANCOVA) was performed to assess whether beliefs about which treatment was received influenced the outcomes.
RESULTS
Participants had a mean (SD) age of 34.9 (10.5) years, and 50 (62.5%) were women. Right L5 [between-group mean difference = 0.55 (95%CI 0.19 to 0.90)], left L5 [between-group mean difference = 0.45 (95%CI 0.13 to 0.76)], right L1 [between-group mean difference = 0.41 (95%CI 0.05 to 0.78)], left L1 [between-group mean difference = 0.57 (95%CI 0.15 to 0.99)], left DT [between-group mean difference = 0.35 (95%CI 0.04 to 0.65)], and right LE [between-group mean difference = 0.34 (95%CI 0.08 to 0.60)] showed superior treatment effect in the spinal manipulation group than sham. Neither intervention altered postural stability. Self-reported pain intensity showed clinically significant decreases in both groups after the intervention. A higher proportion of participants in the spinal manipulation group achieved more than two points of pain relief (spinal manipulation = 90%; sham = 60%). The participants' perceived treatment allocation did not affect the outcomes.
CONCLUSION
One spinal manipulation session reduces lumbar pain sensitivity but does not affect postural stability compared to a sham session in individuals with cLPB. Self-reported pain intensity lowered in both groups and a higher proportion of participants in the spinal manipulation group reached clinically significant pain relief. The participant's belief in receiving the manipulation did not appear to have influenced the outcomes since the adjusted model revealed similar findings.
Topics: Humans; Low Back Pain; Female; Manipulation, Spinal; Male; Adult; Double-Blind Method; Postural Balance; Pain Threshold; Middle Aged; Pain Measurement; Chronic Pain; Treatment Outcome
PubMed: 38822395
DOI: 10.1186/s12998-024-00541-4 -
International Journal of Pharmaceutics Jun 2024Neuropathic pain is chronic pain caused by a lesion or disease of the somatosensory nervous system. Neuropathic pain, with a high incidence and complex pathogenesis, is...
Neuropathic pain is chronic pain caused by a lesion or disease of the somatosensory nervous system. Neuropathic pain, with a high incidence and complex pathogenesis, is one of the most significant areas of clinical medicine and basic research. Currently, prescribed treatments are still unsatisfactory or have limited effectiveness. A medicinal preparation is required that relieves the neuropathic pain and prolongs action time, which has not yet been discovered. In this study, MIL-101 (Fe) was employed as a drug carrier to regulate the release of diclofenac sodium, thereby achieving the effect of analgesia and sustained release. The release curves demonstrated that diclofenac sodium could be continuously released from MIL-101 (Fe) for more than 48 h. There was no toxicity in vitro and in vivo, and the safety of MIL-101 (Fe) was confirmed by hematoxylin and eosin as well as ELISA tests in vivo. The results of behavioral testing, pharmacokinetics, and RNA sequencing analysis showed that MIL-101 (Fe) loaded with diclofenac sodium could enhance the mechanical withdrawal threshold and alleviate cold allodynia induced by Spared Nerve Injury, prolonging the work time by three days. The results indicated that MIL-101 (Fe) exhibited excellent biocompatibility, while the MIL-101 (Fe)-DS demonstrated analgesic and controlled-release properties. These findings provide a scientific foundation for the clinical management of neuropathic pain and the development of a novel formulation.
Topics: Animals; Diclofenac; Neuralgia; Male; Rats, Sprague-Dawley; Spinal Cord; Transcriptome; Nanomedicine; Rats; Drug Carriers; Anti-Inflammatory Agents, Non-Steroidal; Drug Liberation; Delayed-Action Preparations; Disease Models, Animal; Hyperalgesia
PubMed: 38821436
DOI: 10.1016/j.ijpharm.2024.124276 -
PloS One 2024People experiencing homelessness are more likely to experience poor health with physical functioning deficits and frailty commonly reported. It is not well known how... (Clinical Trial)
Clinical Trial
Outcomes of the LEAP feasibility trial-A low-threshold, exercise programme with protein supplementation to target frailty and poor physical functioning in people experiencing homelessness and addiction issues.
BACKGROUND
People experiencing homelessness are more likely to experience poor health with physical functioning deficits and frailty commonly reported. It is not well known how strategies to target physical functioning deficits and frailty work in practice in this group. The primary aim of this study was to explore the feasibility of an exercise intervention with protein supplementation to target physical functioning and frailty in people experiencing homelessness evaluated by recruitment and retention rates, adherence to the exercise sessions and protein supplement, adverse effects, programme feedback and characteristics of non-returners, sporadic and frequent attenders. The secondary aim was to evaluate changes in effectiveness outcomes of grip strength, muscle mass, lower extremity physical function, pain, frailty, and risk of malnutrition.
METHOD
This prospective single-arm study evaluated the feasibility of a 16-week rolling, low-threshold, 'drop-in' once weekly exercise programme with protein supplementation. The main recruitment site was a day-service centre for people who are homeless. Feasibility was assessed by the recruitment and retention rates, adherence to the exercise sessions and protein supplement as well as adverse effects, programme feedback and evaluation of characteristics of non-returners, sporadic (≤50% of available sessions) and frequent attenders (≥50% of available sessions). Effectiveness outcomes included pain (Visual Analogue Scale), physical functioning and performance (hand-grip dynamometry, limb circumference, the Short Physical Performance Battery), frailty (SHARE-FI and Clinical Frailty Scale) and nutritional status (Mini Nutritional Assessment).
RESULTS
Thirty-one participants were recruited mean (SD) age 45(16) years. There was a recruitment rate of a median (IQR) of 2(1-3) new participants per week. The retention rate was 45% (n = 14) to the main recruitment site. Adherence to the exercise sessions and nutritional intervention was 90% and 100% respectively. Three adverse events were recorded during 74 interventions over the 16-week programme. The acceptability of the programme was highlighted in participant feedback. Characteristics of frequent returners (≥50%) were older age, female, more stably housed and more stable in addiction. The programme did not induce any changes in effectiveness outcomes.
CONCLUSION
The feasibility of this programme was demonstrated. Overall, the programme was well received with higher retention rates in older participants, females, those more stably housed and those stable in addiction. A higher powered, more intense programme is needed to demonstrate programme effectiveness.
Topics: Humans; Male; Female; Middle Aged; Feasibility Studies; Exercise Therapy; Dietary Supplements; Frailty; Ill-Housed Persons; Adult; Prospective Studies; Dietary Proteins; Hand Strength; Aged; Exercise
PubMed: 38820432
DOI: 10.1371/journal.pone.0301926 -
Molecular Pain 2024This study investigated the ERK pathway of the peripheral nervous system and discovered a gender-specific pattern of ERK activation in the dorsal root ganglion of an...
This study investigated the ERK pathway of the peripheral nervous system and discovered a gender-specific pattern of ERK activation in the dorsal root ganglion of an acid-induced chronic widespread muscular pain model. We employed a twice acid-induced chronic musculoskeletal pain model in rats to evaluate mechanical pain behavior in both male and female groups. We further conducted protein analysis of dissected dorsal root ganglions from both genders. Both male and female rats exhibited a similar pain behavior trend, with females demonstrating a lower pain threshold. Protein analysis of the dorsal root ganglion (DRG) showed a significant increase in phosphorylated ERK after the second acid injection in all groups. However, phosphorylation of ERK was observed in the dorsal root ganglion, with higher levels in the male ipsilateral group compared to the female group. Moreover, there was a no difference between the left and right sides in males, whereas the significant difference was observed in females. In conclusions, the administration of acid injections induced painful behavior in rats, and concurrent with this, a significant upregulation of pERK was observed in the dorsal root ganglia, with a greater magnitude of increase in males than females, and in the contralateral side compared to the ipsilateral side. Our findings shed light on the peripheral mechanisms underlying chronic pain disorders and offer potential avenues for therapeutic intervention.
Topics: Animals; Male; Female; Fibromyalgia; Ganglia, Spinal; Rats, Sprague-Dawley; Extracellular Signal-Regulated MAP Kinases; Sex Characteristics; Phosphorylation; Rats; Pain Threshold; Disease Models, Animal; Pain
PubMed: 38818809
DOI: 10.1177/17448069241261940