RESUMEN
Background: : Pharmacopuncture therapy and acupotomy are commonly used in combination for Conventional Korean Medicine Treatments (CKMT) for the treatment of patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of LSS. Methods: : This study is designed as a pragmatic, assessor-blinded, randomized controlled trial with two parallel arms in a 1:1 ratio. A total of 104 participants diagnosed with LSS will be randomly assigned to an experimental group (pharmacopuncture therapy and acupotomy in addition to CKMT) or a control group (only CKMT). Patients in both groups will receive treatment two times weekly for 6 weeks. The primary outcome will be the mean change on the 100-mm visual analog scale (VAS) from the baseline to the end of the treatment (week 6). The secondary outcomes will include the mean change in the 100-mm VAS from baseline to week 10 and week 14, respectively. Proportion of patients who achieve the clinically important difference, Zurich Claudication Questionnaire, Roland-Morris disability questionnaire, self-reported maxium walking distance, EuroQol 5-dimension 5-level, and Patients' Global Impression of Change will also be assessed. Adverse events will be assessed at each visit. The outcomes will be measured for a total of 14 weeks, including a treatment period of 6 weeks and follow-up of 4, 8 weeks. Discussion: : The results of this trial will confirm the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of patients with LSS.
Asunto(s)
Terapia por Acupuntura , Acupuntura , Estenosis Espinal , Humanos , Terapia por Acupuntura/métodos , Vértebras Lumbares , Ensayos Clínicos Controlados Aleatorios como Asunto , Estenosis Espinal/terapia , Estenosis Espinal/etiología , Resultado del Tratamiento , Ensayos Clínicos Pragmáticos como AsuntoRESUMEN
BACKGROUND: Chronic low back pain (CLBP) is a common condition that affects millions of people worldwide. Moving cupping has gained popularity as a complementary therapy for managing CLBP owing to its noninvasive and cost-effective nature. However, the lack of objective measures to assess its therapeutic effect has been a considerable challenge in evaluating the effectiveness of moving cupping for CLBP management. METHODS: We developed a randomized controlled trial (RCT) protocol for evaluating the effectiveness of a noninvasive treatment using moving cupping by assessing muscle relaxation with shear wave elastography (SWE). It involves the recruitment of 68 patients with CLBP and randomly assigns them to either the treatment or control group. The treatment group will receive moving cupping therapy for 2 weeks, while the control group will receive placebo treatment. It will utilize SWE to evaluate muscle relaxation at baseline, after 2 weeks of treatment, and 1 week after the end of treatment. Subjective reports of pain intensity and quality of life are also recorded at each time point. DISCUSSION: The protocol developed here utilizes SWE to objectively measure muscle stiffness, and coupled with moving cupping therapy, may be effective in conveying relative comparisons before and after treatment. Moving cupping therapy is expected to promote muscle relaxation and pain relief in patients with CLBP. This study has the potential to contribute to the development of objective measures for evaluating the therapeutic effects of traditional therapies and to provide valuable insight into their efficacy.
Asunto(s)
Dolor Crónico , Diagnóstico por Imagen de Elasticidad , Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/diagnóstico por imagen , Dolor de la Región Lumbar/terapia , Dolor Crónico/diagnóstico por imagen , Dolor Crónico/terapia , Dimensión del Dolor/métodos , Manejo del Dolor , Resultado del TratamientoRESUMEN
Although the prevalence of insomnia and the association of insomnia with menopause have been well reported, not much work has been conducted in population-based research on insomnia and menopause in Korea. The purpose of the present report was to determine overall and different prevalence of insomnia by menopausal status, and the relationship between insomnia and menopause in a population-based sample of middle-aged Korean women. A total of 96.1% of 2497 randomly selected middle-aged Korean women participated. Insomnia was defined as occurring three times a week or more in the previous month. Subjects were categorized into three groups: premenopause, perimenopause, and postmenopause. The overall prevalence of insomnia in middle-aged Korean women was 14.3%. The most common symptom of insomnia was difficulty maintaining sleep (9.7%), followed by difficulty initiating sleep (7.9%), and early morning awakening (7.5%). Multiple logistic regression analysis revealed that menopause was independently associated with insomnia after adjusting for confounding factors such as age, income, and depression. Perimenopause was significantly associated with a dramatic increase in the risk of insomnia, but there was no significant association for postmenopause. The major finding is that insomnia is significantly associated with the menopausal transition. The prevalence of insomnia increases significantly by the transition from premenopause to perimenopause, but not to postmenopause. A further prospective study is needed to investigate the influence of menopause on insomnia.