Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain and Disability Questionnaire (SPADI)
研究概览
简要总结
Adhesive shoulder capsulitis is a condition characterised by stiffness or lack of mobility of the shoulder. This results in a negative impact on quality of life and increased health care costs. Inflammation is a key factor in the pathogenesis of these patients. In addition, poor sleep quality and/or sleep deprivation can increase the production of pro-inflammatory cytokines, which contributes to the development of chronic inflammatory and metabolic diseases.
The most important function of sleep is recovery. Good sleep promotes healing, aids in the recovery of the immune, neurological, musculoskeletal systems and is necessary for pain sufferers to improve. The quantity and quality of sleep has an impact on the subject's inflammatory and metabolic markers.
In relation to the quantity and quality of sleep, it has been shown that foods and/or beverages rich in methylxanthine such as coffee, tea and chocolate can alter these parameters. As is the case with exposure to blue light emitted by electronic devices. The population are faced with deep-rooted habits in their daily lives that do not help to control pain in these patients.
HYPOTHESIS:
Due to the above, the following hypothesis is established:
Lack of consumption of food or beverages rich in methylxanthine and limiting the use of mobile devices two hours before going to sleep favours recovery from adhesive shoulder capsulitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with adhesive shoulder capsulitis aged between 18 and 60 years.
排除标准
- •Locked shoulder dislocations, shoulder arthritis, shoulder fractures, avascular necrosis, previous surgery in the hypochondrium region within the last year, having a medical or skin condition that prevents them from receiving tactile stimuli in the shoulder area, presence of a neurological or motor disorder, having diagnosed psychopathology, visual impairment, or subjects with other diseases that may affect sleep quality or inflammatory parameters.
结局指标
主要结局
Pain and Disability Questionnaire (SPADI)
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
It is a quality of life questionnaire developed to assess pain and disability associated with shoulder dysfunction. The SPADI is a 13-item shoulder function index of responders' ability to perform basic activities of daily living. Each item is scored using a numerical rating scale ranging from zero (no pain/no difficulty) to ten (worst pain imaginable/so difficult that help was required). SPADI provides a pain scale (five items; scale score range from zero to 50 points, expressed as a percentage) and a disability scale (eight items; scale score range from zero to 80 points, expressed as a percentage). The scores of the two scales are averaged to obtain a total Spanish version of the SPADI score (zero to 100 points). A higher score indicates greater pain-related disability.
Fasting glucose Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Fasting glucose (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
Insulin Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Insuline (mU/L) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
HOMA Index Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
HOMA index was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
Leptin Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Leptin (ng/ml) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
Triglycerides Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Triglycerides (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
Total Colesterol Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Total colesterol (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
HDL Colesterol Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
HDL colesterol (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
Uric Acid Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Uric acid (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
High-sensitivity C-reactive Protein Metabolic Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
High-sensitivity C-reactive Protein (mg/L) was measured. Blood sample was obtained following the guidelines of the National Biobank Network.
IL-1 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
IL-1 (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
IL-6 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
IL-6 (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
IL-17 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
IL-17 (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
IL-10 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
IL-10 (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
IL-33 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
IL-33 (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
HMGB1 Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
HMGB1 (ug/L) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
CRP Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
CRP (mg/L) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
TNF Inflammatory Profile
时间窗: It was measured before starting treatment and at the end of treatment, an average of 6 months.
TNF (pg/ml) was measured. The analysis of this inflammatory cytokines was conducted using ELISA (Enzyme-Linked Immunosorbent Assay), with a blood sample obtained according to the guidelines of the National Biobank Network.
次要结局
- Pittsburg Sleep Quality Index (PSQI)(It was measured before starting treatment and at the end of the treatment, an average of 6 months.)
- Shoulder mobility(It was measured before starting treatment and at the end of treatment, an average of 6 months.)
研究者
RAFAEL GUZMAN GARCIA
Principal Investigator
Universidad de Granada