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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy treatment | Placebo Comparator | Conventional physiotherapy treatment will be applied. The duration will be two weekly sessions of about 50 minutes, for 6 weeks. |
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| Physiotherapy treatment and modification of the biorhythm | Experimental | The same physiotherapy treatment will be applied together with the modification of their biorhythm. This will be recorded in a diary for 6 weeks, in which the time of going to bed and waking up will be recorded, together with the observation of the change in biorhythm. This group will also be provided with a second informed consent form including a data collection commitment document. The duration will be two weekly sessions of about 50 minutes, for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy treatment. | Other | -Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain and Disability Questionnaire (SPADI) | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Fasting glucose Metabolic Profile | Fasting glucose (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Insulin Metabolic Profile | Insuline (mU/L) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| HOMA Index Metabolic Profile | HOMA index was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Leptin Metabolic Profile | Leptin (ng/ml) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburg Sleep Quality Index (PSQI) | It is a questionnaire that assess sleep quality and sleep disturbances. It consists of 19 questions that address a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of sleep-related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The component scores are summed to give an overall PSQI score between 0 and 21. A higher scores indicates worse sleep quality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina SofÃa de Córdoba | Córdoba | Spain |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| Physiotherapy treatment and modification of the biorhythm. | Other |
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| It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Triglycerides Metabolic Profile | Triglycerides (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Total Colesterol Metabolic Profile | Total colesterol (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| HDL Colesterol Metabolic Profile | HDL colesterol (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| Uric Acid Metabolic Profile | Uric acid (mg/dl) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| High-sensitivity C-reactive Protein Metabolic Profile | High-sensitivity C-reactive Protein (mg/L) was measured. Blood sample was obtained following the guidelines of the National Biobank Network. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| IL-1 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| IL-6 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| IL-17 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| IL-10 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| IL-33 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| HMGB1 Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| CRP Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| TNF Inflammatory Profile | 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. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| It was measured before starting treatment and at the end of the treatment, an average of 6 months. |
| Shoulder mobility | Participants' shoulder range of motion will be assessed using an inclinometer. Flexion-extension, abduction-adduction and rotations will be measured. | It was measured before starting treatment and at the end of treatment, an average of 6 months. |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |