Adhesive Capsulitis of Shoulder
Conditions
Keywords
Adhesive Shoulder Capsulitis, Metabolic Profile, Inflammation Mediators, Insomnia Disorders, Biological Rhythms
Brief summary
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.
Interventions
OTHERPhysiotherapy treatment.
-Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy.
OTHERPhysiotherapy treatment and modification of the biorhythm.
* Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy. * Modification of the biorhythm will consist of eliminating methylxanthine-rich foods and/or beverages from their diet, as well as no exposure to electronic devices two hours before bedtime.
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with adhesive shoulder capsulitis aged between 18 and 60 years.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TNF Inflammatory Profile | 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. |
| HMGB1 Inflammatory Profile | 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 | 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. |
| Pain and Disability Questionnaire (SPADI) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder mobility | It was measured before starting treatment and at the end of treatment, an average of 6 months. | Participants' shoulder range of motion will be assessed using an inclinometer. Flexion-extension, abduction-adduction and rotations will be measured. |
| Pittsburg Sleep Quality Index (PSQI) | It was measured before starting treatment and at the end of the treatment, an average of 6 months. | 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. |
Countries
Spain
Outcome results
None listed