Clinical trial NCT06409871: Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.
Official title: Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: Adhesive Shoulder Capsulitis
Metabolic Profile
Inflammation Mediators
Insomnia Disorders
Biological Rhythms
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain and Disability Questionnaire (SPADI)
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Fasting glucose Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Insulin Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: HOMA Index Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Leptin Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Triglycerides Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Total Colesterol Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: HDL Colesterol Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: Uric Acid Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: High-sensitivity C-reactive Protein Metabolic Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: IL-1 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: IL-6 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: IL-17 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: IL-10 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: IL-33 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: HMGB1 Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: CRP Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
measure: TNF Inflammatory Profile
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Secondary outcomes:
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: It was measured before starting treatment and at the end of the treatment, an average of 6 months.
measure: Shoulder mobility
timeFrame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Reina Sofía de Córdoba
Study officials:
References: