Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409871
• Other study ID #: Adhesive shoulder capsulitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Universidad de Granada
• Contact: Rafael Guzmán García
• Phone: 0034 659740133
• Email: pnilasierra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• Physiotherapy treatment.
-Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy.
• Physiotherapy 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.

Locations

Country	Name	City	State
Spain	Hospital Reina Sofía de Córdoba	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal glucose	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be basal glucose.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Insulin HOMA index	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be insulin HOMA index.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Leptin	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be leptin.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Triglycerides	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be triglycerides.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Total cholesterol	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be total cholesterol.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	HDL cholesterol	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be HDL cholesterol.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Uric acid	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be uric acid.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	C-reactive protein	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be C-reactive protein.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Primary	Inflammatory cytokines	Whole blood collected by venipuncture will be used as the starting point. The Code of Good Practice elaborated by the Working Group of Hematological Derivates will be followed at all times. The variable to be evaluated will be inflammatory cytokines.	It was measured before starting treatment and at the end of treatment, an average of 6 months.
Secondary	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.
Secondary	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.
Secondary	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.	It was measured before starting treatment and at the end of the treatment, an average of 6 months.
Secondary	Food Frequency Questionnaire (FFQ)	It is a questionnaire that is designed to evaluate the frequency with which food is consumed, during a specific time. Generally a list of foods is provided including categories to check off, indicating how often they are consumed on a monthly, weekly or daily basis.	It was measured before starting treatment and at the end of the treatment, an average of 6 months.
Secondary	Mediterranean diet adherence questionnaire	This test has 16 questions that must be answered affirmatively/negatively (yes/no). Answers representing a positive aspect add 1 point, and answers representing a negative connotation subtract 1 point. The total score obtained gives rise to the KIDMED index: optimal Mediterranean diet (8 to 12 points), need to improve the dietary pattern (4 to 7 points) and very poor quality diet (0 to 3 points).	It was measured before starting treatment and at the end of the treatment, an average of 6 months.
Secondary	American Shoulder and Elbow Surgeons (ASES) Questionnaire	It is one of the most widely used tools to evaluate shoulder function. It contains 11 items that are divided into: a function dimension and a pain dimension, assigning between 0 and 50 points each. The sum is the total score of the scale, and higher values indicate a better state of health.	It was measured before starting treatment and at the end of the treatment, an average of 6 months.