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

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Other: Physiotherapy treatment.; Other: Physiotherapy treatment and modification of the biorhythm.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain
    • Hospital Reina Sofia de Cordoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Physiotherapy treatment; Conventional physiotherapy treatment will be applied. The duration will be two weekly sessions of about 50 minutes, for 6 weeks.	Other: Physiotherapy treatment.; -Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy.
Experimental: Physiotherapy treatment and modification of the biorhythm; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation Mediators; Metabolic Profile; Adhesive Shoulder Capsulitis; Insomnia Disorders; Biological Rhythms
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: Adhesive shoulder capsulitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No