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

NCT06409871 | Completed

• 1 other identifier: Adhesive shoulder capsulitis
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

Adhesive Shoulder Capsulitis; Metabolic Profile; Inflammation Mediators; Insomnia Disorders; Biological Rhythms

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (2)

• Pittsburg Sleep Quality Index (PSQI)

  It was measured before starting treatment and at the end of the treatment, an average of 6 months.

• Shoulder mobility

  It was measured before starting treatment and at the end of treatment, an average of 6 months.

Study Arms (2)

Physiotherapy treatment

PLACEBO COMPARATOR

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 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.

Other: Physiotherapy treatment and modification of the biorhythm.

Interventions

Physiotherapy treatment. OTHER

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

Physiotherapy treatment

Physiotherapy treatment and modification of the biorhythm. OTHER

* 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.

Physiotherapy treatment and modification of the biorhythm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects diagnosed with adhesive shoulder capsulitis aged between 18 and 60 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Hospital Reina Sofía de Córdoba

Córdoba, Spain

Location

MeSH Terms

Conditions

Bursitis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 10, 2024
• Study Start: May 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 16, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

ES (1)