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Completed

NCT Number: NCT06409871

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.

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Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Dyssomnias Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Reina Sofía de Córdoba

Córdoba, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy treatment.

Other

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

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.

Primary outcomes

  1. Pain and Disability Questionnaire (SPADI)

    Time frame: 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.

  2. Fasting glucose Metabolic Profile

    Time frame: 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.

  3. Insulin Metabolic Profile

    Time frame: 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.

  4. HOMA Index Metabolic Profile

    Time frame: 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.

  5. Leptin Metabolic Profile

    Time frame: 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.

  6. Triglycerides Metabolic Profile

    Time frame: 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.

  7. Total Colesterol Metabolic Profile

    Time frame: 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.

  8. HDL Colesterol Metabolic Profile

    Time frame: 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.

  9. Uric Acid Metabolic Profile

    Time frame: 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.

  10. High-sensitivity C-reactive Protein Metabolic Profile

    Time frame: 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.

  11. IL-1 Inflammatory Profile

    Time frame: 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.

  12. IL-6 Inflammatory Profile

    Time frame: 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.

  13. IL-17 Inflammatory Profile

    Time frame: 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.

  14. IL-10 Inflammatory Profile

    Time frame: 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.

  15. IL-33 Inflammatory Profile

    Time frame: 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.

  16. HMGB1 Inflammatory Profile

    Time frame: 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.

  17. CRP Inflammatory Profile

    Time frame: 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.

  18. TNF Inflammatory Profile

    Time frame: 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.

Secondary outcomes

  1. Pittsburg Sleep Quality Index (PSQI)

    Time frame: 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.

  2. Shoulder mobility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 10, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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