Adhesive Capsulitis of ShoulderNCT06409871
Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.
A study testing Physiotherapy treatment. and Physiotherapy treatment and modification of the biorhythm. in people with Adhesive Capsulitis of Shoulder, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Physiotherapy treatment. and Physiotherapy treatment and modification of the biorhythm.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2024to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects diagnosed with adhesive shoulder capsulitis aged between 18 and 60 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Physiotherapy treatment., Physiotherapy treatment and modification of the biorhythm.
- Keywords
- Adhesive Shoulder Capsulitis, Metabolic Profile, Inflammation Mediators, Insomnia Disorders, Biological Rhythms
- Medical subject headings
- Bursitis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy treatment | Placebo comparator | Conventional physiotherapy treatment will be applied. The duration will be two weekly sessions of about 50 minutes, for 6 weeks. Receives: 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. Receives: Other: Physiotherapy treatment and modification of the biorhythm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: It was measured before starting treatment and at the end of the treatment, an average of 6 months.
Shoulder mobility
Participants' shoulder range of motion will be assessed using an inclinometer. Flexion-extension, abduction-adduction and rotations will be measured.
Measured: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 May 2024
- Primary completion30 Nov 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAFAEL GUZMAN GARCIA, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409871
- Sponsor's protocol ID
- Adhesive shoulder capsulitis
- Status last verified
- Mar 2025
- First submitted
- 2 May 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis.
- ClinicalTrials.gov ID
- NCT06409871
- Acronym / sponsor ID
- Adhesive shoulder capsulitis
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- Adhesive Shoulder Capsulitis, Metabolic Profile, Inflammation Mediators, Insomnia Disorders, Biological Rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy treatment | Placebo comparator | Other: Physiotherapy treatment.Conventional physiotherapy treatment will be applied. The duration will be two weekly sessions of about 50 minutes, for 6 weeks. |
| Physiotherapy treatment and modification of the biorhythm | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with adhesive shoulder capsulitis aged between 18 and 60 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy treatment.-Physiotherapy treatment will consist of joint mobilisation, proprioceptive neuromuscular facilitation and manual therapy. | Other | Physiotherapy treatment |
| 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. | Other | Physiotherapy treatment and modification of the biorhythm |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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.
Shoulder mobility
Time frame: It was measured before starting treatment and at the end of treatment, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy treatment. and Physiotherapy treatment and modification of the biorhythm. in people with Adhesive Capsulitis of Shoulder, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Disability Questionnaire (SPADI) (time frame: It was measured before starting treatment and at the end of treatment, an average of 6 months.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.