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

U

University of Granada (UGR)

Status

Completed

Conditions

Adhesive Capsulitis of Shoulder

Treatments

Other: Physiotherapy treatment and modification of the biorhythm.
Other: Physiotherapy treatment.

Study type

Interventional

Funder types

Other

Identifiers

NCT06409871
Adhesive shoulder capsulitis

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups, including a placebo group

Physiotherapy treatment
Placebo Comparator group
Description:
Conventional physiotherapy treatment will be applied. The duration will be two weekly sessions of about 50 minutes, for 6 weeks.
Treatment:
Other: Physiotherapy treatment.
Physiotherapy treatment and modification of the biorhythm
Experimental group
Description:
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.
Treatment:
Other: Physiotherapy treatment and modification of the biorhythm.

Trial contacts and locations

1

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Central trial contact

Rafael Guzmán García

Data sourced from clinicaltrials.gov

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