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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200123

Registered date:17/09/2020

The efficacy of brace for night pain of shoulder

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedshoulder disorders
Date of first enrollment13/11/2020
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Brace

Outcome(s)

Primary OutcomeSleep time
Secondary Outcome1.Incidence of adverse events 2.Sleep activity evaluation: halfway awakening time (min), sleep latency (min), sleep efficiency 3.Sleep activity evaluation: Total sleep time (minutes) in the last week of the treatment period 4.NRS for pain (night pain, movement pain, resting pain)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) Patients with nocturnal pain more than 1 week and patients without complete rotator cuff tears that determined by MRI. Definition of night pain: Pain that causes awakening during sleep due to lying down and lying on the side and makes it impossible to continue sleep. 2) Patients aged 20 years or older at the time of obtaining consent. 3) Patients who, after receiving a sufficient explanation before participating in this study, obtained their informed consent by themselves. 4) Patients who undergo outpatient treatment in an outpatient setting.
Exclude criteria1)Patients with any other inflammatory disease which can induce shoulder pain. 2)Patients with both shoulder pain 3)Patients with a history of allergy to the material of the device under test 4)Patients who may not be able to wear the device under test due to dementia or cerebral infarction 5)Patients with cervical spondylosis, cerebral infarction, and other causes of pain other than those in the shoulder joint 6)Patients who cannot discontinue use of anti-inflammatory analgesics (excluding transdermal topical agents), steroids, and neuropathic pain remedies that are concomitant use drugs such as rheumatoid arthritis and post-herpetic pain. 7)Patients who have obvious deformities in the shoulder joint due to shoulder disease or trauma 8)Patients suspected of peripheral nerve fragility that may cause transient paresis with the wearing of the device under test. 9)Patients who cannot stop sleep inducers 10)Patients whose lifestyle patterns are not constant, such as shift work (night shift, shift duty) 11)Other patients who the investigator determined to be inappropriate as patients

Related Information

Contact

Public contact
Name Tomonori Kenmoku
Address Kitazato 1-15-1 Minami-ku Sagamihara city Kanagawa Kanagawa Japan 252-0374
Telephone +81-42-778-8111
E-mail kenmoku@med.kitasato-u.ac.jp
Affiliation Kitasato University School of Medicine
Scientific contact
Name Tomonori Kenmoku
Address Kitazato 1-15-1 Minami-ku Sagamihara city Kanagawa Kanagawa Japan 252-0374
Telephone +81-42-778-8111
E-mail kenmoku@med.kitasato-u.ac.jp
Affiliation Kitasato University School of Medicine