The efficacy of brace for night pain of shoulder

JRCT ID: jRCTs032200123

Registered date:17/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: shoulder disorders
• Date of first enrollment: 17/09/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Brace

Outcome(s)

• Primary Outcome: Sleep time

Secondary Outcome

1.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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1)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

• Primary Sponsor: Kenmoku Tomonori
• Source(s) of Monetary Support: Alcare Co., Ltd.