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The efficacy of brace for night pain of shoulder

The efficacy of shoulder brace for the night pain induced by shoulder disorders: Open-label parallel group comparative study - The efficacy of brace for night pain of shoulder

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032200123
Enrollment
20
Registered
2020-09-17
Start date
2020-11-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

shoulder disorders Frozen shoulder

Interventions

Sponsors

Kenmoku Tomonori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Sleep time

Secondary

MeasureTime frame
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)

Contacts

Public ContactTomonori Kenmoku

Kitasato University School of Medicine

kenmoku@med.kitasato-u.ac.jp+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026