UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052994 |
|---|---|
| Receipt number | R000060460 |
| Scientific Title | Effect of home-based telemedicine with wearable devices in patients with chronic musculoskeletal pain |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2023/12/04 16:21:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of home-based telemedicine with wearable devices in patients with chronic musculoskeletal pain
Acronym
Effect of home-based telemedicine with wearable devices
Scientific Title
Effect of home-based telemedicine with wearable devices in patients with chronic musculoskeletal pain
Scientific Title:Acronym
Effect of home-based telemedicine with wearable devices
Region
| Japan |
Condition
Condition
Chronic musculoskeletal pain
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of home-based telemedicine with wearable devices and usual care, compared with usual care, in patients with chronic musculoskeletal pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain-Numeric Rating Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Telemedicine with wearable devices and usual care
Interventions/Control_2
Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) were older than 20 years of age, (2) had persistent primary musculoskeletal pain of a minimum duration of 6 months before entry into the study, and (3) and at least 3 out of a 10-point pain-Numeric Rating Scale for subjective pain intensity
Key exclusion criteria
(1) were no wish to participation, (2) had tumor related pain or presence of neurological symptoms, (3) were within 3 months after surgeries, and (4) were taking medication associated with dementia.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
5430027
Address
2-75 Fudegasaki Tennoji, Osaka
TEL
06-6771-1227
hisyohayaishi@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
5430027
Address
2-75 Fudegasaki Tennoji, Osaka
TEL
06-6771-1227
Homepage URL
hisyohayaishi@gmail.com
Sponsor or person
Institute
Hayaishi Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Pain Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hayaishi Hospital
Address
2-75 Fudegasaki Tennoji, Osaka
Tel
06-6771-1227
info@hayaishi.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060460
