UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047295 |
|---|---|
| Receipt number | R000053938 |
| Scientific Title | Verification of the effectiveness of telerehabilitation in preventing the occurrence of chronic pain caused by vertebral compression fractures - A Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/03/30 01:41:12 |
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Basic information
Public title
Effects of telerehabilitation on the prevention of chronic pain after vertebral compression fracture
Acronym
Effects of telerehabilitation for chronic pain after spinal compression fracture
Scientific Title
Verification of the effectiveness of telerehabilitation in preventing the occurrence of chronic pain caused by vertebral compression fractures - A Randomized Controlled Trial
Scientific Title:Acronym
Verification of the effectiveness of telerehabilitation for chronic pain after vertebral compression fracture
Region
| Japan |
Condition
Condition
Vertebral compression fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of an intervention to prevent the development of chronic pain after vertebral compression fracture by continuing an inpatient activity promotion program with telerehabilitation after discharge from the hospital in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of low back pain at discharge and 3 months post-discharge
Key secondary outcomes
pain catastrophizing scale -6
geriatric depression scale -5
Tampa Scale for kinesiophobia
pain self-efficacy questionnaire -2
chair stand test
timed up and go test
6 minutes Walking distance
Physical activity (accelerometer)
JOA Back Pain Evaluation Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Telerehabilitation group: After hospitalization due to fresh retebral compression fracture, patients will be rehabilitated with a physical activity program combined with usual exercise therapy and ADL practice. The physical activity program consists of goal-setting and achievement interviews, self-monitoring of pain and steps, and adjustment of steps. Specifically, patients were given a goal checklist and an activity diary, and asked to write down their goals, daily pain, number of steps taken, and comments. At the same time, based on the contents of the activity diary, feedback focusing on adaptive behavior was provided to make the participants aware that they can act even if they suffer from pain. After discharge from the hospital, telerehabilitation using a tablet will be provided once a week for 30 minutes for 12 weeks. During the telerehabilitation, patients are asked to continue the physical activity program and voluntary exercise that they will be doing during their hospitalization, and therapists provide guidance regarding the number of steps, exercise content, and daily life as appropriate.
Interventions/Control_2
Control group: During hospitalization, patients receive the same rehabilitation as in the telerehabilitation group. After discharge from the hospital, the therapist interviews the patients by telephone once a week about patients' physical condition only.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Injured with fresh vertebral compression fracture, age 50 years or older, independent in indoor walking, able to understand Japanese, able to operate the tablet and phone used in this study.
Key exclusion criteria
Those with visual impairment, those who cannot use tablets or telephone calls due to hearing impairment, those with dementia or related symptoms, and those with severe circulatory or respiratory diseases.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki Japan
TEL
0958197198
kataoka-hide@kii.bbiq.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki Japan
TEL
0958197967
Homepage URL
kataoka-hide@kii.bbiq.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
1-12-4 Sakamoto Nagasaki Japan
Tel
095-819-7198
miyaji195@nagasaki-u.ac.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-21K11169/
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053938
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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