UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035426 |
|---|---|
| Receipt number | R000040358 |
| Scientific Title | Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2022/06/05 20:07:28 |
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Basic information
Public title
Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients
Acronym
Effects of CBT on vertebral compression fractures patients
Scientific Title
Effect verification of rehabilitation combined with cognitive behavioral therapy on vertebral compression fractures patients
Scientific Title:Acronym
Effects of CBT on vertebral compression fractures patients
Region
| Japan |
Condition
Condition
Vertebral compression fractures
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial examined whether standard rehabilitation (SR) combined with cognitive-behavioral therapy (CBT) more effectively improve low back pain (LBP), fear-avoidance beliefs, physical performance, physical activity, activities of daily living, and quality of life than SR alone in patients with vertebral compression fracture (VCF).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity (baseline, 2weeks, discharge)
Key secondary outcomes
Physical activity
pain catastrophizing scale (PCS)
geriatric depression scale (GDS)-15
fall efficacy scale (FES)
Isometric knee extension force
vertebral body collapse
physical performance (TUGT, 6MWD, 5SST)
functional independence measure
EuroQol 5 Dimension (EQ5-D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Participants in the intervention group are given pedometers, which they wear at all times when awake, and daily diaries, and asked to record their daily pain intensity, behaviour and step counts adding standard rehabilitation. Furthermore they undergo goal-setting intervention. Intervention period is from two to four weeks.
Interventions/Control_2
Control group: The contents of the standard rehabilitation are specific to each patient; for example, the rehabilitation included a muscle-strengthening exercise, balance training, activities of daily living (ADL) training, and instrumental ADL training.
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of the present study included acute VCF patients, those who can walk independently, those who can understand Japanese, those who agreed to the participation of the study.
Key exclusion criteria
The exclusion criteria are fractures occured by high-energy traumas, patients who have severe cognitive dysfunction, and those have complications inhibiting rehabilitation (i.e. haemodynamically unstable, severe infection, and repeated vertebral fractures during hospital stay).
Target sample size
70
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 Sciences
Zip code
8528034
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
0958711515
kataoka-hide@kii.bbiq.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki Memorial Hospital
Division name
Department of Rehabilitation
Zip code
851-0301
Address
Hukahori 1-11-54, Nagasaki, Japan
TEL
0958711515
Homepage URL
kataoka-hide@kii.bbiq.jp
Sponsor or person
Institute
Department of Physical Therapy Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Nagasaki University Graduate chool of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
Sakamoto 1-7-1, Nagasaki, 852-8520, Japan
Tel
095-819-7198
yoshi-t@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
| 2019 | Year | 01 | Month | 07 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2022 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040358
