UMIN-CTR Clinical Trial

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
Email	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
Email	kataoka-hide@kii.bbiq.jp

Sponsor
Institute	Department of Physical Therapy Sciences, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040358