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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037114
Receipt No. R000042287
Scientific Title Effects of pain neuroscience education in hospitalized patients with pain catastrophizing undergoing high tibial osteotomy: a pseudo-cluster randomized trial
Date of disclosure of the study information 2019/06/19
Last modified on 2019/06/19

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Basic information
Public title Effects of pain neuroscience education in hospitalized patients with pain catastrophizing undergoing high tibial osteotomy: a pseudo-cluster randomized trial
Acronym Effects of patient education in postoperative knee osteoarthritis
Scientific Title Effects of pain neuroscience education in hospitalized patients with pain catastrophizing undergoing high tibial osteotomy: a pseudo-cluster randomized trial
Scientific Title:Acronym Effects of patient education in postoperative knee osteoarthritis
Region
Japan

Condition
Condition high tibial osteotomy patient
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of a hospital-time Pain neuroscience education(PNE)intervention combined with physical therapist-prescribed rehabilitation in patients undergoing high tibial osteotomy patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes baseline (before surgery) and before discharge from the hospital (5 weeks postoperatively)
pain at rest and while walking as measured with an Numerical Rating Scale(NRS)
Key secondary outcomes Pain Catastrophizing Scale(PCS),Pain Self-Efficacy Questionnaire(PSEQ),Knee extension strength,10m walking test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group:PNE
The PNE was based on a psychosocial model and began 1 week postoperatively in a group setting(five 1-hour weekly sessions were conducted)
Interventions/Control_2 Intervention group and control group: Hospitalization Rehabilitation

This was started the day after surgery and was performed six times a week
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) read and speak Japanese and provided informed consent
(2) had a diagnosis of osteoarthritis as determined by their orthopedic surgeons, and(3) were scheduled for primary (not revision) unilateral open-wedge HTO
Key exclusion criteria (1) scheduled for revision arthroplasty surgery
(2) unable to or declined to provide consent for study participation
(3) had a self-reported diagnosis of inflammatory arthritis (i.e., rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis)
(4) had neurological or psychological disease
(5) scheduled to undergo HTO because of a fracture, malignancy, or infection
(6) scheduled for bilateral HTO
(7) scheduled for unilateral arthroplasty
(8) reported plans to undergo hip or knee arthroplasty within 6 months after the current HTO
(9) had a Pain Catastrophizing Scale (PCS) score of <21
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Deguchi
Organization Fukuoka Reha Orthopedics Clinic
Division name Department of Rehabilitation
Zip code 8198551
Address 7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka
TEL 092-812-1555
Email degunao722@yahoo.co.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Deguchi
Organization Fukuoka Reha Orthopedics Clinic
Division name Department of Rehabilitation
Zip code 8198551
Address 7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka
TEL 0928121555
Homepage URL
Email degunao722@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation, Fukuoka Rehabilitation Hospital
Institute
Department

Funding Source
Organization Fukuoka Rehabilitation Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka Rehabilitation Hospital
Address 7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka
Tel 092-812-1555
Email degunao722@yahoo.co.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 06 Month 19 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 96
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
2014 Year 04 Month 01 Day
Date of IRB
2014 Year 03 Month 12 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 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 06 Month 19 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042287

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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