UMIN-CTR Clinical Trial

Basic information
Public title	Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial
Acronym	Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial
Scientific Title	Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial
Scientific Title:Acronym	Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the effectiveness of postoperative pain management education by physical therapists in high tibial osteotomy patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain of rest and walking using the numerical rating scale at pre-operation and post-operation 5weeks
Key secondary outcomes	Pain catastrophizing using the pain catastrophizing scale, pain self efficacy using pain self efficacy questionnaire, pain pain management strategies using coping strategy questionnaire, 10m walking test, and isometric muscle strength at pre-operation and post-operation 5weeks

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	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Control group: rehabilitation alone (60 min/day, 6 times/week)
Interventions/Control_2	Intervention group 1: combined rehabilitation and group-style pain management education (5 sessions of 1 hour/session for a total of 5 weeks)
Interventions/Control_3	Intervention group 2: combined rehabilitation and group-style and video use pain management education (3 sessions of about 15 minutes per video, viewed preoperatively, 3 weeks postoperatively, and 5 weeks postoperatively)
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	40 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
Target sample size	195

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Deguchi
Organization	Fukuoka rehabilitation hospital
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 rehabilitation hospital
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	https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2913-5
Publication of results	Partially published

Result
URL related to results and publications	https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2913-5
Number of participants that the trial has enrolled	98
Results	After propensity score matching, 52 pairs of patients were extracted. In the intervention group, 46 patients completed the PNE. In total, 44 patients in the intervention group and 52 patients in the control group were analyzed. Five weeks following surgery, the rehabilitation itself had also significantly decreased catastrophizing, and the difference between the two groups had only a small effect size(d=0.44).
Results date posted	2021 Year 11 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The baseline demographics and knee symptom characteristics of the patients in the intervention and control groups before and after the propensity score-matching analysis. There were significant differences in age and complications before study enrollment between the two groups, but no significant differences were present after adjustment.
Participant flow	Of the 266 screened patients who underwent HTO, 197 patients were eligible and agreed to enroll in this study. Of these 197 patients, 119 had a PCS score of >21 and thus qualified for the current study. These patients were then pseudo-randomized into each group by a propensity score-matching analysis, resulting in 52 patients in the intervention group and 52 patients in the control group. Eight patients in the intervention group were excluded from the analysis.
Adverse events	no
Outcome measures	Pain catastrophizing scale, pain self-efficacy Questionnaire, isometric knee extension strength, and 10-m walking test
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
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	2019 Year 03 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	2021 Year 11 Month 18 Day

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