UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037114 |
|---|---|
| Receipt number | R000042287 |
| Scientific Title | Effect of early postoperative pain management education for high tibial osteotomy patients: a quasi-randomized controlled trial |
| Date of disclosure of the study information | 2019/06/19 |
| Last modified on | 2021/11/18 16:17:16 |
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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
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
degunao722@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation, Fukuoka Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042287
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