UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058531 |
|---|---|
| Receipt number | R000066932 |
| Scientific Title | A Randomized Controlled Trial on the Effectiveness of Rehabilitation Interventions for the Prevention of Chronic Postsurgical Pain After Periarticular Knee Osteotomy |
| Date of disclosure of the study information | 2025/07/21 |
| Last modified on | 2025/07/21 11:32:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of Rehabilitation Interventions for the Prevention of Chronic Pain After Periarticular Knee Osteotomy
Acronym
Effectiveness of Rehabilitation Interventions for Preventing Chronic Pain After Periarticular Knee Osteotomy
Scientific Title
A Randomized Controlled Trial on the Effectiveness of Rehabilitation Interventions for the Prevention of Chronic Postsurgical Pain After Periarticular Knee Osteotomy
Scientific Title:Acronym
Rehabilitation RCT for Preventing Chronic Pain After Knee Osteotomy
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the preventive effect of wearable transcutaneous electrical nerve stimulation (TENS) on chronic post-surgical pain (CPSP) following around the knee osteotomy (AKO). The intervention involves the application of TENS from the early postoperative period at the initiation of weight-bearing, aiming to alleviate pain during weight-bearing and walking.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome will be pain intensity at 1 year postoperatively, and between-group comparisons will be conducted using a mixed-effects model. Additionally, a complete case analysis will be performed as a sensitivity analysis.
Key secondary outcomes
Secondary outcomes include quadriceps muscle strength, pressure pain thresholds at the affected and unaffected sites, two-point discrimination, and gait analysis (varus thrust).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the intervention group, rehabilitation combined with a wearable transcutaneous electrical nerve stimulation (TENS) device will be performed for 3 weeks, starting from postoperative day 15 at the initiation of weight-bearing.
Interventions/Control_2
In the control group, sham TENS without electrical stimulation will be applied for 3 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study targets patients undergoing proximal tibial osteotomy (PTO) for knee osteoarthritis.
Key exclusion criteria
Patients with osteonecrosis, posterior root tears of the medial meniscus, neuromuscular diseases, or similar conditions will be excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Tanaka |
Organization
Fukuoka Orthopaedic Hospital
Division name
Clinical Research Center
Zip code
8150063
Address
2-10-50 Yanagochi, Minami-ku, Fukuoka, Fukuoka, Japan.
TEL
0925121836
loose_no_6@ybb.ne.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Tanaka |
Organization
Fukuoka Orthopaedic Hospital
Division name
Clinical Research Center
Zip code
8150063
Address
2-10-50 Yanagochi, Minami-ku, Fukuoka, Fukuoka, Japan.
TEL
0925121836
Homepage URL
loose_no_6@ybb.ne.jp
Sponsor or person
Institute
Department of Clinical Research Center, Fukuoka Orthopaedic Hospital, Fukuoka, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Research Center, Fukuoka Orthopaedic Hospital, Fukuoka, Japan
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
Institutional Review Board (IRB), Fukuoka Orthopaedic Hospital
Address
2-10-50 Yanagochi, Minami-ku, Fukuoka, Fukuoka, Japan.
Tel
0925121836
loose_no_6@ybb.ne.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
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066932
