UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062112 |
|---|---|
| Receipt number | R000070272 |
| Scientific Title | Prevention of peRsistent postoperative pain through mEntal Practice in Knee Osteoarthritis |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/07/01 20:02:14 |
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Basic information
Public title
Effectiveness of mental practice in preventing persistent postoperative pain in patients with knee osteoarthritis
Acronym
PREP-Knee Study
Scientific Title
Prevention of peRsistent postoperative pain through mEntal Practice in Knee Osteoarthritis
Scientific Title:Acronym
PREP-KOA Trial
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surgical treatment is sometimes selected for patients with knee osteoarthritis (KOA). However, among patients who undergo surgery, some experience persistent pain that becomes chronic postoperatively, resulting in persistent postoperative pain. In recent years, psychosocial factors related to pain perception have been identified as contributing to the development of persistent postoperative pain. However, no effective treatment targeting these factors has yet been established, making this issue an urgent clinical challenge.
Mental practice (MP) has been reported to be effective as an intervention targeting psychosocial factors associated with pain in patients with chronic pain, and this approach is considered to have sufficient potential for application to persistent postoperative pain. Therefore, the present study aims to develop an MP program for the prevention of persistent postoperative pain in patients following surgery for KOA and to examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Pain intensity (Numerical Rating Scale [NRS]); pain catastrophizing (Pain Catastrophizing Scale [PCS]) and anxiety/depression (Hospital Anxiety and Depression Scale [HADS]) as assessments of psychosocial factors; temporal summation of pain (TSP) and conditioned pain modulation (CPM) as other related measures.
Key secondary outcomes
Range of motion; lower extremity muscle strength (30-second Chair Stand Test [CS-30]); and walking ability (10-m walking time).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions: Tablet-based MP with electrical stimulation + standard physical therapy
Interventions/Control_2
Control: Standard physical therapy
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis who are scheduled to undergo an around-the-knee osteotomy (AKO) or total knee arthroplasty (TKA) at participating institutions and are undergoing their first unilateral surgery.
Key exclusion criteria
Exclusion criteria: cognitive impairment (HDS-R score < 20), clinically significant neurological or musculoskeletal disorders affecting outcome measurements, and severe cardiac or respiratory disease limiting exercise performance.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Medical corporation Wajinkai Hospital
Division name
Department of Rehabilitation
Zip code
851-0103
Address
96 Nakazato, Nagasaki, Japan
TEL
0958392051
takashi_net184@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagasaki University
Division name
Graduate School of Biomedical Sciences, Health Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197994
Homepage URL
takashi_net184@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Takashi Hasegawa
Funding Source
Organization
Japan Science and Technology Agency
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
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197994
takashi_net184@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
長崎県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 01 | 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
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070272
