UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057703 |
|---|---|
| Receipt number | R000065880 |
| Scientific Title | Preoperative factors associated with resting and walking pain following total hip arthroplasty. |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/04/23 23:25:09 |
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Basic information
Public title
A study on factors associated with postoperative pain following total hip arthroplasty.
Acronym
Pain-related factors in total hip arthroplasty.
Scientific Title
Preoperative factors associated with resting and walking pain following total hip arthroplasty.
Scientific Title:Acronym
PAP-THA study
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of psychological factors, pain sensitivity, and central sensitization (enhanced global pain sensitivity) on postoperative hip pain following total hip arthroplasty in patients with osteoarthritis of the hip.
Basic objectives2
Others
Basic objectives -Others
Investigation of the association between preoperative hip pain (resting and walking pain) and preoperative assessment variables.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting and walking pain (VAS) at 4 and 8 weeks postoperatively
Key secondary outcomes
Pain sensitivity (PPT)
Physical function such as gait speed, joint range of motion, and muscle strength
Pain-related quality of life (McGill Pain Questionnaire)
Psychological factors such as PCS, TSK, and CSI
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving primary THA for hip osteoarthritis
Key exclusion criteria
Secondary osteoarthritis of the hip due to conditions such as femoral head necrosis
Osteoarthritis of the hip caused by autoimmune diseases such as rheumatoid arthritis
Cases with a history of contralateral total hip arthroplasty
Cases undergoing revision total hip arthroplasty (THA)
Cases with postoperative infection
History of neurological disorders causing pain or numbness
Cases in which rehabilitation therapy was discontinued for more than one week due to postoperative complications such as deep vein thrombosis (DVT)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Self-funded resources
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kurume University health care & medical ethics
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942-31-7200
kcrc_jimu@kurume-u.ac.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
| 2025 | Year | 04 | Month | 23 | 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
92
Results
This retrospective observational study investigated preoperative factors associated with postoperative hip pain following total hip arthroplasty (THA) in 92 patients. Pain Catastrophizing Scale (PCS) was identified as a significant factor for postoperative pain at rest, while Central Sensitization Inventory (CSI) and preoperative walking speed (WS) were significant factors for pain during gait. The findings suggest that different preoperative factors are involved in pain at rest and during movement.
Results date posted
| 2025 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were patients with hip osteoarthritis who underwent total hip arthroplasty (THA) at Kurume University Hospital between December 2018 and May 2020. The median age was 67 years (IQR: 60-72), with 14 males and 78 females. The median BMI was 23.6 kg/m2. All surgeries were performed using the posterior approach.
Participant flow
A total of 146 patients who underwent total hip arthroplasty (THA) between December 2018 and May 2020 were initially enrolled. Patients with inflammatory arthritis, osteonecrosis, fracture, malignancy, infection, bilateral THA, cognitive or neurological disorders interfering with evaluation, and those without postoperative pain data were excluded. Finally, 92 patients were included in the analysis.
Adverse events
This was a retrospective observational study, and no adverse events related to the study occurred.
Outcome measures
The primary outcome was hip pain at 4 and 8 weeks postoperatively, assessed using the Visual Analog Scale (VAS) during rest and walking.
Secondary outcomes included associations with preoperative psychological factors (Pain Catastrophizing Scale [PCS], Central Sensitization Inventory [CSI], Tampa Scale for Kinesiophobia [TSK]), pain sensitivity (pressure pain threshold, PPT), preoperative VAS, and gait speed (10-meter walk test).
PPT was assessed at seven sites: the fingernail of the dominant index finger, the second metacarpal bone, the midpoint between the superior angle of the scapula and the spine, the midpoint between the spine and the Jacoby line, the triceps surae on the surgical side, the second dorsal interosseous muscle, and the toenail of the great toe.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study involving patients who underwent total hip arthroplasty (THA) at our institution. Patients with available VAS (Visual Analog Scale) scores for resting and walking pain at one week postoperatively will be included.
Preoperative assessments include pain sensitivity indicators (Quantitative Sensory Testing: QST, Conditioned Pain Modulation: CPM) and psychological factors (Pain Catastrophizing Scale: PCS, Central Sensitization Inventory: CSI).
Data will be retrospectively collected from electronic medical records and assessment sheets. The relationship between these preoperative factors and postoperative pain will be analyzed using multivariate statistical methods.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065880
