UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060061 |
|---|---|
| Receipt number | R000068659 |
| Scientific Title | The Effect of Cold Therapy in the Early Postoperative Period on Pain During Weight-Bearing and Weight-Bearing Ratio in Proximal Femoral Fractures |
| Date of disclosure of the study information | 2025/12/12 |
| Last modified on | 2025/12/12 01:42:15 |
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Basic information
Public title
The Effect of Cold Therapy in the Early Postoperative Period on Pain During Weight-Bearing and Weight-Bearing Ratio in Proximal Femoral Fractures
Acronym
Randomized controlled trial
Scientific Title
The Effect of Cold Therapy in the Early Postoperative Period on Pain During Weight-Bearing and Weight-Bearing Ratio in Proximal Femoral Fractures
Scientific Title:Acronym
Randomized controlled trial
Region
| Japan |
Condition
Condition
Proximal femur fracture (femoral neck fracture, trochanteric fracture)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Proximal femoral fractures are common in the elderly, requiring early weight-bearing and walking initiation postoperatively. Postoperative inflammation and acute pain inhibit weight-bearing on the affected side and delay walking acquisition. Therefore, methods to reduce inflammation and pain while promoting weight-bearing are needed. Icing is considered effective for reducing pain and inflammation, but no reports have examined its effects on weight-bearing rate and walking ability when applied immediately before exercise therapy. This study aimed to clarify the effects of icing immediately before exercise therapy on weight-bearing ratio, weight-bearing pain, motor function, walking ability, and CRP levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The primary outcomes are affected-side weight-bearing ratio and weight-bearing pain (NRS).
Key secondary outcomes
Secondarily, knee extension strength, walking ability (FIM), balance function (FBS), and CRP levels were evaluated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Icing was performed using wet ice made by adding 50 mL of water to 500 g of pure ice. The application site was directly above the wound, and icing was administered for four consecutive days immediately before the start of physical therapy. The intervention frequency was once daily, with each icing session lasting 20 minutes.
Interventions/Control_2
The control group did not perform icing immediately before rehabilitation, but both groups were similarly permitted to use general icing in the ward (for pain management purposes).
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing acute postoperative care who underwent total hip arthroplasty or intramedullary nailing for proximal femoral fractures between April and November 2025.
Key exclusion criteria
Exclusion criteria were defined as having a history of disease in the knee or ankle joint on the operative side, having a disease likely to affect blood data, or having weight-bearing restrictions postoperatively.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Keishin |
| Middle name | |
| Last name | Kobayashi |
Organization
Koshigaya Seiwa hospital
Division name
Rehabilitation Department
Zip code
3430026
Address
Room 204, Charman Kita-Koshigaya 2 4-16-9 Kita-Koshigaya, Koshigaya City, Saitama Prefecture
TEL
09058359691
keishin2525@gmail.com
Public contact
Name of contact person
| 1st name | Keishin |
| Middle name | |
| Last name | Kobayashi |
Organization
Koshigaya Seiwa Hospital
Division name
Rehabilitation Department
Zip code
3430856
Address
4-25-5 Yanaka, Koshigaya-city, Saitama Prefecture
TEL
048-967-2215
Homepage URL
keishin2525@gmail.com
Sponsor or person
Institute
Jousai International University
Institute
Department
Personal name
Keishin Kobayashi
Funding Source
Organization
Jousai International University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koshigaya Seiwa Hospital
Address
4-25-5 Yanaka, Koshigaya-city, Saitama Prefecture
Tel
0489672215
keishin2525@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
埼玉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 12 | 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
48
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068659
