UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062260 |
|---|---|
| Receipt number | R000071243 |
| Scientific Title | Effects of Postoperative Dressings After Carpal Tunnel Release |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/16 20:09:48 |
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Basic information
Public title
Effects of Postoperative Dressings After Carpal Tunnel Release
Acronym
Effects of Postoperative Dressings After Carpal Tunnel Release
Scientific Title
Effects of Postoperative Dressings After Carpal Tunnel Release
Scientific Title:Acronym
Effects of Postoperative Dressings After Carpal Tunnel Release
Region
| Japan |
Condition
Condition
Carpal tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare postoperative swelling and functional outcomes between patients treated with a compression dressing combined with cast immobilization and those treated with a bulky dressing by an elastic bandage after carpal tunnel release.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hand circumference at 1 week postoperatively, measured using the figure-of-eight method.
Key secondary outcomes
Hand circumference at 1 and 3 months postoperatively; finger circumference, key pinch strength, finger total active flexion, wrist range of motion, and the Carpal Tunnel Syndrome Symptom Severity Scale and Functional Status Scale at 1 week, 1 month, and 3 months postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
Compression dressing with a forearm cast
Interventions/Control_2
Bulky dressing by an elastic bandage
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with carpal tunnel syndrome who were scheduled to undergo mini-open carpal tunnel release and provided written informed consent.
Key exclusion criteria
Rheumatoid arthritis
Maintenance hemodialysis
Dupuytren disease
Pre-existing deformity or functional impairment of the affected upper extremity
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Hosokawa |
Organization
Kiryu Orthopaedic Surgery Hospital
Division name
Orthopedic
Zip code
3760011
Address
1-253-1, Aioi-machi, Kiryu, Gunma
TEL
0277402600
thosokawa310@gmail.com
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Hosokawa |
Organization
Kiryu Orthopaedic Surgery Hospital
Division name
Orthopedic
Zip code
3760011
Address
1-253-1, Aioi-machi, Kiryu, Gunma
TEL
0277402600
Homepage URL
thosokawa310@gmail.com
Sponsor or person
Institute
Tone Chuo Hospital
Institute
Department
Personal name
Takafumi Hosokawa
Funding Source
Organization
None
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
Tone Chuo Hospital
Address
910-1, Numasu-machi, Numata, Gunma
Tel
0278224321
kazuki.maruyama@tonehoken.or.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
利根中央病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Protocol not publicly available.
Publication of results
Unpublished
Result
URL related to results and publications
Results are not publicly available outside the UMIN-CTR.
Number of participants that the trial has enrolled
35
Results
At 1 week, hand circumference tended to be greater in the forearm cast group than in the bulky dressing group, but the difference was not significant (P=0.062). No between-group differences were found in other outcomes, except that thumb total active flexion at 1 month was greater in the bulky dressing group. No serious adverse events occurred.
Results date posted
| 2026 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-five patients (39 hands) with carpal tunnel syndrome were enrolled. Three patients (3 hands) withdrew before analysis, leaving 32 patients (36 hands) for the final analysis. The baseline demographic and clinical characteristics, including age and sex, were comparable between the two groups.
Participant flow
Thirty-five patients (39 hands) were enrolled and allocated to the compression dressing with forearm cast group (19 hands) or the bulky dressing group (20 hands). Before analysis, 2 hands in the compression dressing with forearm cast group and 1 hand in the bulky dressing group were excluded. Finally, 32 patients (36 hands), comprising 17 hands in the compression dressing with forearm cast group and 19 hands in the bulky dressing group, were included in the analysis.
Adverse events
None
Outcome measures
Primary outcome
At 1 week postoperatively, the forearm cast group showed a trend toward greater hand circumference than the bulky dressing group; however, the difference was not statistically significant (P = 0.062).
Secondary outcomes
No significant between-group differences were observed in hand circumference at 1 and 3 months postoperatively, finger circumference, key pinch strength, total active flexion of the fingers excluding the thumb, wrist range of motion, Symptom Severity Scale, or Functional Status Scale. In contrast, thumb total active flexion at 1 month postoperatively was significantly greater in the bulky dressing group.
Adverse events
No serious adverse events were observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 10 | 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 | 16 | Day |
Last modified on
| 2026 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071243
