UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052076 |
|---|---|
| Receipt number | R000059439 |
| Scientific Title | Study on the efficacy of conservative treatments on pain relief in patients with symptomatic interphalangeal joint osteoarthritis |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/08/31 21:10:01 |
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Basic information
Public title
Study on the efficacy of conservative treatments on pain relief in patients with painful interphalangeal joint osteoarthritis
Acronym
Conservative treatments for painful digital OA
Scientific Title
Study on the efficacy of conservative treatments on pain relief in patients with symptomatic interphalangeal joint osteoarthritis
Scientific Title:Acronym
Conservative treatments for symptomatic digital OA
Region
| Japan |
Condition
Condition
Osteoarthritis of interphalangeal joints
Classification by specialty
| Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize the short- and medium-term effects of intra-articular injection and joint traction therapy on pain in patients with symptomatic interphalangeal joint OA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pinch strenghth
Key secondary outcomes
Range of motion
Functional assessment measures for upper limb
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. age 20 years or older
2. Patients with a diagnosis of hand OA according to American College of Rheumatology criteria
3. Patients with at least one symptomatic DIP joint, with pain lasting for preceding 6 weeks or longer.
Key exclusion criteria
Patients with any of secondary hand OA, inflammatory arthritis, or other neurological and skeletal disease diagnosis contributing to hand pain
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3613
susumus@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Saito |
Organization
Graduate School of Medicine and Faculty of Medicine, Kyoto University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
606-8507
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3613
Homepage URL
susumus@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Susumu Saito
Funding Source
Organization
Non
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
21
Results
The effect of traction therapy on symptomatic joints in patients with DIP joint OA was assessed over time. A significant increase of two-point pinch strength was observed after 1-month traction and maintained for 6 months. At every time point, the treated digits showed a significantly higher improvement of two-point pinch strength from baseline compared to control digits. The patients showed high adherence to the treatment. At month 6, around 80% of patients spontaneously continued traction therapy.
Results date posted
| 2023 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age was 64.9 (range, 48-74) and female patients were dominant (85%). More than 70% of patients had symptom for more than 1 year.
Participant flow
Adverse events
No adverse events
Outcome measures
Two-point pinch strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 24 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 24 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
The pinch strength of patients who underwent traction therapy at home for one month was observed over time. The contralateral finger served as a control. Twenty-one patients participated in the observational study, and 18 fingers from 13 patients were included in paired comparison analysis. Two-point pinch strength increased significantly at 1 month compared to before treatment and was maintained until 6 months. In comparison with within-subject control, the rate of improvement from before treatment was significantly higher in treated digits. Patient compliance with treatment was good.
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059439
