UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015003 |
|---|---|
| Receipt number | R000017448 |
| Scientific Title | Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2014/08/31 |
| Last modified on | 2021/09/05 12:49:37 |
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Basic information
Public title
Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial
Acronym
Efficacy of OT after Operation of DRF
Scientific Title
Efficacy of Occupational Therapy after Volar Locking Plate Fixation of the Distal Radius Fracture: A Randomized Controlled Trial
Scientific Title:Acronym
Efficacy of OT after Operation of DRF
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of occupationa therapy after volar locking plate fixation of distal radius fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quick Disability of Arm, Shoulder, and Hand (QuickDASH) score after 6 weeks
Key secondary outcomes
Range of motion of the wrist and the forearm, Grip strength, Pinch strength, Patient-Rated Wrist Evaluation (PRWE), Pain evaluated by Visual Analogue Scale(VAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Occupational therapy (2 times/week, during the twelve weeks after surgery) and home exercise instruction by the attending doctor at every visit.
Interventions/Control_2
Home exercise instruction by the attending doctor at every visit.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients who have a distal radius fracture to open reduction and internal fixation with volar locking plate.
2) Patients 40 years of age or over at the time of providing consent.
3) Patients who could provide written consent for participation.
Key exclusion criteria
1) Patients with a history of a distal radius fracture.
2) Patients with complex regional pain syndrome.
3) Patients with a connective tissue disease.
4) Patients who are deemed unsuitable by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Gamo |
Organization
Bellland General Hospital
Division name
Orthopaedic Surgery
Zip code
599-8247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 599-8247, Japan
TEL
072-234-2001
kaz-gamo@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazushige |
| Middle name | |
| Last name | Gamo |
Organization
Bellland General Hospital
Division name
Orthopaedic Surgery
Zip code
599-8247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 599-8247, Japan
TEL
072-234-2001
Homepage URL
kaz-gamo@umin.ac.jp
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Bellland general hospital, IRB
Address
500-3 higashiyama, naka-ku, sakai, Osaka, Japan
Tel
072-234-2001
kaz-gamo@umin.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
ベルランド総合病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jhandsurg.org/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jhandsurg.org/
Number of participants that the trial has enrolled
256
Results
The QuickDASH scores were significantly lower in the OT group at 6 weeks post-surgery (12.5 vs. 19.4). The postoperative VAS pain scores were significantly lower in the OT group at 2, 4, and 6 weeks (10.2 vs. 17.6). The active ROM of the wrist flexion-extension arc at 2, 4, 6, and 8 weeks, active ROM of the pronation-supination arc at 6 and 8 weeks, and passive ROM of the wrist flexion-extension arc at 2, 4, and 8 weeks were significantly greater in the OT group.
Results date posted
| 2021 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female patients older than 40 years with distal radius fracture and who underwent volar plate fixation between September 2014 and May 2018 were included in this prospective, two-arm, parallel-group, randomized controlled trial. Patients with polytrauma, open fracture, ulnar head fracture excluding ulnar styloid fracture, ipsilateral extremity fracture, present or previous fracture to the contralateral side, history of complex regional pain syndrome, collagen vascular disease, or limited cognitive capacity were excluded.
Participant flow
Fifty-seven patients diagnosed with distal radius fractures who had undergone volar plate fixation were enrolled in a prospective randomized controlled trial. Patients were randomised into the OT and independent exercise (IE) groups, in which they exercised independently under the surgeon's direction wit and without OT, respectively. The primary outcome was the functional outcome measured using the Quick Disability of Arm, Shoulder, and Hand (QuickDASH) questionnaire after 6 weeks. The secondary outcomes were functional outcomes measured using the Patient-rated Wrist Evaluation questionnaire, active and passive ranges of motion (ROMs), grip strength, key pinch strength, and pain measured on a visual analog scale (VAS). Patients were followed up in the outpatient department at 2, 4, 6, and 8 weeks and at 3 and 6 months.
Adverse events
none
Outcome measures
The main outcome measure was the functional outcome measured using the Quick Disability of Arm, Shoulder, and Hand (QuickDASH) questionnaire after 6 weeks. The secondary outcomes were functional outcomes measured using the Patient-rated Wrist Evaluation (PRWE) questionnaire, active and passive ROMs, grip strength, key pinch strength, and pain measured on a visual analog scale (VAS).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017448
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