UMIN-CTR Clinical Trial

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
Email	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
Email	kaz-gamo@umin.ac.jp

Sponsor
Institute	Bellland General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017448