UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026156 |
|---|---|
| Receipt number | R000030059 |
| Scientific Title | Investigation of relationship between pain and hesitation of movement initiation in acute phase after surgery |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2023/08/23 11:00:36 |
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Basic information
Public title
Investigation of relationship between pain and hesitation of movement initiation in acute phase after surgery
Acronym
Relationship between pain and hesitation of movement initiation
Scientific Title
Investigation of relationship between pain and hesitation of movement initiation in acute phase after surgery
Scientific Title:Acronym
Relationship between pain and hesitation of movement initiation
Region
| Japan |
Condition
Condition
postoperative patients with orthopedics
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hesitation of movement initiation are observed in clinical practice for patients with musculoskeletal pain. However, it is unclear whether subjective pain intensity induced such hesitation. We investigated a relationship between the pain and hesitation of movement initiation for patients after surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain at rest, pain at movement, emotional of pain, movement velocity, hesitate of movement initiation, magnitude of movement
Key secondary outcomes
functional test
range of motion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Upper of limb fracture
Key exclusion criteria
stroke, parkinson's disease, multiple sclerosis, neuropathy, chronic pain
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | RYOTA |
| Middle name | |
| Last name | IMAI |
Organization
Osaka Kawasaki Rehabilitation University,
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City, Osaka 597-0104, Japan.
TEL
0745541601
ryo7891@gmail.com
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | IMAI |
Organization
Osaka Kawasaki Rehabilitation University,
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City, Osaka 597-0104, Japan.
TEL
0745541601
Homepage URL
ryo7891@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Osaka Kawasaki Rehabilitation University
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
Osaka Kawasaki Rehabilitation University
Address
158 Mizuma, Kaizuka City, Osaka 597-0104, Japan.
Tel
0745-54-1601
ryo7891@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32865035/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32865035/
Number of participants that the trial has enrolled
30
Results
Pain intensity did not significantly correlate with movement outcome. A pronounced correlation was identified between the fear of movement and parameters such as velocity and movement hesitation time. Hesitation at 1 day postsurgery was significantly correlated with the DASH score at 30 days. Velocity at 7 days postsurgery was significantly correlated with the DASH score at 30 days, and the velocity at 14 days postsurgery was significantly correlated with the DASH score at 30 days.
Results date posted
| 2023 | Year | 08 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were postoperative patients with distal radius fractures.
Patients were excluded if they had: (1) severe chronic uncontrolled pain at a site other than the surgical wrist before the surgery; (2) stroke or other central nervous system disorder; or (3) a fracture other than distal radius fractures.
Twenty patients fulfilled the criteria, mean age was 69.7, SD was 10.2. Women were 18.
Participant flow
Written informed consent was procured from patients who were subjected to surgical procedures following their hospital admission.
Adverse events
None
Outcome measures
Pain intensity (both pain at rest and movement pain) was assessed on a visual analogue scale (VAS: 0 = no pain; 100 = highest possible degree of pain). Fear of movement was also assessed by a VAS (0 = no fear; 100 = highest possible degree of fear).We used the the Disabilities of the Arm, Shoulder, and Hand Questionnaire to assess the motor function of the wrist.
Movement characteristics were assessed by means of a finger tapping task. We measures the distance between the thumb and index finger and calculates the peak velocity, the peak amplitude of the opening between the thumb and index finger, and the duration of movement-initiation hesitation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
recorded with an equipment video camera or used sensor.
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030059
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