UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041375 |
|---|---|
| Receipt number | R000047236 |
| Scientific Title | Construction of a model for estimating the prognosis of neurological rehabilitation for post-stroke pain |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2024/04/08 14:43:28 |
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Basic information
Public title
Construction of a model for estimating the prognosis of neurological rehabilitation for post-stroke pain
Acronym
Construction of a model for estimating the prognosis of neurological rehabilitation for post-stroke pain
Scientific Title
Construction of a model for estimating the prognosis of neurological rehabilitation for post-stroke pain
Scientific Title:Acronym
Construction of a model for estimating the prognosis of neurological rehabilitation for post-stroke pain
Region
| Japan |
Condition
Condition
Rehabilitation users including other facilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantify the pathological characteristics in 100 post-stroke pain patients by neurophysiology and kinematics, and elucidate the dependence of pain relief by nerve rehabilitation on the pathological characteristics by machine learning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Collection of basic information
Age, gender, name of main disease, date of onset, presence or absence of pain due to joint movement, presence or absence of upper limb subluxation, presence or absence of range of motion, Modified Ashworth Scale (MAS), presence or absence of allodynia
2.Somatosensory evaluation
Semmes-Weinstein Monofilaments Perception Test
3.Pain evaluation questionnaire
PainDETECT
Neuropathic pain inventory (NPI)
Japanese shortened version McGill Pain Questionnaire (SF-MPQ-JV)
4.Psychological evaluation
Japanese shortened version Pain Catastrophizing Scale (PCS-6)
Tampa Scale for Kinesiophobia Japanese version (TSK-11-J)
5.Pain evaluation
Numerical Rating Scale (NRS) at first time, 2 weeks, 1 month, 2 months, 3 months
6.Physical function evaluation
Fugal-Meyer Assessment (FMA) at the first time and 3 months
Key secondary outcomes
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
Those who have pain after stroke due to stroke diagnosis
Key exclusion criteria
1.Those who do not recognize post-stroke pain
2.Those who have pain due to orthopedic diseases
3.Subjects who have difficulty in understanding language instructions due to cognitive decline or higher brain dysfunction, and who have difficulty answering questionnaires.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
https://kawaguchi-ns.com
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Koriencho, Hirakata City, Osaka
Tel
0728351010
kawaguchi.ns.reha@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
川口脳神経外科リハビリクリニック（大阪府）、星ヶ丘医療センター（大阪府）、奈良県総合医療センター（奈良県）、協和会病院（大阪府）、摂南総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ptj/advance-article-abstract/doi/10.1093/ptj/pzae055/7639599?redirectedFrom
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ptj/advance-article-abstract/doi/10.1093/ptj/pzae055/7639599?redirectedFrom
Number of participants that the trial has enrolled
85
Results
cluster 4 (deep muscle pain with pressure sensation). In the cross-sectional analysis, clinical symptoms differed among the subgroups, with differences in the prevalence of arthralgia, limited range of motion, somatosensory disturbance, and allodynia. Longitudinal analysis showed that the prognostic value of pain intensity differed between subgroups. Pain intensity in cluster 4 was significantly relieved, suggesting that conventional exercise-based rehabilitation reduces musculoskeletal pain.
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those who have pain after stroke according to the diagnosis of stroke.
No age limit
Participant flow
In addition to the above participant background (selection criteria), the following exclusion criteria were identified before the evaluation of the survey items described later.
Those who did not have post-stroke pain.
Those with pain due to orthopedic disease
Subjects who have difficulty in understanding verbal instructions due to cognitive decline or higher brain dysfunction, and who have difficulty in answering the questionnaire form.
Adverse events
Procedures to minimize risk are performed by professional proximal monitoring during the exercise evaluation. In addition, risk management criteria prior to and during rehabilitation are in accordance with the Anderson-Dohi criteria. During rehabilitation, the risk is considered low because rehabilitation is performed under medical supervision, including control of physical condition and blood pressure, etc. However, while monitoring the patient's mood and physical condition, the patient should take breaks as necessary, and if the patient complains of discomfort, the patient should stop or seek medical attention (from the clinic director) and receive appropriate treatment. The procedure is designed to minimize the risk of injury.
Outcome measures
Collection of basic information: age, sex, name of main disease, date of onset, presence or absence of pain with joint movement, presence or absence of upper limb subluxation, presence or absence of joint range of motion limitation, Modified Ashworth Scale, presence or absence of allodynia
Somatosensory evaluation
Semmes-Weinstein Monofilaments Perception Test
Pain assessment questionnaire PainDETECT
Neuropathic pain inventory
McGill Pain Questionnaire (Japanese abbreviated version)
Psychological assessment
Japanese abbreviated version of Pain Catastrophizing Scale
Tampa Scale for Kinesiophobia Japanese version
Pain assessment
Numerical Rating Scale at the initial visit, 2 weeks, 1 month, 2 months, and 3 months
Physical function assessment
Fugal-Meyer Assessment at the first visit and at 3 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform the following evaluations
1.Collection of basic information
Age, gender, name of main disease, date of onset, presence or absence of pain due to joint movement, presence or absence of upper limb subluxation, presence or absence of range of motion, Modified Ashworth Scale (MAS), presence or absence of allodynia
2.Somatosensory evaluation
Semmes-Weinstein Monofilaments Perception Test
3.Pain evaluation questionnaire
PainDETECT
Neuropathic pain inventory (NPI)
Japanese shortened version McGill Pain Questionnaire (SF-MPQ-JV)
4.Psychological evaluation
Japanese shortened version Pain Catastrophizing Scale (PCS-6)
Tampa Scale for Kinesiophobia Japanese version (TSK-11-J)
5.Pain evaluation
Numerical Rating Scale (NRS) at first time, 2 weeks, 1 month, 2 months, 3 months
6.Physical function evaluation
Fugal-Meyer Assessment (FMA) at the first time and 3 months
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047236
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