UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041720 |
|---|---|
| Receipt number | R000046532 |
| Scientific Title | Effects of a self-management program combined with pain neuroscience education on physical activity and sedentary behavior in patients with knee pain: a preliminary trial |
| Date of disclosure of the study information | 2020/09/08 |
| Last modified on | 2020/09/08 06:55:43 |
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Basic information
Public title
Effects of a self-management program combined with pain neuroscience education on physical activity and sedentary behavior in patients with knee pain: a preliminary trial
Acronym
Effects of a Pain neuroscience education-based self-management program on sedentary behavior in patients with knee pain
Scientific Title
Effects of a self-management program combined with pain neuroscience education on physical activity and sedentary behavior in patients with knee pain: a preliminary trial
Scientific Title:Acronym
Effects of a Pain neuroscience education-based self-management program on sedentary behavior in patients with knee pain
Region
| Japan |
Condition
Condition
Chronic Knee Pain patients
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of self-management programs on physical activity in patients with chronic knee pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-management program and Physical therapy
Interventions/Control_2
Physical therapy
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients Knee osteoarthritis and their postoperative who meet the Kellgren-Laurence classification criteria of the American College of Rheumatology Society
Key exclusion criteria
(1) Those who do not agree to participate in the study, (2) Those who have no knee pain or are under 3 months old, (3) Those who have systemic arthritis, (4) History of knee fracture or malignant tumor. Some people, (5) people who have difficulty walking on their own, (6) people with psychiatric disorders such as schizophrenia, (7) people with neurological conditions such as Parkinson's disease, multiple sclerosis, and stroke, (8) Those who have difficulty understanding the surveys and interventions involved in this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | deguchi |
| Middle name | naoki |
| Last name | naoki |
Organization
Fukuoka Reha Orthopedics Clinic
Division name
Department of Rehabilitation
Zip code
819-8551
Address
7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka 819-8551, Japan.
TEL
092-812-1555
degunao722@yahoo.co.jp
Public contact
Name of contact person
| 1st name | deguchi |
| Middle name | naoki |
| Last name | naoki |
Organization
Fukuoka Reha Orthopedics Clinic
Division name
Department of Rehabilitation
Zip code
819-8551
Address
7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka 819-8551, Japan.
TEL
092-812-1555
Homepage URL
degunao722@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Reha Orthopedics Clinic
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Reha Orthopedics Clinic
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
Fukuoka Rehabilitation Hospital
Address
7-220 Nokata, Nishi-ku, Fukuoka-shi, Fukuoka 819-8551, Japan.
Tel
092-812-1555
degunao722@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
FRH2017-R-007
Org. issuing International ID_1
Fukuoka Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
44
Results
Results of the main analysis showed no difference in the medium- and high-intensity physical activity (METs/min/week) between groups (305, 95% CI -70, 681). On the other hand, there was a moderate reduction in sedentary time to 190 minutes (95% CI -262, -116, d=0.78) in the intervention group compared to the control group. The secondary outcomes of WOMAC pain (p=0.264, d=0.33), exercise self-efficacy (p=0.940, d=0.02), and subjective health (p=0.645, d=0.13) did not differ between groups.
Results date posted
| 2020 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The majority of the sexes were female, with a mean BMI of less than 24.0 kg/m2 and few obese individuals. The rate of open blood therapy was 60% in both groups. There was no significant difference in all items; the mean attendance of the SMP was 7.1 out of 9 sessions (2.4 standard deviation) for a 78.8% attendance rate.
Participant flow
Of the 60 participants who were assessed for eligibility for the study, 44 (85.4%) met the inclusion and exclusion criteria. Forty-four participants were included in the study, 24 in the intervention group and 20 in the control group who did not wish to take the SMP. The number of dropouts during the intervention period was 7 (15.9%), of which 1 was surgery for complications, 4 for health reasons other than knee disease, and 2 for unknown, with no adverse events reported. A comparison of the patient characteristics of the intervention and control groups in the analyzed subjects and each outcome before the intervention is shown in Table 2.The mean attendance of the SMP was 7.1 out of 9 (with a standard deviation of 2.4) for a 78.8% attendance rate.
Adverse events
no
Outcome measures
Self-reported moderate intensity physical activity and sedentary behavior, Pain, exercise self-efficacy, and subjective health
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046532
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