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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041720
Receipt No. 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

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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
Email 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
Email degunao722@yahoo.co.jp

Sponsor
Institute Fukuoka Reha Orthopedics Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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