UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063137 |
|---|---|
| Receipt number | R000072243 |
| Scientific Title | Intensity-specific associations between pain self-efficacy and accelerometer-measured physical activity and the mediating role of pain catastrophizing in patients with chronic pain: a cross-sectional study |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/10/01 21:28:54 |
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Basic information
Public title
A study on the relationship between confidence in daily activities despite pain and physical activity in people with chronic pain
Acronym
Confidence and activity in chronic pain study
Scientific Title
Intensity-specific associations between pain self-efficacy and accelerometer-measured physical activity and the mediating role of pain catastrophizing in patients with chronic pain: a cross-sectional study
Scientific Title:Acronym
Pain self-efficacy and physical activity in chronic pain
Region
| Japan |
Condition
Condition
chronic pain patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to clarify the association between pain self-efficacy and objectively measured, accelerometer-based physical activity, distinguished into moderate-to-vigorous physical activity and light physical activity, in patients with chronic pain. The secondary aim is to examine whether pain catastrophizing plays a mediating role in the association between pain self-efficacy and moderate-to-vigorous physical activity.
Basic objectives2
Others
Basic objectives -Others
Exploration of factors associated with physical activity in patients with chronic pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily time spent in moderate-to-vigorous physical activity (3.0 METs or more) and light physical activity (1.5 to 2.9 METs), measured with a triaxial accelerometer (Active style Pro HJA-750C; Omron Healthcare Co., Ltd., Kyoto, Japan).
Key secondary outcomes
Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ), pain catastrophizing (Pain Catastrophizing Scale, PCS), kinesiophobia (Tampa Scale for Kinesiophobia, TSK), pain-related disability (Pain Disability Assessment Scale, PDAS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), and pain intensity (Numerical Rating Scale, NRS).
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pain persisting for 3 months or longer
Cognitive function sufficient to complete the questionnaires
No restriction was placed on the site or diagnosis of pain, and patients with chronic pain at any body region were eligible.
Key exclusion criteria
Pain duration of less than 3 months
Evident acute pain, such as that caused by trauma
Difficulty with communication
Inability to obtain consent from the patient or the patient's family
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kawai |
Organization
Terada Pain Clinic
Division name
Department of Rehabilitation
Zip code
430-0906
Address
1-24-1, Sumiyoshi, Chuo-ku, Hamamatsu, Shizuoka, 430-0906, Japan
TEL
053-476-1115
20mr03@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kawai |
Organization
Terada Pain Clinic
Division name
Department of Rehabilitation
Zip code
430-0906
Address
1-24-1, Sumiyoshi, Chuo-ku, Hamamatsu, Shizuoka, 430-0906, Japan
TEL
053-476-1115
Homepage URL
20mr03@g.seirei.ac.jp
Sponsor or person
Institute
Terada Pain Clinic
Institute
Department
Personal name
Funding Source
Organization
self-funded
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
Ethics Committee of Seirei Christopher University
Address
3453 Mikatahara, Chuo-ku, Hamamatsu, Shizuoka, 433-8558, Japan
Tel
+81-53-439-1400
kazuhiro-k@seirei.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
154
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
In this non-interventional cross-sectional study, participants wore a triaxial accelerometer (Active style Pro HJA-750C; Omron Healthcare Co., Ltd., Kyoto, Japan) at the waist for at least two weeks. Data were considered valid if the device was worn for 600 minutes or more per day on at least four days. From these valid data, we calculated daily step counts and the time spent in moderate-to-vigorous physical activity (3.0 METs or more), light-intensity physical activity (1.5 to 2.9 METs), and sedentary behavior (1.5 METs or less). Additionally, self-administered questionnaires were used to assess pain self-efficacy (Pain Self-Efficacy Questionnaire [PSEQ]), pain catastrophizing (Pain Catastrophizing Scale [PCS]), kinesiophobia (Tampa Scale for Kinesiophobia [TSK]), pain-related disability (Pain Disability Assessment Scale [PDAS]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), and pain intensity (Numeric Rating Scale [NRS]).
Management information
Registered date
| 2026 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072243
