Chronic PainMLA-MMNCT07693062
Multimodal Lifestyle Approach for Chronic Pain With Nociplastic Pain Features
A study testing Multimodal Lifestyle Approach Using a Pain Education Booklet in people with Chronic Pain and Nociplastic Pain, run by Prefectural University of Hiroshima at 2 sites in Japan.
Trial summary
This single-center, single-arm pilot feasibility study aims to examine the feasibility and preliminary effectiveness of an intervention program using a pain education booklet based on a multimodal lifestyle approach for patients with chronic pain with features of nociplastic pain. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Pain, Nociplastic Pain
- What is being tested?
- Multimodal Lifestyle Approach Using a Pain Education Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving rehabilitation services at the study site.
- Aged 20 to 75 years.
- Chronic pain lasting for at least 3 months.
- Pain intensity of 3 or higher on an 11-point Numerical Rating Scale.
- Suspected involvement of nociplastic pain, assessed using a screening procedure based on clinical criteria and grading for chronic nociplastic pain affecting the musculoskeletal system.
- Able and willing to provide written informed consent.
- Screening Procedure for Nociplastic Pain Features The involvement of nociplastic pain features will be assessed before enrollment using a structured screening form developed by the research group based on the clinical criteria and grading system for chronic nociplastic pain affecting the musculoskeletal system proposed by Kosek et al. The screening form is not intended to establish a definitive diagnosis of nociplastic pain, but to identify patients with suspected nociplastic pain features for eligibility.
- The screening procedure includes assessment of pain duration, pain distribution, possible nociceptive and neuropathic pain mechanisms, hyperalgesia or allodynia, history of hypersensitivity, and comorbid symptoms related to central sensitization. The screening algorithm and assessment items will be documented in the study materials to improve transparency and reproducibility.
Who cannot join
- Presence of specific pain-related conditions or symptoms, including fracture, rheumatic disease, musculoskeletal surgery within the past 3 years, fibromyalgia, or complex regional pain syndrome.
- Inability to follow the study schedule.
- Receiving compensation for absence from work due to a traffic accident or work-related injury.
- Difficulty using Japanese.
- Cognitive impairment that may affect the assessment procedures or pain education.
- Possibility of pregnancy during the study period.
- Previous experience of Pain Neuroscience Education.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites
SKY Clinic
Ibaraki, Osaka, 567-0829
Hirofumi Yamashita, MSc, +81 72 638 7676, yamashita.hf@gmail.com
Prefectural University of Hiroshima
Mihara, Hiroshima, 725-0053
Tomohiko Nishigami, Professor, +81 848-60-1120, tomon@pu-hiroshima.ac.jp
About this study
Official title: Intervention Using a Multimodal Lifestyle Approach for Patients With Chronic Pain Showing Nociplastic Pain Features: A Single-Arm Pilot Feasibility Study
This single-center, single-arm pilot feasibility study aims to examine the feasibility and preliminary effectiveness of an intervention program using a pain education booklet based on a multimodal lifestyle approach for patients with chronic pain with features of nociplastic pain. Participants will receive pain education and self-management support using a booklet developed by the investigators, together with exercise therapy provided as part of usual outpatient rehabilitation. The intervention includes pain science education, shared decision-making, goal setting, physical activity and exercise, sleep, stress management, diet, work environment, headache-related lifestyle factors, and strategies for recovery-oriented and sustainable activities. Feasibility outcomes include recruitment and consent rates, intervention completion rate, assessment completion rate, participant satisfaction, reasons for dropout, adverse events, and practical difficulties during implementation. Preliminary effectiveness will be explored using patient-reported outcomes and physical function measures at baseline, 6 weeks, and 12 weeks.
Read the detailed description
Chronic pain has a substantial impact on activities of daily living, quality of life, work participation, and socioeconomic burden. Chronic pain is understood within a biopsychosocial framework, and modifiable lifestyle factors such as sleep, stress, physical activity, and exercise may contribute to the persistence or exacerbation of pain. In recent years, nociplastic pain has been recognized as an important mechanism in some patients with chronic pain that cannot be fully explained by nociceptive or neuropathic pain alone. Nociplastic pain may be associated with widespread pain, hyperalgesia, sleep disturbance, fatigue, mood and cognitive symptoms, and sensory hypersensitivity. A multimodal lifestyle approach, which combines pain education with individualized support for lifestyle factors such as physical activity, exercise, sleep, and stress management, may be useful for patients with chronic pain showing nociplastic pain features. Therefore, this study will evaluate the feasibility and preliminary effectiveness of a booklet-based multimodal lifestyle intervention in an outpatient clinical setting. This initial feasibility study will focus on a general outpatient chronic pain population with suspected nociplastic pain features, while excluding specific or complex pain-related conditions that may require specialized management. As this is a single-arm pilot feasibility study delivered within usual outpatient rehabilitation, preliminary effectiveness outcomes will be interpreted exploratorily and will not be used to estimate causal effects. The findings will inform the feasibility, acceptability, and design of a future controlled trial.
- Conditions
- Chronic Pain, Nociplastic Pain
- Being tested
- Multimodal Lifestyle Approach Using a Pain Education Booklet
- Keywords
- Chronic pain, Nociplastic pain, Multimodal lifestyle approach
- Medical subject headings
- Chronic Pain, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Lifestyle Approach Using a Pain Education BookletBehavioural
Participants will receive booklet-based pain education and self-management support using a multimodal lifestyle approach, together with exercise therapy as part of usual outpatient rehabilitation. The intervention will be delivered once per week for 12 weeks, with each session lasting approximately 40 minutes. Core components include goal setting, shared decision-making, pain science education, lifestyle support, recovery-oriented activities, and exercise or physical activity guidance. The first session will include orientation to the booklet and confirmation of pain-related problems and goals. Subsequent sessions will review understanding, progress, and barriers, and adjust goals or self-management strategies as needed. The physiotherapist may tailor the emphasis, exercise content, and self-management strategies according to each participant's symptoms, goals, and response to rehabilitation. Intervention fidelity will be monitored using session records and a checklist.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Lifestyle Approach | Experimental | Participants in this single-arm study will receive a 12-week booklet-based multimodal lifestyle intervention, together with exercise therapy as part of usual outpatient rehabilitation. The intervention focuses on pain education, goal setting, shared decision-making, lifestyle-related self-management, recovery-oriented activities, and exercise or physical activity guidance. Receives: Behavioral: Multimodal Lifestyle Approach Using a Pain Education Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcome: Consent Rate
The proportion of eligible patients who provide written informed consent to participate in the study. The feasibility criterion for consent will be met if at least 50% of eligible patients provide written informed consent.
Measured: From the start of recruitment until completion of participant enrollment
Feasibility Outcome: Intervention Completion Rate
The proportion of enrolled participants who complete the 12-week multimodal lifestyle approach intervention program. Dropouts, withdrawals, and reasons for non-completion will also be recorded. The feasibility criterion for intervention completion will be met if at least 70% of enrolled participants complete the intervention program.
Measured: Baseline to 12 weeks
Feasibility Outcome: Participant Satisfaction and Acceptability
Participant satisfaction and acceptability of the multimodal lifestyle approach intervention program will be assessed using satisfaction ratings and a semi-structured interview at 12 weeks. The interview will explore useful components of the intervention, the most useful content and reasons, and suggestions for improvement. The feasibility criterion for satisfaction will be met if the median participant satisfaction rating is at least 8 out of 10.
Measured: 6 weeks and 12 weeks
Feasibility Outcome: Adverse Events
The occurrence, type, and severity of adverse events related to assessment, pain education, self-management support, or exercise therapy during the study period will be recorded. The feasibility criterion for safety will be met if no serious adverse events definitely or probably related to the intervention occur during the study period.
Measured: Screening to 12 weeks
Pain Intensity
Pain intensity will be assessed using the pain intensity items of the Brief Pain Inventory. Each item is rated on an 11-point numeric rating scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." The mean score ranges from 0 to 10, with higher scores indicating greater pain intensity. Screening pain intensity will be used to confirm eligibility, and follow-up assessments at 6 and 12 weeks will be used to explore changes over time.
Measured: Screening, 6 weeks, and 12 weeks
Secondary outcomes (23)
Pain Interference
Pain interference will be assessed using the interference items of the Brief Pain Inventory. Each item is rated on an 11-point numeric rating scale from 0 to 10, where 0 indicates "does not interfere" and 10 indicates "completely interferes." Higher scores indicate greater pain interference.
Measured: Baseline, 6 weeks, and 12 weeks
Pain-Related Disability
Pain-related disability will be assessed using the Pain Disability Index. The total score ranges from 0 to 70, with higher scores indicating greater pain-related disability.
Measured: Baseline, 6 weeks, and 12 weeks
Central Sensitization-Related Symptoms
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The total score ranges from 0 to 100, with higher scores indicating more severe central sensitization-related symptoms.
Measured: Screening, 6 weeks, and 12 weeks
Pressure Pain Threshold
Pressure pain threshold will be measured using a pressure algometer. The pressure pain threshold is defined as the minimum pressure intensity at which the participant first perceives the stimulus as painful. Higher values indicate lower mechanical pain sensitivity.
Measured: Baseline, 6 weeks, and 12 weeks
Temporal Summation
Temporal summation of pain will be assessed using repeated pinprick stimulation. The temporal summation response will be calculated as the change in pain rating from the initial stimulus to repeated stimuli. Higher values indicate greater temporal summation of pain.
Measured: Baseline, 6 weeks, and 12 weeks
Conditioned Pain Modulation
Conditioned pain modulation will be assessed using pressure stimulation as the test stimulus and a conditioning stimulus. The conditioned pain modulation response will be calculated as the change in pressure pain threshold or pain rating during the conditioning stimulus compared with the test stimulus alone. Greater pain inhibition indicates more efficient endogenous pain modulation.
Measured: Baseline, 6 weeks, and 12 weeks
Pain Catastrophizing
Pain catastrophizing will be assessed using the short form of the Pain Catastrophizing Scale. The total score ranges from 0 to 24, with higher scores indicating greater pain catastrophizing.
Measured: Baseline, 6 weeks, and 12 weeks
Kinesiophobia
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia-11. The total score ranges from 11 to 44, with higher scores indicating greater fear of movement.
Measured: Baseline, 6 weeks, and 12 weeks
Pain Self-Efficacy
Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire-4. The total score ranges from 0 to 24, with higher scores indicating greater pain self-efficacy.
Measured: Baseline, 6 weeks, and 12 weeks
Anxiety Symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-2. The total score ranges from 0 to 6, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline, 6 weeks, and 12 weeks
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-2. The total score ranges from 0 to 6, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 6 weeks, and 12 weeks
Insomnia Symptoms
Insomnia symptoms will be assessed using the Athens Insomnia Scale. The total score ranges from 0 to 24, with higher scores indicating more severe insomnia symptoms.
Measured: Baseline, 6 weeks, and 12 weeks
Body Perception
Body perception will be assessed using a region-specific Fremantle Awareness Questionnaire selected according to the participant's primary pain region: the Fremantle Back Awareness Questionnaire, Fremantle Neck Awareness Questionnaire, Fremantle Shoulder Awareness Questionnaire, or Fremantle Knee Awareness Questionnaire. Each questionnaire has a total score ranging from 0 to 36, with higher scores indicating greater disturbance in body perception for the corresponding body region.
Measured: Baseline, 6 weeks, and 12 weeks
Physical Activity
Physical activity will be assessed using the Global Physical Activity Questionnaire. Total physical activity will be expressed as metabolic equivalent task (MET)-minutes per week. Higher values indicate greater physical activity.
Measured: Baseline, 6 weeks, and 12 weeks
Activity Pacing
Activity pacing will be assessed using the pacing scale of the Patterns of Activity Measure-Pain. The pacing scale score ranges from 0 to 40, with higher scores indicating greater use of activity pacing.
Measured: Baseline, 6 weeks, and 12 weeks
Work Productivity
Work productivity will be assessed using the World Health Organization Health and Work Performance Questionnaire. Work performance will be rated on a scale from 0 to 10, with higher scores indicating better work performance.
Measured: Baseline, 6 weeks, and 12 weeks
Health-Related Quality of Life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire. The index score will be calculated using the Japanese value set. Scores range from -0.025 to 1.000, with higher scores indicating better health-related quality of life.
Measured: Baseline, 6 weeks, and 12 weeks
Goal Attainment
Individualized goal attainment will be assessed using Goal Attainment Scaling. Each goal will be rated on a 5-point scale from -2 to +2, where -2 indicates much less than the expected outcome, 0 indicates the expected outcome, and +2 indicates much more than the expected outcome. Higher scores indicate greater goal attainment.
Measured: Baseline, 6 weeks, and 12 weeks
Grip Strength
Grip strength will be assessed using a handgrip dynamometer. Grip strength will be recorded in kilograms, with higher values indicating greater muscle strength.
Measured: Baseline, 6 weeks, and 12 weeks
Two-Step Test
Physical function will be assessed using the Two-Step Test. The two-step value will be calculated by dividing the maximum length of two steps by the participant's height. Higher values indicate better physical function.
Measured: Baseline, 6 weeks, and 12 weeks
Pain Education Understanding
Understanding of pain education will be assessed using pain education understanding ratings.
Measured: Baseline, 6 weeks, and 12 weeks
Global Rating of Change
Participant-perceived overall improvement or worsening will be assessed using the Global Rating of Change Scale. Scores range from -5 to +5, where -5 indicates "very much worse," 0 indicates "no change," and +5 indicates "completely recovered." Higher scores indicate greater perceived improvement.
Measured: 6 weeks and 12 weeks
Treatment Expectancy
Patient perceptions of treatment credibility and treatment expectancy will be assessed using the Credibility/Expectancy Questionnaire. The questionnaire includes treatment credibility items and treatment expectancy items. Scores for each factor range from 3 to 27, with higher scores indicating greater treatment credibility or expectancy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, single-arm, pre-post pilot feasibility study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prefectural University of Hiroshima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomohiko Nishigami, Prefectural University of Hiroshima
- Investigators
- Tomohiko Nishigami, PhD, Principal investigator, Prefectural University of Hiroshima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693062
- Sponsor's protocol ID
- 26MH005
- Acronym
- MLA-MM
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because a data-sharing plan has not been established and data sharing would require additional ethical and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Using a Multimodal Lifestyle Approach for Patients With Chronic Pain Showing Nociplastic Pain Features: A Single-Arm Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07693062
- Acronym / sponsor ID
- MLA-MM / 26MH005
- Conditions
- Chronic Pain, Nociplastic Pain
- Keywords
- Chronic pain, Nociplastic pain, Multimodal lifestyle approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Prefectural University of HiroshimaUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, single-arm pilot feasibility study aims to examine the feasibility and preliminary effectiveness of an intervention program using a pain education booklet based on a multimodal lifestyle approach for patients with chronic pain with features of nociplastic pain. Participants will receive pain education and self-management support using a booklet developed by the investigators, together with exercise therapy provided as part of usual outpatient rehabilitation. The intervention includes pain science education, shared decision-making, goal setting, physical activity and exercise, sleep, stress management, diet, work environment, headache-related lifestyle factors, and strategies for recovery-oriented and sustainable activities. Feasibility outcomes include recruitment and consent rates, intervention completion rate, assessment completion rate, participant satisfaction, reasons for dropout, adverse events, and practical difficulties during implementation. Preliminary effectiveness will be explored using patient-reported outcomes and physical function measures at baseline, 6 weeks, and 12 weeks.
Detailed description
Chronic pain has a substantial impact on activities of daily living, quality of life, work participation, and socioeconomic burden. Chronic pain is understood within a biopsychosocial framework, and modifiable lifestyle factors such as sleep, stress, physical activity, and exercise may contribute to the persistence or exacerbation of pain. In recent years, nociplastic pain has been recognized as an important mechanism in some patients with chronic pain that cannot be fully explained by nociceptive or neuropathic pain alone. Nociplastic pain may be associated with widespread pain, hyperalgesia, sleep disturbance, fatigue, mood and cognitive symptoms, and sensory hypersensitivity. A multimodal lifestyle approach, which combines pain education with individualized support for lifestyle factors such as physical activity, exercise, sleep, and stress management, may be useful for patients with chronic pain showing nociplastic pain features. Therefore, this study will evaluate the feasibility and preliminary effectiveness of a booklet-based multimodal lifestyle intervention in an outpatient clinical setting. This initial feasibility study will focus on a general outpatient chronic pain population with suspected nociplastic pain features, while excluding specific or complex pain-related conditions that may require specialized management. As this is a single-arm pilot feasibility study delivered within usual outpatient rehabilitation, preliminary effectiveness outcomes will be interpreted exploratorily and will not be used to estimate causal effects. The findings will inform the feasibility, acceptability, and design of a future controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, single-arm, pre-post pilot feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Lifestyle Approach | Experimental | Behavioral: Multimodal Lifestyle Approach Using a Pain Education BookletParticipants in this single-arm study will receive a 12-week booklet-based multimodal lifestyle intervention, together with exercise therapy as part of usual outpatient rehabilitation. The intervention focuses on pain education, goal setting, shared decision-making, lifestyle-related self-management, recovery-oriented activities, and exercise or physical activity guidance. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Receiving rehabilitation services at the study site.
- Aged 20 to 75 years.
- Chronic pain lasting for at least 3 months.
- Pain intensity of 3 or higher on an 11-point Numerical Rating Scale.
- Suspected involvement of nociplastic pain, assessed using a screening procedure based on clinical criteria and grading for chronic nociplastic pain affecting the musculoskeletal system.
Key exclusion criteria (7 listed)
- Presence of specific pain-related conditions or symptoms, including fracture, rheumatic disease, musculoskeletal surgery within the past 3 years, fibromyalgia, or complex regional pain syndrome.
- Inability to follow the study schedule.
- Receiving compensation for absence from work due to a traffic accident or work-related injury.
- Difficulty using Japanese.
- Cognitive impairment that may affect the assessment procedures or pain education.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Lifestyle Approach Using a Pain Education BookletParticipants will receive booklet-based pain education and self-management support using a multimodal lifestyle approach, together with exercise therapy as part of usual outpatient rehabilitation. The intervention will be delivered once per week for 12 weeks, with each session lasting approximately 40 minutes. Core components include goal setting, shared decision-making, pain science education, lifestyle support, recovery-oriented activities, and exercise or physical activity guidance. The first session will include orientation to the booklet and confirmation of pain-related problems and goals. Subsequent sessions will review understanding, progress, and barriers, and adjust goals or self-management strategies as needed. The physiotherapist may tailor the emphasis, exercise content, and self-management strategies according to each participant's symptoms, goals, and response to rehabilitation. Intervention fidelity will be monitored using session records and a checklist. | Behavioural | Multimodal Lifestyle Approach |
Primary outcome
Feasibility Outcome: Consent Rate
Time frame: From the start of recruitment until completion of participant enrollment
The proportion of eligible patients who provide written informed consent to participate in the study. The feasibility criterion for consent will be met if at least 50% of eligible patients provide written informed consent.
Feasibility Outcome: Intervention Completion Rate
Time frame: Baseline to 12 weeks
The proportion of enrolled participants who complete the 12-week multimodal lifestyle approach intervention program. Dropouts, withdrawals, and reasons for non-completion will also be recorded. The feasibility criterion for intervention completion will be met if at least 70% of enrolled participants complete the intervention program.
Feasibility Outcome: Participant Satisfaction and Acceptability
Time frame: 6 weeks and 12 weeks
Participant satisfaction and acceptability of the multimodal lifestyle approach intervention program will be assessed using satisfaction ratings and a semi-structured interview at 12 weeks. The interview will explore useful components of the intervention, the most useful content and reasons, and suggestions for improvement. The feasibility criterion for satisfaction will be met if the median participant satisfaction rating is at least 8 out of 10.
Feasibility Outcome: Adverse Events
Time frame: Screening to 12 weeks
The occurrence, type, and severity of adverse events related to assessment, pain education, self-management support, or exercise therapy during the study period will be recorded. The feasibility criterion for safety will be met if no serious adverse events definitely or probably related to the intervention occur during the study period.
Pain Intensity
Time frame: Screening, 6 weeks, and 12 weeks
Pain intensity will be assessed using the pain intensity items of the Brief Pain Inventory. Each item is rated on an 11-point numeric rating scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." The mean score ranges from 0 to 10, with higher scores indicating greater pain intensity. Screening pain intensity will be used to confirm eligibility, and follow-up assessments at 6 and 12 weeks will be used to explore changes over time.
23 secondary outcomes
Pain Interference
Time frame: Baseline, 6 weeks, and 12 weeks
Pain-Related Disability
Time frame: Baseline, 6 weeks, and 12 weeks
Central Sensitization-Related Symptoms
Time frame: Screening, 6 weeks, and 12 weeks
Pressure Pain Threshold
Time frame: Baseline, 6 weeks, and 12 weeks
Temporal Summation
Time frame: Baseline, 6 weeks, and 12 weeks
Conditioned Pain Modulation
Time frame: Baseline, 6 weeks, and 12 weeks
Pain Catastrophizing
Time frame: Baseline, 6 weeks, and 12 weeks
Kinesiophobia
Time frame: Baseline, 6 weeks, and 12 weeks
Pain Self-Efficacy
Time frame: Baseline, 6 weeks, and 12 weeks
Anxiety Symptoms
Time frame: Baseline, 6 weeks, and 12 weeks
Depressive Symptoms
Time frame: Baseline, 6 weeks, and 12 weeks
Insomnia Symptoms
Time frame: Baseline, 6 weeks, and 12 weeks
Body Perception
Time frame: Baseline, 6 weeks, and 12 weeks
Physical Activity
Time frame: Baseline, 6 weeks, and 12 weeks
Activity Pacing
Time frame: Baseline, 6 weeks, and 12 weeks
Work Productivity
Time frame: Baseline, 6 weeks, and 12 weeks
Health-Related Quality of Life
Time frame: Baseline, 6 weeks, and 12 weeks
Goal Attainment
Time frame: Baseline, 6 weeks, and 12 weeks
Grip Strength
Time frame: Baseline, 6 weeks, and 12 weeks
Two-Step Test
Time frame: Baseline, 6 weeks, and 12 weeks
Pain Education Understanding
Time frame: Baseline, 6 weeks, and 12 weeks
Global Rating of Change
Time frame: 6 weeks and 12 weeks
Treatment Expectancy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because a data-sharing plan has not been established and data sharing would require additional ethical and institutional approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomohiko Nishigami, PhD principal investigator
Prefectural University of Hiroshima
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Lifestyle Approach Using a Pain Education Booklet in people with Chronic Pain and Nociplastic Pain, run by Prefectural University of Hiroshima at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomohiko Nishigami, PhD (+81 848-60-1120, tomon@pu-hiroshima.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcome: Consent Rate (time frame: From the start of recruitment until completion of participant enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.