UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059476 |
|---|---|
| Receipt number | R000067987 |
| Scientific Title | Evaluation of the usefulness of extracorporeal shock wave therapy(ESWT) for chronic secondary musculoskeletal pain in patients attending a palliative care outpatient clinic |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/10/20 20:02:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to evaluate the effect of extracorporeal shock wave therapy for chronic body pain in patients attending a palliative care outpatient clinic
Acronym
Extracorporeal shock wave therapy palliative care study
Scientific Title
Evaluation of the usefulness of extracorporeal shock wave therapy(ESWT) for chronic secondary musculoskeletal pain in patients attending a palliative care outpatient clinic
Scientific Title:Acronym
ESWT-Palliative study
Region
| Japan |
Condition
Condition
Chronic secondary musculoskeletal pain
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the usefulness of extracorporeal shock wave therapy (ESWT) as a supportive care intervention for alleviating pain and improving activities of daily living (ADL) in patients attending a palliative care outpatient clinic.
The study targets patients diagnosed with chronic secondary musculoskeletal pain based on the chronic pain classification established by the International Association for the Study of Pain (IASP) and defined in the International Classification of Diseases, 11th Revision (ICD-11).ESWT will be administered to these patients, and its analgesic effects and improvements in daily functioning will be evaluated to explore its potential role in relieving the distress of patients receiving palliative care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in pain intensity assessed by the Numerical Rating Scale (NRS) before and after ESWT.
Key secondary outcomes
Change in range of motion (ROM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
After diagnosis of chronic secondary musculoskeletal pain by the attending physician, written informed consent will be obtained by the investigator. The investigator will then determine the treatment site and set the parameters for extracorporeal shock wave therapy (ESWT).
Before treatment, the following will be assessed: Numerical Rating Scale (NRS) for pain, Activities of Daily Living (ADL), Range of Motion (ROM) related to the selected treatment site.
Extracorporeal Shock Wave Therapy (ESWT) will be performed while confirming the presence or absence of pain during treatment. Example settings are as follows: Trapezius muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-2.0 bar. Quadratus lumborum muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-3.0 bar. Gluteus maximus muscle: Transmitter R10-12, 2000 shocks per site, energy level 1.0-3.0 bar.
After treatment, the following will be re-evaluated: NRS, ADL, and ROM related to the treated site. Presence of any adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE).
Follow-up: The next outpatient visit will be scheduled, and at the subsequent visit, the patient will be asked about the perceived onset and duration of pain relief following ESWT.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age, sex, and underlying disease are not limited.
Patients diagnosed with chronic secondary musculoskeletal pain during outpatient visits.
Patients who have provided consent to receive extracorporeal shock wave therapy (ESWT).
Patients who have provided consent to participate in the study.
In cases where the patient is unable to sign due to any reason, verbal consent or proxy consent will be accepted.
Key exclusion criteria
Patients whom the investigator judges to be inappropriate for inclusion in the study.
Patients with any lesion (e.g., malignant tumor, metastasis, or fracture) within 5 cm of the planned ESWT treatment site.
Patients who develop skin disorders of CTCAE Grade 2 after ESWT.
Patients who refuse ESWT after enrollment.
Patients with severe cognitive impairment or psychiatric disorders that make appropriate evaluation difficult.
Patients with a high risk of bleeding, such as those with coagulation disorders or taking anticoagulant medications.
Patients with cardiovascular devices (e.g., pacemaker) located at or near the planned treatment site.
Patients with local infection or purulent lesions at the planned treatment site.
Patients who are pregnant or may be pregnant.
Patients with severe osteoporosis who have an extremely high risk of fracture.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | suga |
| Middle name | |
| Last name | kentaro |
Organization
Saitama Medical University Hospital
Division name
palliative care team
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761111
suga.kentaro@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | suga |
| Middle name | |
| Last name | kentaro |
Organization
Saitama Medical University Hospital
Division name
palliative care team
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761111
Homepage URL
suga.kentaro@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
0492761111
suga.kentaro@1972.saitama-med.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
| 2025 | Year | 12 | Month | 25 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067987
