UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062615 |
|---|---|
| Receipt number | R000071659 |
| Scientific Title | Effectiveness of radial extracorporeal shockwave therapy (rESWT) for post-stroke shoulder pain: a randomized controlled trial |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 10:06:39 |
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Basic information
Public title
Effectiveness of radial extracorporeal shockwave therapy (rESWT) for shoulder pain in patients with stroke
Acronym
Radial extracorporeal shockwave therapy (rESWT) for post-stroke shoulder pain
Scientific Title
Effectiveness of radial extracorporeal shockwave therapy (rESWT) for post-stroke shoulder pain: a randomized controlled trial
Scientific Title:Acronym
Radial extracorporeal shockwave therapy (rESWT) for post-stroke shoulder pain: a randomized controlled trial
Region
| Japan |
Condition
Condition
Post-stroke shoulder pain
Classification by specialty
| Neurology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of radial extracorporeal shockwave therapy (rESWT) for shoulder pain in patients with stroke.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Worst shoulder pain during the past 24 hours (Brief Pain Inventory [BPI], Question 3: Worst pain)
Key secondary outcomes
1.Pain intensity: Mean score of the four pain intensity items of the Brief Pain Inventory (BPI)
2.Pain interference: Mean score of the seven pain interference items of the Brief Pain Inventory (BPI)
3.Pain during passive movement: Numeric Rating Scale (NRS) during passive range-of-motion (ROM) assessment
4.Passive range of motion: Passive range of motion (ROM) of the shoulder joint
5.Global perceived improvement: Global Rating of Change (GROC) scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Radial extracorporeal shockwave therapy (rESWT) will be applied to the affected shoulder for 2 weeks, twice weekly, for a total of 4 sessions. Each session will consist of 6,000 shocks at a pressure of 2 bar and a frequency of 15 Hz. After the initial 2-week intervention period, no further rESWT will be administered, and the participants will be followed during the subsequent observation period.
Interventions/Control_2
Sham radial extracorporeal shockwave therapy (sham rESWT) will be applied to the affected shoulder for 2 weeks, twice weekly, for a total of 4 sessions. The sham treatment will follow the same treatment procedures and treatment duration as the rESWT group but will use a sham stimulus that does not deliver therapeutic shockwave energy. After the initial 2-week sham intervention period, participants will receive open-label rESWT during the subsequent intervention period.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals with hemiparesis resulting from stroke (cerebral infarction or intracerebral hemorrhage)
2. Individuals with pain localized to the affected shoulder joint
Key exclusion criteria
1. Individuals who have difficulty understanding the study procedures due to higher brain dysfunction (attention, memory, apraxia, aphasia, or unilateral spatial neglect) or cognitive impairment
2. Individuals whose dosage of analgesic medication may be changed during the study period
3. Individuals who are receiving intra-articular injections or are likely to receive such injections during the study period
4. Individuals receiving anticoagulant therapy with an international normalized ratio (INR) >4.0
5. Individuals with shoulder pain that was present before the onset of stroke
6. Individuals who meet the diagnostic criteria for complex regional pain syndrome (CRPS)
7. Individuals with allodynia
8. Individuals with causes of shoulder pain other than hemiplegic shoulder pain (HSP)
9. Individuals whom the attending physician considers unsuitable for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyai |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
536-0025
Address
2-1-88 Morinomiya, Joto-ku, Osaka, Japan.
TEL
06-6969-8170
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Officer
Zip code
5360025
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL
06-6969-0111
Homepage URL
miyata@omichikai.or.jp
Sponsor or person
Institute
Morinomiya hospital
Institute
Department
Personal name
Miyai Ichiro
Funding Source
Organization
Morinomiya Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Omichi-kai Social Medical Corporation IRB
Address
2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel
06-6969-0111
nrri-jimu@omichikai.or.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
森之宮病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 21 | 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
| 2026 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
| 2029 | Year | 08 | Month | 24 | Day |
Date trial data considered complete
| 2029 | Year | 08 | Month | 24 | Day |
Date analysis concluded
| 2029 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071659
