UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061637 |
|---|---|
| Receipt number | R000070520 |
| Scientific Title | The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/19 22:55:12 |
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Basic information
Public title
The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial
Acronym
The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial
Scientific Title
The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial
Scientific Title:Acronym
The effect of press needles on myofascial pain syndrome in patients with advanced cancer: a randomized controlled trial
Region
| Japan |
Condition
Condition
myofascial pain syndrome
Classification by specialty
| Hematology and clinical oncology | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the analgesic effect of press needles on myofascial pain syndrome, which occurs in terminally ill cancer patients who are bedridden for long periods of time, and to establish a non-pharmacological analgesic treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in pain change 24 hours before and after placement of press needles (Numerical Rating Scale)
Key secondary outcomes
1) Secondary effects other than pain relief (improvement of sleep, fatigue, etc.)
2) Frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Press needle placement is performed on patients with advanced cancer who are hospitalized in a palliative care ward and have myofascial pain syndrome. Before inserting the Press needles, the painful areas that meet the diagnostic criteria for MPS are identified by palpation based on Rivers' diagnostic criteria. After identifying the pain site, the physician places 1.5 mm press needles (Pyonex, Seirin TM) in patients in the acupuncture group. Pain assessment and treatment are performed by different physicians. The treatment is performed in a way that the shape of the needles is not visible to the patients, and they are not informed which type of needle was placed (the practitioners are not blinded because the needles have different shapes).
Interventions/Control_2
Press needle placement is performed on patients with advanced cancer who are hospitalized in a palliative care ward and have myofascial pain syndrome. Before inserting the Press needles, the painful areas that meet the diagnostic criteria for MPS are identified by palpation based on Rivers' diagnostic criteria. After identifying the pain site, the physician places sham needles (brand names: Pyonex Zero, Seirin TM) in patients in the acupuncture-free group. Pain assessment and treatment are performed by different physicians. The treatment is performed in a way that the shape of the needles is not visible to the patients, and they are not informed which type of needle was placed (the practitioners are not blinded because the needles have different shapes).
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 2-4
2)Those diagnosed with MPS who meet Rivers' diagnostic criteria
3)Those with pain in the area affected by MPS of NRS 4/10
4)Those whose MPS is caused by being bedridden for more than one week
Key exclusion criteria
1)Those who are likely to bleed easily
2)Those who are likely to be susceptible to infection
3)Those who have skin abnormalities such as redness, swelling, or edema at the site of pain that may be MPS
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
NHO Hokkaido Cancer Center
Division name
Division of Palliative Care Medicine
Zip code
0030804
Address
2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
09036406610
cab55640@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
NHO Hokkaido Cancer Center
Division name
Division of Palliative Care Medicine
Zip code
3900803
Address
2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
09036406610
Homepage URL
cab55640@yahoo.co.jp
Sponsor or person
Institute
NHO Hokkaido Cancer Center
Institute
Department
Personal name
Kenji Yamamoto
Funding Source
Organization
none
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
NHO Hokkaido Cancer Center IRB
Address
2-3-54 Kikusui 4-jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
Tel
011-811-9111
100-mb10kar5@mail.hosp.go.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 | 07 | Month | 01 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070520
