UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062043 |
|---|---|
| Receipt number | R000070991 |
| Scientific Title | Effects of a Single Trigger Point Acupuncture Intervention on Sustained Changes in Pressure Pain Threshold in Individuals with Chronic Low Back Pain: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/26 08:33:45 |
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Basic information
Public title
Study on Changes in Pain and Duration of Effects Following Acupuncture for Chronic Low Back Pain
Acronym
Acupuncture Persistence Study for Chronic Low Back Pain
Scientific Title
Effects of a Single Trigger Point Acupuncture Intervention on Sustained Changes in Pressure Pain Threshold in Individuals with Chronic Low Back Pain: A Randomized Crossover Trial
Scientific Title:Acronym
Long-Term Effects of a Single Session of Trp Acupuncture Stimulation in Patients with Chronic Low Back Pain
Region
| Japan |
Condition
Condition
Chronic Low Back Pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the longitudinal effects of different trigger point acupuncture stimulation conditions on pressure pain threshold and subjective pain intensity in individuals with chronic low back pain, and to identify stimulation conditions associated with sustained analgesic effects following a single acupuncture intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Pressure Pain Threshold (PPT)
Assessment time points:Baseline, immediately after intervention, 1 day, 3 days, and 1 week after intervention
Key secondary outcomes
Subjective pain intensity assessed using the Numeric Rating Scale (NRS)
Tissue stiffness
Assessment time points:Baseline, immediately after intervention, 1 day, 3 days, and 1 week after intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention 1: Single-needle trigger point acupuncture in the lumbar multifidus muscle with 10-minute needle retention.
Interventions/Control_2
Intervention 2: Multiple-needle trigger point acupuncture within the trigger point region of the lumbar multifidus muscle with 10-minute needle retention.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18~65 years.
Students or employees of the university.
Individuals with chronic low back pain lasting for at least 3 months.
No history of lumbar spine surgery.
No symptoms suggestive of lower extremity radiculopathy.
Reproduction of their usual low back pain upon manual compression of the lumbar multifidus muscle, including the area approximately 2 cm lateral to the midline at the L4 vertebral level.
Ability to reliably report symptom reproduction during acupuncture stimulation.
Previous experience with acupuncture treatment.
Provision of written informed consent.
Key exclusion criteria
Individuals with severe fear of acupuncture treatment.
Individuals who have previously experienced all acupuncture stimulation as strongly unpleasant or painful sensations.
Pregnant women or individuals who may be pregnant.
Individuals with bleeding disorders or those receiving anticoagulant therapy.
Individuals with severe orthopedic, neurological, or psychiatric disorders.
Individuals deemed unsuitable for study participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kenichi |
| Middle name | |
| Last name | kimura |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka 590-0482, Japan
TEL
0724538251
k.kimura@kansai.ac.jp
Public contact
Name of contact person
| 1st name | yoji |
| Middle name | |
| Last name | kitagawa |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka 590-0482, Japan
TEL
0724538251
Homepage URL
kitagawa@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
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
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka 590-0482, Japan
Tel
0724538251
kitagawa@kansai.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 | 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 | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070991
