UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062046 |
|---|---|
| Receipt number | R000070994 |
| Scientific Title | Effects of Different Trigger Point Acupuncture Retention Times on Pressure Pain Thresholds in Patients with Chronic Low Back Pain: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/24 17:15:59 |
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Basic information
Public title
Effects of Different Acupuncture Retention Times at Trigger Points on Pain Sensitivity in Individuals with Chronic Low Back Pain
Acronym
Time dependent Effects of Acupuncture in Chronic Low Back Pain
Scientific Title
Effects of Different Trigger Point Acupuncture Retention Times on Pressure Pain Thresholds in Patients with Chronic Low Back Pain: A Randomized Controlled Trial
Scientific Title:Acronym
TrP TIME Trial
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 effects of different acupuncture stimulation durations on peripheral sensitization in patients with chronic low back pain. Acupuncture will be applied under ultrasound guidance to tissues associated with symptom reproduction identified at sites where pressure provokes the patient's typical low back pain. Pressure pain threshold will be assessed as an indicator of peripheral sensitization, and changes will be compared among different stimulation-duration conditions.
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
Key secondary outcomes
Subjective pain intensity assessed using the Numeric Rating Scale (NRS)
Assessment time points:Baseline, immediately after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and removed immediately after insertion.
Interventions/Control_2
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 1 minute.
Interventions/Control_3
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 5 minutes.
Interventions/Control_4
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 10 minutes.
Interventions/Control_5
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 20 minutes.
Interventions/Control_6
A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 30 minutes.
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
60
Research contact person
Name of lead principal investigator
| 1st name | yoji |
| Middle name | |
| Last name | kitagawa |
Organization
Kansai University of Health Sciences
Division name
Faculty of Health Sciences
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka 590-0482, Japan
TEL
0724538251
kitagawa@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
Faculty of Health Sciences
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 | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 24 | 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 | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070994
