UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060638 |
|---|---|
| Receipt number | R000069353 |
| Scientific Title | An Investigation of Factors Associated with the Effects of Acupuncture for Low Back Pain and Shoulder Stiffness |
| Date of disclosure of the study information | 2026/02/11 |
| Last modified on | 2026/02/10 10:38:08 |
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Basic information
Public title
An Investigation of Factors Associated with the Effects of Acupuncture for Low Back Pain and Shoulder Stiffness
Acronym
An Investigation of Factors Associated with the Effects of Acupuncture
Scientific Title
An Investigation of Factors Associated with the Effects of Acupuncture for Low Back Pain and Shoulder Stiffness
Scientific Title:Acronym
An Investigation of Factors Associated with the Effects of Acupuncture for Low Back Pain and Shoulder Stiffness
Region
| Japan |
Condition
Condition
Low Back Pain, Shoulder Stiffness
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An Investigation of Factors Associated with the Effects of Acupuncture for Low Back Pain and Shoulder Stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PDAS, NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
acupuncture
Interventions/Control_2
No treatment
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients have low back pain that has lasted for more than three months, and the intensity and frequency of the pain does not interfere with daily activities or the continuation of normal work.
2) Patients with shoulder stiffness, regardless of duration, presenting with discomfort or pain of mild to moderate intensity that allows activities of daily living and continuation of regular work.
Key exclusion criteria
1) Presence of acute inflammatory conditions.
2) For low back pain: Patients with specific underlying diseases for which standard treatment is the first-line therapy, serious organic diseases, or severe neurological symptoms (e.g., bladder and bowel dysfunction,intermittent claudication), and those judged unsuitable for acupuncture treatment. Patients receiving acupuncture for pain control after conservative or surgical treatment are not excluded.
3) For shoulder stiffness: Patients with specific underlying diseases with established standard treatments, serious organic diseases, or severe neurological symptoms, and those judged
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Takaoka |
Organization
Toyama University
Division name
Academic Research Department, Medical Sciences
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture, 930-0194
TEL
0764347317
ytakaoka@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Someya |
Organization
Toyama University
Division name
Academic Research Department, Medical Sciences
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
0764347317
Homepage URL
ysomeya@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Yoshiaki Someya
Funding Source
Organization
Toyama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Toyama
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Clinical and Epidemiological Research
Address
2630 Sugitani, Toyama City, Toyama Prefecture, 930-0194
Tel
0764346011
info@u-toyama.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 | 02 | Month | 11 | 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 | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069353
