UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058323 |
|---|---|
| Receipt number | R000066467 |
| Scientific Title | Interventional Effects of Kanshoho on Patients with Sequelae of Cervical Sprain |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/30 19:33:27 |
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Basic information
Public title
Interventional Effects of Kanshoho on Patients with Sequelae of Cervical Sprain
Acronym
Interventional Effects of Kanshoho on Patients with Sequelae of Cervical Sprain
Scientific Title
Interventional Effects of Kanshoho on Patients with Sequelae of Cervical Sprain
Scientific Title:Acronym
Interventional Effects of Kanshoho on Patients with Sequelae of Cervical Sprain
Region
| Japan |
Condition
Condition
Chronic whiplash-associated disorder (WAD)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will target patients with sequelae of cervical sprain (chronic whiplash injury), and will involve administering the manual therapy "Kansyoho" to soft tissues such as muscles and tendons, and verifying the clinical effectiveness before and after treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immediate effect of a single Kanshoho session performed on the study day.
Assessment time-points: immediately before the intervention (0 min) and immediately after completion (within 20 min).
Assessment variable: pain intensity measured with a 0-100 mm Visual Analog Scale (VAS).
Primary outcome: change in VAS score (post minus pre).
Key secondary outcomes
1. Change in cervical range of motion
Variable: sum of flexion, extension, right/left rotation, and right/left lateral flexion angles
Assessment time-points: immediately before the intervention (0 min) and immediately after completion (within 20 min); outcome = post minus pre difference
2. Ultrasonographic changes of soft tissue
Variable: immediate changes in echogenicity and morphology at the painful site on B-mode ultrasound
Assessment time-points: immediately before and immediately after the intervention using the same probe position
3. Procedure time
Variable: total duration (minutes) from the start of Kanshoho to pain disappearance or 20 minutes, whichever occurs first
Assessment time-points: recorded once on the intervention day
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Content: One session of Kanshoho
Pressure: ~500 g perpendicular digital pressure to target muscles
Duration: single day, up to 20 min; end earlier if pain disappears
Frequency: single session only
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic whiplash-associated symptoms for 6 months or longer without structural lesions
2. Currently visiting Shin Orthopedic Rehabilitation and Sports Clinic
3. Written informed consent obtained and approval by the attending physician
Key exclusion criteria
1. Ongoing treatment for serious comorbidities
2. Judged unsuitable by the attending physician because of excessive burden
3. Deemed ineligible by the principal investigator
4. Employees of study-related facilities and their family members
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Amitani |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Psychosomatic Internal Medicine
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
0992755751
amitani@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sakato |
Organization
Japan Health Organization (Non-profit)
Division name
Administrative Department of Clinical Trials
Zip code
103-0027
Address
1-14-5 Nihonbashi, Chuo-ku, Tokyo
TEL
0362310860
Homepage URL
sakatobni@gmail.com
Sponsor or person
Institute
Department of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Health Organization (Non-profit)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shin Orthopedic Rehabilitation and Sports Clinic (Private clinic)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
Tel
099-275-5111
crmc@m2.kufm.kagoshima-u.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
| 2025 | 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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066467
