Participants and methods
Single-clinic, prospective, single-arm pilot study. Ten adults (5 men, 5 women) received one Kanshoho session to the neck and shoulder girdle at about 4.9 N, delivered by the developer. The session lasted up to 20 minutes and ended earlier if pain resolved.
Outcomes were pain at rest, pain at the peak pain angle (PPA-VAS), the Neck Disability Index (NDI), range of motion up to the peak pain angle (PPA-ROM, summed over three axes) and total active cervical range of motion (TCROM), measured immediately after the session and at 7 days, 28 days, 3 months and 6 months.
Change from baseline
| Outcome | Immediately after (n=10) | 6 months (n=9) |
|---|---|---|
| PPA-VAS | −33.0 mm | −33.0 mm |
| NDI | −4.0 points | −10.0 points |
| PPA-ROM | +29.3° | +22.5° |
| TCROM | +37.3° | +14.5° |
Values are medians of each participant’s change from baseline. PPA-VAS, NDI and PPA-ROM remained significantly different from baseline at 6 months after correction for multiple comparisons; for TCROM the corrected difference was significant immediately after the session.
Ten patients were assessed immediately after the session and nine thereafter; one patient took part up to the immediate assessment for personal reasons. The denominator is shown at every time point.
Exploratory ultrasound
Thickness of the deep muscle layer changed by a median of about +0.46 mm (n=8; P=0.078). Tissue thickness describes shape, whereas SWE in the abdominal-wall study describes mechanical state; the two are reported as separate measurements.
Scope and future directions
Research direction
The pilot included 10 treated patients, with 9 followed for 6 months. It supports designing a controlled comparison of pain, function and range of motion, with concurrent care, assessment conditions and expectations documented.
A multicentre study is in planning, and we invite clinical centres to discuss participation. Our February 2026 conference presentation outlined a study of additional sessions for patients with residual pain and the durability of the subsequent response. Participating sites will help define the comparator, session schedule, outcome criteria and follow-up. Read the conference plan, slide 13 (PDF)
Safety, ethics and registration
Treatment-related adverse events reported during the 6-month observation: 0.
Ethics approval: Kagoshima University Sakuragaoka Campus Clinical Research Ethics Committee (No. 240317, approved 18 April 2025). Registration: jRCT1070250094. Written informed consent was obtained. The study was supported by the Japan Health Organization and the participating clinic; the developer’s competing interests are disclosed in the manuscript.
Sources
- Manuscript B (presented at conferences; unpublished manuscript): Sakato T, Shin Y, Itai Y, Amitani H. Immediate and mid-term effects of Kanshoho in patients with chronic whiplash-associated disorders: a prospective single-arm pilot study. Presented at the 55th Annual Meeting of the Japanese Society for the Study of Chronic Pain and the 35th Annual Meeting of the Japanese Society of Pathophysiology (both 2026).
- Slides: immediate effect and 4-week outcome. 55th Annual Meeting of the Japanese Society for the Study of Chronic Pain, 27 February 2026 (PDF, Japanese)
- Slides: durability of the effect. 35th Annual Meeting of the Japanese Society of Pathophysiology, 2026 (PDF, Japanese)
Sections marked “Research direction” describe hypotheses and proposed studies for discussion with collaborators. Observations are presented with their participants, methods and sources.
Last updated: 21 September 2026