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METHODS AND ASSESSMENT

Technique and measurement

Recording force, contact, movement and measurement separately is where reproducible research starts.

How to read our protocols
Unit of force
Newton (N)
Local measures
Muscle hardness · SWE · tissue thickness
Clinical measures
Pain · function · range of motion

Intervention conditions by study

Practical session: contact on the lower back combined with a small movement of the trunk
Contact and movement being checked in a practical session. The table below gives the force, contact and movement used in each study. Photo: Japan Health Organization
StudyIntervention and controlTime points
Load, contact size and muscle hardness Seated, side-bending. No load / 2.5 / 4.9 / 7.4 / 9.8 N (250–1,000 g in the paper); tip diameter 1 / 2 / 3 cm.Before and after
Layer-specific SWE 4.9 N versus 0.49 N. Ten minutes, movement and duration matched. Crossover with a 7-day interval. (Manuscript submitted.)SWE: before, immediately after, 15 min
Chronic whiplash-associated disorder Single session to the neck and shoulder girdle at about 4.9 N, up to 20 minutes, ending earlier if pain resolved.Before, immediately after, 7 days, 28 days, 3 and 6 months

Procedures are set to suit the participants and the aim of each study. Stating the load and the measurement together lets findings be carried into the next comparison.

Force: nominal values and notation

In general descriptions we use approximately 5.0 N. We report the applied force and contact diameter separately, so that both the magnitude and distribution of loading can be understood. Study-specific values, including 4.9 N, 7.4 N and 0.49 N, retain the precision used in their sources.

In the whiplash study, variation in applied force was checked with a digital force gauge before the session. The loads reported are therefore target values based on calibration beforehand. Continuous force recording during the session would raise reproducibility further and is a topic we would like to develop with partners.

Load gauge and interchangeable contact tips of different diameters
Load gauge and contact tips. Force and tip diameter are recorded separately. Photo: Japan Health Organization

What each measurement tells us

MeasurementWhat it showsConditions that make it interpretable
SWE: shear wave speed (m/s)Change in the mechanical state of a defined regionHarmonise posture, breathing, probe pressure, depth and tissue orientation; combine with structural imaging.
Muscle hardness meterChange in resistance to indentation at the measurement siteSame device, posture and contact conditions, so that studies can be compared and repeatability assessed.
B-mode tissue thicknessThickness of a layer defined on the imageDescribes shape; combined with SWE and muscle activity to study how relaxation comes about.
VAS, NDI, ROMPain, disability and range of motionSeparate self-report from assessor measurement; give the change, the denominator and the follow-up period.

Muscle hardness meter

The 2025 dose-parameter study and the 2012 low-back-pain study measured resistance to indentation with a hand-held hardness meter (the 2012 study used a PEK-1). Readings are on a device-specific scale. We therefore state the principle and unit of each instrument — hardness meter, SWE shear wave speed, muscle activity — so that tissue softness can be understood from several angles.

Layers assessed with SWE

In the abdominal-wall study, shear wave elastography assessed four layers — subcutaneous fat, the superficial fascial interface, the external oblique, and the deep myofascial interface between the external and internal oblique — before, immediately after and 15 minutes after each procedure.

The manuscript has been submitted. Device, probe, measurement points, acquisition settings and analysis will be added here on publication.

Ultrasound elastography screen showing a B-mode image beside a colour map, with circular regions of interest and shear wave speed values
Example of an SWE measurement screen: B-mode image on the left, colour map on the right, with regions of interest and their values. Photo: Takashi SakatoOpen full size

Study summary

Items to harmonise in a replication

Research direction

  • Eligibility criteria, concurrent treatment, meals, exercise and time of day.
  • Treated site, posture, force, contact diameter, movement, duration and practitioner experience.
  • Control condition, allocation of order, assessor blinding, interval and carry-over.
  • Instruments, acquisition settings, number of repeats, primary outcome and analysis plan.
  • Safety records covering comfort, changes in condition, continuation in the study, and symptoms that appear later.

Discuss a replication or a joint study

Sources

  1. Sugimoto S, Sakato T, Nakayama T, et al. Effect of Kanshoho on lumbar muscle tone [in Japanese]. Journal of Physical Therapy Fundamentals. 2025;28(1):32–38. doi:10.24780/jjptf.JJPTF_2023-17
  2. Sakaguchi H, Sakato T, Yamamoto K, et al. The effect of Kanshoho on low back pain (lumbago) [in Japanese]. Japanese Journal of Integrative Medicine. 2012;5(1):62–67 (PDF)
  3. Study A (submitted manuscript): shear wave elastography of the lateral abdominal wall in 20 healthy men, randomised crossover pilot study. Trial registration UMIN000056162. This site reports only what is public in the registry and in our symposium abstract for the 28th World Congress of the International College of Psychosomatic Medicine (ICPM 2026, Fukuoka). Full details will be added when the paper is published.
  4. 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).

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

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