Clinical trial NCT05785650: Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
Official title: Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Pain
Keywords: trigger point
osteopathic palpation
ultrasound
Lead sponsor: Institut des Hautes Etudes Osteopathiques de Nantes
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 61 healthy adults The population studied will be heterogeneous with or without shoulder pain Recruitment will be based on students or patients of IdHEO Nantes osteopathy clinic on a voluntary basis.

Brief summary: Trigger points (TP) are described as "hard, palpable nodules located within the taut bands of skeletal muscle" (Bardoni, 2022).

The aim of this study is to evaluate the reproductibility of palpation of TP between osteopaths and to compare this perception to ultrasound measures of echogenicity.

Method:

A sample of 61 patients will be included in the study. An osteopath will determine the eligibility of the study. The supraclavicular area will be mark every 2 cm to establish a grid for all evaluations.

First an osteopath will evaluate with palpation the presence of TP at every box of the grid.

A second osteopath will evaluate the same boxes and will be blinded to the result of the first osteopath.

At each step of palpation, a pain assessment will be carried out at each box. Then, the ultrasound technician will evaluate the echogeneicity of every box and will be blinded to the prior results.

The protocol will be approve by a french ethic committee.

Detailed description: sensitivity and specificity of osteopathic tests will be conducted in comparaison to echograph results (a binary outcomes assessing the presence of an hypoechogenicity).

The reproductibility of osteopaths' tests will be be calculated using Cohen's kappa weighted by the distance between the TPs found.

Finally, the pain reported by patients on areas with a TP defined by the osteopath, and the pain reported by patients on areas without a TP defined by the osteopath will be compared using a student test.

Eligibility criteria: Inclusion Criteria:

* Adults (18 to 50 years old),
* affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* pregnant and breastfeeding women,
* adults under guardianship and protected patients.
* History of integumentary or muscular involvement in the area of interest
* Allergic reaction
* wish to stop the study

Primary outcomes:
measure: sensitivity and specificity of osteopathic tests
timeFrame: at day 1
Secondary outcomes:
measure: Inter examiner reproductibility of TP detection
timeFrame: at day 1
measure: camparison of pain reported by patient with TP detection by osteopath
timeFrame: at day 1
Other outcomes:
Locations:
Study officials:
References: