Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation

Shoulder Pain Clinical Trial

Official title:

Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05785650
• Other study ID #: TRIGGOSTEO-1
• Secondary ID: 2023-A00637-38
• Status: Not yet recruiting
• Start date: August 30, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: Institut des Hautes Etudes Osteopathiques de Nantes
• Contact: Maxime Salmon
• Phone: +332 28 07 29 28
• Email: msalmon[@]idheo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 61
• Est. completion date: May 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Diagnostic Test:
• osteopathic palpation
comparaison of ultrasound caracteristics of areas with ad without TP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut des Hautes Etudes Osteopathiques de Nantes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of osteopathic tests	to compare osteopath TP detection to ultrasound echogenicity	at day 1
Secondary	Inter examiner reproductibility of TP detection	using Cohen's kappa weighted by the distance between the TPs found. Quadratic weighting will be used.	at day 1
Secondary	camparison of pain reported by patient with TP detection by osteopath	using a student test between pain means in areas with and without TP	at day 1