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

Sponsor

Institut des Hautes Etudes Osteopathiques de Nantes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05785650

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Diagnostic Test: osteopathic palpation

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

61 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

sensitivity and specificity of osteopathic tests [at day 1]
to compare osteopath TP detection to ultrasound echogenicity

Secondary Outcome Measures

Inter examiner reproductibility of TP detection [at day 1]
using Cohen's kappa weighted by the distance between the TPs found. Quadratic weighting will be used.
camparison of pain reported by patient with TP detection by osteopath [at day 1]
using a student test between pain means in areas with and without TP

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institut des Hautes Etudes Osteopathiques de Nantes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SALMON Maxime, methodologist and statistician, Institut des Hautes Etudes Osteopathiques de Nantes

ClinicalTrials.gov Identifier:

NCT05785650

Other Study ID Numbers:

TRIGGOSTEO-1
2023-A00637-38

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by SALMON Maxime, methodologist and statistician, Institut des Hautes Etudes Osteopathiques de Nantes

trigger point

osteopathic palpation

ultrasound

Additional relevant MeSH terms:

Shoulder Pain

Study Results

No Results Posted as of Mar 28, 2023