Trigger Points of Supraspinatus Muscle: Osteopaths' Palpa... | NCT05785650

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

NCT05785650

Sponsor

Institut des Hautes Etudes Osteopathiques de Nantes

Status

Unknown status

Last Update Posted

Jul 20, 2023Actual

Enrollment

61Estimated

Phase

Not provided

Conditions

Shoulder Pain

Interventions

osteopathic palpation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A00637-38	Other Identifier	Agence nationale de sécurité du médicament et produits de santé

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2023Estimated

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

Mar 14, 2023

First Posted Date

Mar 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
osteopathic palpation	Diagnostic Test	comparaison of ultrasound caracteristics of areas with ad without TP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity and specificity of osteopathic tests	to compare osteopath TP detection to ultrasound echogenicity	at day 1

Secondary Outcomes

Measure	Description	Time Frame
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
camparison of pain reported by patient with TP detection by osteopath

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maxime Salmon	Contact	+332 28 07 29 28		msalmon@idheo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

on demand to m. salmon

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020069	Shoulder Pain

Ancestor Terms

ID	Term
D018771	Arthralgia
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided