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

NCT05785650 | Unknown DMC

• 2 other identifiers: TRIGGOSTEO-12023-A00637-38
• Study Type: observational
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain

Keywords

trigger point; osteopathic palpation; ultrasound

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity of osteopathic tests

  to compare osteopath TP detection to ultrasound echogenicity

  at day 1

Secondary Outcomes (2)

• Inter examiner reproductibility of TP detection

  at day 1

• camparison of pain reported by patient with TP detection by osteopath

  at day 1

Interventions

osteopathic palpation DIAGNOSTIC_TEST

comparaison of ultrasound caracteristics of areas with ad without TP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut des Hautes Etudes Osteopathiques de Nantes: lead

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maxime Salmon

CONTACT

+332 28 07 29 28; msalmon@idheo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: August 30, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE