Shoulder PainNCT05785650
Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
An observational study of Shoulder Pain, run by Institut des Hautes Etudes Osteopathiques de Nantes.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- osteopathic palpation
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- Adults (18 to 50 years old),
- affiliation to a social security scheme or beneficiary of such a scheme
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- osteopathic palpation
- Keywords
- trigger point, osteopathic palpation, ultrasound
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic palpationDiagnostic test
comparaison of ultrasound caracteristics of areas with ad without TP
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of osteopathic tests
to compare osteopath TP detection to ultrasound echogenicity
Measured: at day 1
Secondary outcomes (2)
Inter examiner reproductibility of TP detection
using Cohen's kappa weighted by the distance between the TPs found. Quadratic weighting will be used.
Measured: at day 1
camparison of pain reported by patient with TP detection by osteopath
using a student test between pain means in areas with and without TP
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start30 Aug 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de Nantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785650
- Sponsor's protocol ID
- TRIGGOSTEO-1
- Other IDs
- 2023-A00637-38
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on demand to m. salmon
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
- ClinicalTrials.gov ID
- NCT05785650
- Acronym / sponsor ID
- TRIGGOSTEO-1
- Conditions
- Shoulder Pain
- Keywords
- trigger point, osteopathic palpation, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de NantesUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Adults (18 to 50 years old),
- affiliation to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathic palpationcomparaison of ultrasound caracteristics of areas with ad without TP | Diagnostic test | – |
Primary outcome
sensitivity and specificity of osteopathic tests
Time frame: at day 1
to compare osteopath TP detection to ultrasound echogenicity
2 secondary outcomes
Inter examiner reproductibility of TP detection
Time frame: at day 1
camparison of pain reported by patient with TP detection by osteopath
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Yes. on demand to m. salmon
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Institut des Hautes Etudes Osteopathiques de Nantes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime Salmon (+332 28 07 29 28, msalmon@idheo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of osteopathic tests (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.