Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05951218
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
Sponsor:
Institut des Hautes Etudes Osteopathiques de Nantes
Organization:
Study Overview
Official Title:
Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trigger points (TP) are described as "hard, palpable nodules located within the taut bands of skeletal muscle".
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. All included osteopaths will receive a formation to test and treat with the same approach and the same strength during all stages.
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 echogenicity of every box and will be blinded to the prior results.
Every patient with a TP diagnosed by the first osteopath, will be randomised into two groups (inhibition of trigger point technique with a long standing press on the TP, placebo technique with four light touch techniques on both shoulders, sternum and rachis).
The second osteopath will evaluate the same boxes and will be blinded to the randomisation process. At each step of palpation, a pain assessment will be carried out at each box.
The ultrasound technician will evaluate an other time the echogenicity of every box and will be blinded to the prior results, and randomisation.
A blinded statistician will evaluate the efficacy of inhibition technique on echogenicity and patients' pain during the tests.
The protocol has been approved by a french ethic committee.
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. All included osteopaths will receive a formation to test and treat with the same approach and the same strength during all stages.
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 echogenicity of every box and will be blinded to the prior results.
Every patient with a TP diagnosed by the first osteopath, will be randomised into two groups (inhibition of trigger point technique with a long standing press on the TP, placebo technique with four light touch techniques on both shoulders, sternum and rachis).
The second osteopath will evaluate the same boxes and will be blinded to the randomisation process. At each step of palpation, a pain assessment will be carried out at each box.
The ultrasound technician will evaluate an other time the echogenicity of every box and will be blinded to the prior results, and randomisation.
A blinded statistician will evaluate the efficacy of inhibition technique on echogenicity and patients' pain during the tests.
The protocol has been approved by a french ethic committee.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-A00637-38 | OTHER | Agence nationale de sécurité du médicament et produits de santé | View |