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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05951218
Other study ID # TRIGGOSTEO-2
Secondary ID 2023-A00637-38
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 29, 2023
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Institut des Hautes Etudes Osteopathiques de Nantes
Contact Maxime Salmon, MSc
Phone +332 28 07 29 28
Email msalmon@idheo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 61
Est. completion date December 31, 2024
Est. primary completion date August 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - age between 18 and 50 years - be affiliated to a social security system or benefit from such a system. Exclusion Criteria: - pregnant or breast-feeding women - adults under guardianship - patients under protection - history of tegumentary or muscular damage in the area concerned - wish to stop the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
inhibition technique
Inhibition treatment consists of applying progressive pressure with the finger until resistance is felt. The patient should feel discomfort but not pain. They should stop when they consider that the trigger point has been sufficiently relaxed. All the techniques should last less than 5 minutes. Osteopaths will be trained to have a close strength during techniques. The number of Newton that will be apply will be decided during training with the investigator
placebo
The osteopath will perform a light touch on 4 areas for 30 seconds each time. The trigger point area must be lightly touched, followed by the upper part of the pectoralis major, the elbow and finally the anterior part of the opposite glenohumeral region. Osteopaths will be trained to have a close strength during techniques. The number of Newton that will be apply will be decided during training with the investigator with a palpatory pressure measurement tool. A proposition of 1N will be proposed to have a very light touch, without activating the C-tactile sensors.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut des Hautes Etudes Osteopathiques de Nantes

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline pain during palpation at 5 minutes change in pain will be assess with a 0 to 4 scale before and after techniques on each boxes. Pain in relation to a TP will be compared between patients from placebo arm and intervention arm 5 minutes before and 5 minutes after the treatment session
Secondary Change from baseline echogenicity at 5 minutes Echogenicity will be assess with a binary outcome (0 for normal echogenicity and 1 for hypoechogenicity) before and after techniques on each boxes. Echogenicity in relation to a TP will be compared between patients from placebo arm and intervention arm 5 minutes before and 5 minutes after the treatment session
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