Clinical trial NCT05951218: Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
Official title: Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: trigger point
osteopathic palpation
ultrasound
Lead sponsor: Institut des Hautes Etudes Osteopathiques de Nantes
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pain during palpation at 5 minutes
timeFrame: 5 minutes before and 5 minutes after the treatment session
Secondary outcomes:
measure: Change from baseline echogenicity at 5 minutes
timeFrame: 5 minutes before and 5 minutes after the treatment session
Other outcomes:
Locations:
Study officials:
References: