Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain

Shoulder Pain Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Shoulder Pain

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