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

NCT ID: NCT05951218

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-29
• Study Completion Date: 2024-12-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

inhibition technique

In the first group, patients will receive inhibition treatment of the TP.

Group Type: EXPERIMENTAL

inhibition technique

Intervention Type: OTHER

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 second group will receive a placebo treatment.

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut des Hautes Etudes Osteopathiques de Nantes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Maxime Salmon, MSc

Role: CONTACT

msalmon@idheo.com

+332 28 07 29 28

Other Identifiers

2023-A00637-38

Identifier Type: OTHER

Identifier Source: secondary_id

TRIGGOSTEO-2

Identifier Type: -

Identifier Source: org_study_id