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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: inhibition technique; Other: placebo

• Study Type: Interventional
• Enrollment (Estimated): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime Salmon, MSc; Phone Number: +332 28 07 29 28; Email: msalmon@idheo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inhibition technique; In the first group, patients will receive inhibition treatment of the TP.	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
Sham Comparator: placebo; The second group will receive a placebo treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut des Hautes Etudes Osteopathiques de Nantes

Study record dates

Study Major Dates

• Study Start (Estimated): August 29, 2023
• Primary Completion (Estimated): August 29, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; trigger point; osteopathic palpation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: TRIGGOSTEO-2; 2023-A00637-38 (Other Identifier: Agence nationale de sécurité du médicament et produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: on demand to M. Salmon
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No