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

Sponsor

Institut des Hautes Etudes Osteopathiques de Nantes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05951218

Collaborator

(none)

Enrollment

Arms

16.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Other: inhibition technique Other: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 29, 2023

Anticipated Primary Completion Date :

Aug 29, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline pain during palpation at 5 minutes [5 minutes before and 5 minutes after the treatment session]
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

Secondary Outcome Measures

Change from baseline echogenicity at 5 minutes [5 minutes before and 5 minutes after the treatment session]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institut des Hautes Etudes Osteopathiques de Nantes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut des Hautes Etudes Osteopathiques de Nantes

ClinicalTrials.gov Identifier:

NCT05951218

Other Study ID Numbers:

TRIGGOSTEO-2
2023-A00637-38

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 18, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut des Hautes Etudes Osteopathiques de Nantes

trigger point

osteopathic palpation

ultrasound

Additional relevant MeSH terms:

Shoulder Pain

Study Results

No Results Posted as of Jul 18, 2023