Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
Primary Purpose
Shoulder Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inhibition technique
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring trigger point, osteopathic palpation, ultrasound
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
inhibition technique
placebo
Arm Description
In the first group, patients will receive inhibition treatment of the TP.
The second group will receive a placebo treatment.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05951218
First Posted
July 9, 2023
Last Updated
July 15, 2023
Sponsor
Institut des Hautes Etudes Osteopathiques de Nantes
1. Study Identification
Unique Protocol Identification Number
NCT05951218
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 29, 2023 (Anticipated)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut des Hautes Etudes Osteopathiques de Nantes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
trigger point, osteopathic palpation, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inhibition technique
Arm Type
Experimental
Arm Description
In the first group, patients will receive inhibition treatment of the TP.
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
The second group will receive a placebo treatment.
Intervention Type
Other
Intervention Name(s)
inhibition technique
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline pain during palpation at 5 minutes
Description
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
Time Frame
5 minutes before and 5 minutes after the treatment session
Secondary Outcome Measure Information:
Title
Change from baseline echogenicity at 5 minutes
Description
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
Time Frame
5 minutes before and 5 minutes after the treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Salmon, MSc
Phone
+332 28 07 29 28
Email
msalmon@idheo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
on demand to M. Salmon
Learn more about this trial
Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
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