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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
Institut des Hautes Etudes Osteopathiques de Nantes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring trigger point, osteopathic palpation, ultrasound

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 9, 2023
    Last Updated
    July 15, 2023
    Sponsor
    Institut des Hautes Etudes Osteopathiques de Nantes
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    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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