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

NCT05951218 | Unknown

• 2 other identifiers: TRIGGOSTEO-22023-A00637-38
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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

Keywords

trigger point; osteopathic palpation; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline echogenicity at 5 minutes

  5 minutes before and 5 minutes after the treatment session

Study Arms (2)

inhibition technique

EXPERIMENTAL

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

Other: inhibition technique

placebo

SHAM COMPARATOR

The second group will receive a placebo treatment.

Other: placebo

Interventions

inhibition technique 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

inhibition technique

placebo 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.

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 50 years
• be affiliated to a social security system or benefit from such a system.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut des Hautes Etudes Osteopathiques de Nantes: lead

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maxime Salmon, MSc

CONTACT

+332 28 07 29 28; msalmon@idheo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 18, 2023
• Study Start: August 29, 2023
• Primary Completion: August 29, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE