Shoulder PainNCT05951218
Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain
A study testing inhibition technique in people with Shoulder Pain, run by Institut des Hautes Etudes Osteopathiques de Nantes.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- inhibition technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 50 years
- be affiliated to a social security system or benefit from such a system.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- inhibition technique, placebo
- Keywords
- trigger point, osteopathic palpation, ultrasound
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhibition techniqueOther
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
placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| inhibition technique | Experimental | In the first group, patients will receive inhibition treatment of the TP. Receives: Other: inhibition technique |
| placebo | Sham comparator | The second group will receive a placebo treatment. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes before and 5 minutes after the treatment session
Secondary outcomes (1)
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
Measured: 5 minutes before and 5 minutes after the treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start29 Aug 2023 (estimated)
- Primary completion29 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de Nantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951218
- Sponsor's protocol ID
- TRIGGOSTEO-2
- Other IDs
- 2023-A00637-38
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: on demand to M. Salmon
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation
- ClinicalTrials.gov ID
- NCT05951218
- Acronym / sponsor ID
- TRIGGOSTEO-2
- Conditions
- Shoulder Pain
- Keywords
- trigger point, osteopathic palpation, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de NantesUniversity, hospital or other
- Study start
- 29 Aug 2023 (estimated)
- Primary completion
- 29 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhibition technique | Experimental | Other: inhibition techniqueIn the first group, patients will receive inhibition treatment of the TP. |
| placebo | Sham comparator | Other: placeboThe second group will receive a placebo treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 50 years
- be affiliated to a social security system or benefit from such a system.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhibition techniqueInhibition 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 | Other | inhibition technique |
| placeboThe 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. | Other | placebo |
Primary outcome
Change from baseline pain during palpation at 5 minutes
Time frame: 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
1 secondary outcome
Change from baseline echogenicity at 5 minutes
Time frame: 5 minutes before and 5 minutes after the treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Yes. on demand to M. Salmon
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing inhibition technique in people with Shoulder Pain, run by Institut des Hautes Etudes Osteopathiques de Nantes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime Salmon, MSc (+332 28 07 29 28, msalmon@idheo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain during palpation at 5 minutes (time frame: 5 minutes before and 5 minutes after the treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.