Myofascial Pain SyndromesNCT06764212
Investigation of the Diagnostic Efficacy of the M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome
A study testing Ultrasound in people with Myofascial Pain Syndromes, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome, or MPS, is a prevalent musculoskeletal disorder, which is characterised by the presence of muscle pain and tenderness. The inflammation and microtrauma that are the consequence result in adhesions between the fascial layers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one active trigger point
- Moderate back pain lasting more than 3 months
- Diagnosis of MPS according to Travell and Simons diagnostic criteria
- Healthy volunteers
Who cannot join
- cervical disc disease
- Fibromyalgia
- Central or peripheral nerve disease
- Shoulder joint disease
- Malignancy
- Rheumatic disease
- those who had been treated for MPS within 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Bursa, 16320
Burcu Metin Ökmen
Nilufer, Bursa, 16110
About this study
Official title: Investigation of the Diagnostic Efficacy of the Amount of Fascial Sliding Measured by M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome
Myofascial pain syndrome, or MPS, is a prevalent musculoskeletal disorder, which is characterised by the presence of muscle pain and tenderness. The inflammation and microtrauma that are the consequence result in adhesions between the fascial layers. It has been reported that these adhesions prevent the fasciae from sliding over each other and contribute to pain.
Read the detailed description
The rhomboid and trapezius muscles are commonly involved in MPS, which often affects the upper extremity.
This study hypothesized that muscle sliding decreases in patients with MPS. To this end, the investigators measured the amount of fascial sliding of the trapezius muscle in healthy volunteers and patients with MPS using M-mode ultrasound and a software-assisted program to investigate the differences and diagnostic value.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Ultrasound
- Keywords
- pain, ultrasound
- Medical subject headings
- Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Also called M-Mode musculoskeletal ultrasound
M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements.
| Study group | Role | What they receive |
|---|---|---|
| mps | Active comparator | M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements. Receives: Diagnostic Test: Ultrasound |
| healthy volunteers | Active comparator | M-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
m-mode
The amount of displacement of the fascia under the Trapezius muscle during arm lift, neck lateral and anterior flexion, and shoulder lift in a sitting position and the M-mode ultrasonography image will be recorded. The measurements obtained from the recordings will be recorded.
Measured: 30 minutes
Secondary outcomes (4)
Trapezius and rhomboid muscle
Trapezius and rhomboid muscle thickness measurements will be made via ultrasound
Measured: 30 minutes
vas
Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: baseline
NPDS
Neck and Disability Scale (NPDS):
The 20-item Neck and Disability Scale is scored on a 10 cm visual analog scale and ranges from 0 to 5 points. The test aims to measure the impact of neck pain on quality of life, functionality, and disability
Measured: baseline
sf-12
The SF-12 form, which includes scales to assess physical (SF-12-PCS) and mental (SF-12-MCS) status, was created by taking 12 different items from 8 other titles of the SF-36, which is the extended version
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2020
- Primary completion1 Feb 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Burcu Metin Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764212
- Sponsor's protocol ID
- BursaYIEAH-2019-6-24
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Diagnostic Efficacy of the Amount of Fascial Sliding Measured by M-Mode Ultrasonography in the Diagnosis of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06764212
- Acronym / sponsor ID
- BursaYIEAH-2019-6-24
- Conditions
- Myofascial Pain Syndromes
- Keywords
- pain, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Jan 2025 (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.
Myofascial pain syndrome, or MPS, is a prevalent musculoskeletal disorder, which is characterised by the presence of muscle pain and tenderness. The inflammation and microtrauma that are the consequence result in adhesions between the fascial layers. It has been reported that these adhesions prevent the fasciae from sliding over each other and contribute to pain.
Detailed description
The rhomboid and trapezius muscles are commonly involved in MPS, which often affects the upper extremity.
This study hypothesized that muscle sliding decreases in patients with MPS. To this end, the investigators measured the amount of fascial sliding of the trapezius muscle in healthy volunteers and patients with MPS using M-mode ultrasound and a software-assisted program to investigate the differences and diagnostic value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mps | Active comparator | Diagnostic Test: UltrasoundM-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements. |
| healthy volunteers | Active comparator | Diagnostic Test: UltrasoundM-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least one active trigger point
- Moderate back pain lasting more than 3 months
- Diagnosis of MPS according to Travell and Simons diagnostic criteria
- Healthy volunteers
Key exclusion criteria (7 listed)
- cervical disc disease
- Fibromyalgia
- Central or peripheral nerve disease
- Shoulder joint disease
- Malignancy
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 |
|---|---|---|
| UltrasoundAlso: M-Mode musculoskeletal ultrasoundM-mode ultrasonography images of the fascia under the trapezius muscle will be recorded during 3 different movements. | Diagnostic test | healthy volunteers, mps |
Primary outcome
m-mode
Time frame: 30 minutes
The amount of displacement of the fascia under the Trapezius muscle during arm lift, neck lateral and anterior flexion, and shoulder lift in a sitting position and the M-mode ultrasonography image will be recorded. The measurements obtained from the recordings will be recorded.
4 secondary outcomes
Trapezius and rhomboid muscle
Time frame: 30 minutes
vas
Time frame: baseline
NPDS
Time frame: baseline
sf-12
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Myofascial Pain Syndromes, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
m-mode (time frame: 30 minutes). 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 9 Jan 2025.