Myofascial Pain SyndromeNCT05359523
Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome
A study testing Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia and fascia injection in people with Myofascial Pain Syndrome, run by Bursa Yuksek Ihtisas Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia and fascia injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Aug 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
- 18-65 years old
- myofascial pain syndrome
Who cannot join
- Cervical radiculopathy
- Fibromyalgia
- Shoulder joint disease,
- Peripheral and central nervous system disease
- Polyneuropathy,
- Inflammatory rheumatic disease,
- Malignancy
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 Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome
Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.
Read the detailed description
In this study, the role of the thickness of these muscles and the shift during movement in the activity and diagnosis of the disease in myofascial pain syndrome will be investigated.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia, fascia injection
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic measurements of the trapezius and rhomboid muscle and fasciaDevice
B mode measurements Trapezius and rhomboid muscle thickness and fascial thickness measurement M mode measurements Abduction at 90 and 180 degrees Forward flexion at 90 and 180 degrees
fascia injectionOther
Under ultrasound guidance, a local anesthetic and steroid mixture will be injected into the fascia between the trapezius muscle and the rhomboid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with myofascial pain syndrome | Active comparator | Ultrasound measurements will be made while the upper back is at rest and during arm movements. Receives: Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia; Other: fascia injection |
| Healthy volunteers | Active comparator | Ultrasound measurements will be made while the upper back is at rest and during arm movements. Receives: Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trapezius muscle and rhomboid muscle thickness
Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
Measured: 20 minute
fascial sliding
Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements.
ultrasonography M-mode measurements Arm from the shoulder joint, cervical lateral flexion, cervical anterior flexion, shoulder elevation
Measured: 20 minute
Secondary outcomes (3)
VAS
visual analog scale (VAS) :for pain. 0: no pain at all, 10: worst pain imaginable
Measured: 6 th month
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: 6th month
SF-12
Short Form 12 (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.
Interpretation of Scores:
Utilize the norm-based scoring system to interpret PCS and MCS scores, with a mean of 50 and a standard deviation of 10 in the general population.
Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 May 2021
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- Investigators
- Korgün Ökmen, Assoc. PhD., Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359523
- Sponsor's protocol ID
- 2021/10-16
- Status last verified
- Jan 2025
- First submitted
- 27 Apr 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Diagnostic Effect of Ultrasonographic Measurement Values of Upper Back Muscles and Fascia in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05359523
- Acronym / sponsor ID
- 2021/10-16
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 4 May 2022 (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.
Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.
Detailed description
In this study, the role of the thickness of these muscles and the shift during movement in the activity and diagnosis of the disease in myofascial pain syndrome will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with myofascial pain syndrome | Active comparator | Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia, Other: fascia injectionUltrasound measurements will be made while the upper back is at rest and during arm movements. |
| Healthy volunteers | Active comparator | Device: Ultrasonographic measurements of the trapezius and rhomboid muscle and fasciaUltrasound measurements will be made while the upper back is at rest and during arm movements. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-65 years old
- myofascial pain syndrome
Key exclusion criteria (7 listed)
- Cervical radiculopathy
- Fibromyalgia
- Shoulder joint disease,
- Peripheral and central nervous system disease
- Polyneuropathy,
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 |
|---|---|---|
| Ultrasonographic measurements of the trapezius and rhomboid muscle and fasciaB mode measurements Trapezius and rhomboid muscle thickness and fascial thickness measurement M mode measurements Abduction at 90 and 180 degrees Forward flexion at 90 and 180 degrees | Device | Healthy volunteers, Patients diagnosed with myofascial pain syndrome |
| fascia injectionUnder ultrasound guidance, a local anesthetic and steroid mixture will be injected into the fascia between the trapezius muscle and the rhomboid muscle. | Other | Patients diagnosed with myofascial pain syndrome |
Primary outcome
Trapezius muscle and rhomboid muscle thickness
Time frame: 20 minute
Trapezius and rhomboid muscle thickness and fascial thickness measurement will be made by ultrasonography at rest.
fascial sliding
Time frame: 20 minute
Measurements of the amount of slip measured during the movement of the fascial structures during shoulder and arm movements. ultrasonography M-mode measurements Arm from the shoulder joint, cervical lateral flexion, cervical anterior flexion, shoulder elevation
3 secondary outcomes
VAS
Time frame: 6 th month
NPDS
Time frame: 6th month
SF-12
Time frame: 6th month
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 7 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.
Korgün Ökmen, Assoc. PhD. study chair
Bursa Yuksek Ihtisas Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic measurements of the trapezius and rhomboid muscle and fascia and fascia injection in people with Myofascial Pain Syndrome, 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 2 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 7 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?
Trapezius muscle and rhomboid muscle thickness (time frame: 20 minute). The study lists 2 primary outcomes in all. 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 7 Jan 2025.