Myofascial Pain SyndromeNCT05022888
Near-Infrared Spectroscopy in Myofascial Pain Syndrome
A study testing regional tissue saturation in people with Myofascial Pain Syndrome and Regional Tissue Oxygen Saturation, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Myofascial pain syndrome is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome, Regional Tissue Oxygen Saturation
- What is being tested?
- regional tissue saturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2021to 30 Nov 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
No sites are listed yet.
About this study
Official title: Investigation of the Diagnostic Effect of Muscle Tissue Oxygenation Values in Patients With Myofascial Pain Syndrome
Myofascial pain syndrome is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. Myofascial pain syndrome is characterized by active myofascial trigger points in the form of focal hyperirritable nodules palpated in the tight band of the muscle .
Alteration of tissue vascularization could limit or prevent th may cause adhesions, contractures and pain. As a result of decreased blood flow, tissue oxygenation may decrease.
Read the detailed description
In this study, it will be tried to determine the role of muscle tissue oxygenation in the activity and diagnosis of the disease in myofascial pain syndrome.
- Being tested
- regional tissue saturation
- 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.
regional tissue saturationDevice
tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
| Study group | Role | What they receive |
|---|---|---|
| myofascial pain syndrome | Active comparator | Patients diagnosed with myofascial pain syndrome Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle Receives: Device: regional tissue saturation |
| Healthy volunteers | Active comparator | Healthy volunteers Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle Receives: Device: regional tissue saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional tissue saturation
tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
Measured: 15 minute
Secondary outcomes (2)
peripheral oxygen saturation
A pulse oximeter will be used to measure peripheral oxygen saturation
Measured: 15 minute
Visual Analogue Scale (VAS)
for pain. 0: no pain at all, 10: worst pain imaginable
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start23 Aug 2021 (estimated)
- Primary completion23 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
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
- Model description
- prospective
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- Burcu M.D Metin ÖKMEN, Assoc. PhD., Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalKorgün MD Ökmen, Assoc. PhD., Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022888
- Sponsor's protocol ID
- BYIERH3
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2021
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Diagnostic Effect of Muscle Tissue Oxygenation Values in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05022888
- Acronym / sponsor ID
- BYIERH3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 23 Aug 2021 (estimated)
- Primary completion
- 23 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 26 Aug 2021 (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 is a regional pain syndrome accompanied by sensorial, motor and autonomic symptoms . myofascial trigger points are most frequently detected in the upper trapezius, levator scapula, and axial postural muscles such as rhomboid major. Myofascial pain syndrome is characterized by active myofascial trigger points in the form of focal hyperirritable nodules palpated in the tight band of the muscle .
Alteration of tissue vascularization could limit or prevent th may cause adhesions, contractures and pain. As a result of decreased blood flow, tissue oxygenation may decrease.
Detailed description
In this study, it will be tried to determine the role of muscle tissue oxygenation in the activity and diagnosis of the disease in myofascial pain syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective
| Arm | Type | Receives |
|---|---|---|
| myofascial pain syndrome | Active comparator | Device: regional tissue saturationPatients diagnosed with myofascial pain syndrome Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle |
| Healthy volunteers | Active comparator | Device: regional tissue saturationHealthy volunteers Tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| regional tissue saturationtissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas. | Device | Healthy volunteers, myofascial pain syndrome |
Primary outcome
regional tissue saturation
Time frame: 15 minute
tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
2 secondary outcomes
peripheral oxygen saturation
Time frame: 15 minute
Visual Analogue Scale (VAS)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
Burcu M.D Metin ÖKMEN, Assoc. PhD. principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Korgün MD Ökmen, Assoc. PhD. study chair
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing regional tissue saturation in people with Myofascial Pain Syndrome and Regional Tissue Oxygen Saturation, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. 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. 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 Burcu M.D Metin ÖKMEN, Assoc. PhD. (+902242955000, burcumetinokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regional tissue saturation (time frame: 15 minute). 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 30 Aug 2021.