Myofascial Pain SyndromeNCT04751110
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome
A study testing ultrasound guided rhomboid intercostal block in people with Myofascial Pain Syndrome, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- ultrasound guided rhomboid intercostal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 26 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaint of myofascial pain
- Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)
Who cannot join
- pregnancy
- the presence of coagulopathy, or the use of anticoagulants
- a history of surgery on the block area
- allergic to bupivacaine
- decline to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome: Observational Study
Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. Recently published report has shown that rhomboid intercostal block (RIB) may provide effective pain control for myofascial pain syndrome (MPS), too. MPS is a regional pain syndrome characterized by trigger points detected in one or more regional muscle groups. The investigators planned a prospective observational study, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcomes.
Read the detailed description
Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. The investigators planned a prospective observational study.From february to march 10 2021, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcome Ultrasound guided RIB will applied with linear probe, in plane technique. Block needle was inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 13ml of bupivacaine 0.25% and 8mg dexamethasone mixture will inject into the fascial plane. Numerical Rating Scale (NRS) will recorded before and after the block at 30 minutes, day 1, 1-2-4-6 weeks.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- ultrasound guided rhomboid intercostal block
- Keywords
- rhomboid intercostal block, ultrasound guided block
- 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.
ultrasound guided rhomboid intercostal blockOther
A linear ultrasound probe was medially placed in the sagittal plane on the medial border of the scapula at the T5-T7 level. We inserted a 22-gauge needle into the fascial plane between the rhomboid major and intercostal muscles in a craniocaudal direction and injected 15 ml mixture of 0.25% bupivacaine with 8 mg of dexamethasone into the fascial plane.
| Study group | Role | What they receive |
|---|---|---|
| block group | Other | ultrasound guided rhomboid intercostal block will performed Receives: Other: ultrasound guided rhomboid intercostal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain Score Change
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start10 Feb 2021
- Primary completion15 Mar 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Guven Kose, Diskapi Teaching and Research Hospital
- Investigators
- Selin Guven Kose, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751110
- Sponsor's protocol ID
- 98/05
- Status last verified
- Nov 2021
- First submitted
- 5 Feb 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.
PubMed 24787338Ekinci M, Ciftci B, Alici HA, Ahiskalioglu A. Ultrasound-guided rhomboid intercostal block effectively manages myofascial pain. Korean J Anesthesiol. 2020 Dec;73(6):564-565. doi: 10.4097/kja.20211. Epub 2020 May 12. No abstract available.
PubMed 32392670Piraccini E, De Lorenzo E, Maitan S. Rhomboid intercostal block for myofascial pain syndrome in a patient with amyotrophic lateral sclerosis. Minerva Anestesiol. 2019 Dec;85(12):1367-1369. doi: 10.23736/S0375-9393.19.13791-1. Epub 2019 Jul 22. No abstract available.
PubMed 31334619Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
PubMed 27291611
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome: Observational Study
- ClinicalTrials.gov ID
- NCT04751110
- Acronym / sponsor ID
- 98/05
- Conditions
- Myofascial Pain Syndrome
- Keywords
- rhomboid intercostal block, ultrasound guided block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 11 Feb 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.
Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. Recently published report has shown that rhomboid intercostal block (RIB) may provide effective pain control for myofascial pain syndrome (MPS), too. MPS is a regional pain syndrome characterized by trigger points detected in one or more regional muscle groups. The investigators planned a prospective observational study, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcomes.
Detailed description
Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. The investigators planned a prospective observational study.From february to march 10 2021, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcome Ultrasound guided RIB will applied with linear probe, in plane technique. Block needle was inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 13ml of bupivacaine 0.25% and 8mg dexamethasone mixture will inject into the fascial plane. Numerical Rating Scale (NRS) will recorded before and after the block at 30 minutes, day 1, 1-2-4-6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| block group | Other | Other: ultrasound guided rhomboid intercostal blockultrasound guided rhomboid intercostal block will performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complaint of myofascial pain
- Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)
Key exclusion criteria (5 listed)
- pregnancy
- the presence of coagulopathy, or the use of anticoagulants
- a history of surgery on the block area
- allergic to bupivacaine
- decline to participate
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 |
|---|---|---|
| ultrasound guided rhomboid intercostal blockA linear ultrasound probe was medially placed in the sagittal plane on the medial border of the scapula at the T5-T7 level. We inserted a 22-gauge needle into the fascial plane between the rhomboid major and intercostal muscles in a craniocaudal direction and injected 15 ml mixture of 0.25% bupivacaine with 8 mg of dexamethasone into the fascial plane. | Other | block group |
Primary outcome
Numerical Rating Scale (NRS) Pain Score Change
Time frame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
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 15 Nov 2021.
- Background: PubMed 24787338Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.
- Background: PubMed 32392670Ekinci M, Ciftci B, Alici HA, Ahiskalioglu A. Ultrasound-guided rhomboid intercostal block effectively manages myofascial pain. Korean J Anesthesiol. 2020 Dec;73(6):564-565. doi: 10.4097/kja.20211. Epub 2020 May 12. No abstract available.
- Background: PubMed 31334619Piraccini E, De Lorenzo E, Maitan S. Rhomboid intercostal block for myofascial pain syndrome in a patient with amyotrophic lateral sclerosis. Minerva Anestesiol. 2019 Dec;85(12):1367-1369. doi: 10.23736/S0375-9393.19.13791-1. Epub 2019 Jul 22. No abstract available.
- Background: PubMed 27291611Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
- Individual participant dataSharing planned: No
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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.
Selin Guven Kose principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided rhomboid intercostal block in people with Myofascial Pain Syndrome, run by Diskapi Teaching and Research Hospital at 1 site 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 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: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Numerical Rating Scale (NRS) Pain Score Change (time frame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751110, which also lists 4 linked publications.
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 15 Nov 2021.