Myofascial PainNCT06029413
Myo vs. Myofascial Injection for Myofascial Trigger Points
A study testing myo + fascial injection and traditional trigger point injection in people with Myofascial Pain and Myofascial Trigger Point Pain, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effectiveness of two different application methods that can be used in myofascial trigger point injection treatment will be compared. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain, Myofascial Trigger Point Pain, Trigger Point Pain, Myofascial
- What is being tested?
- myo + fascial injection and traditional trigger point injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2023to 25 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in the upper back area
- Detection of active trigger point in upper back muscles (trapezius, levator scapula, rhomboids, supraspinatus and infraspinatus)
- Presence of at least two of the three criteria recommended for the diagnosis of trigger point:
- Taut band
- Hypersensitive point
- Referred pain
- Pain VAS score ≥ 4
- Between the ages of 18-65 -
Who cannot join
- Using analgesics or anti-inflammatory medicines.
- Having received physical therapy for the same symptoms in the past 3 months
- Serious psychiatric illness
- Presence of malignancy or infection
- Coagulation disorder
- Pregnancy
Show all 10Show fewer
- History of operation in the relevant region
- Presence of fibromyalgia syndrome
- History of allergy to local anesthetics
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Education and Research Hospital
Izmir
About this study
Official title: Myo Vs. Myofascial Injection for Myofascial Trigger Points. Is There Really a Difference? A Randomized Controlled Trial
In this study, the effectiveness of two different application methods that can be used in myofascial trigger point injection treatment will be compared.
Read the detailed description
This study aims to compare the intramuscular trigger point injection, which is traditionally used in the treatment of myofascial trigger points with the method in which facial layers are also included in the application.
- Being tested
- myo + fascial injection, traditional trigger point injection
- Keywords
- usg-guided trigger point injections, myofascial pain, myofascial trigger point, fascial hydrodilatation
- 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.
myo + fascial injectionProcedure or surgery
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described.
traditional trigger point injectionProcedure or surgery
10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described.
| Study group | Role | What they receive |
|---|---|---|
| Research arm | Experimental | After the myofascial trigger points are determined by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan), injections will be given to the myofascial layers from the deep to the superficial. First, the local anesthetic solution will be injected to create a separation in the intermuscle (epimysial) fascia. The injectable will then be infiltrated into the intermuscular hypoechoic nodule. Then, the deep fascia will be infiltrated layer by layer. Finally, the procedure will be completed by infiltrating the superficial fascia. Receives: Procedure: myo + fascial injection |
| Control arm | Active comparator | Patients in the control group will be injected with the same amount of local anesthetic solution under ultrasound guidance to intramuscular hypoechoic nodules detected by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan). Receives: Procedure: traditional trigger point injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(Visual Analog Scale)
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
Measured: Baseline
VAS(Visual Analog Scale)
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
Measured: 30 minutes after intervention
VAS(Visual Analog Scale)
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
Measured: 72 hours after intervention
VAS(Visual Analog Scale)
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
Measured: 1 week after intervention
Secondary outcomes (7)
Pressure Pain Threshold
The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold
Measured: Baseline
Pressure Pain Threshold
The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold
Measured: 30 minutes after intervention
Pressure Pain Threshold
The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold
Measured: 72 hours after intervention
Pressure Pain Threshold
The Baseline 1200-303 (Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) algometer will be used to measure pressure pain threshold. The Baseline 1200-3031 cm2 is a dynamometer applied with a flat tip. The device is brought into contact with the skin at an angle of 90º and a force is applied to provide an increase of 1 kg per second. The first value at which the patient feels the sensation of pain is recorded. The average of 3 measurements taken at 30-second intervals is recorded as the patient's pressure pain threshold
Measured: 1 week after intervention
Functional Status
The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown.
Measured: Baseline
Functional Status
The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown.
Measured: 72 hours after intervention
Functional Status
The change in the functional status of the patients will be evaluated with the neck disability index (NDI). NDI is a 10-question questionnaire most commonly used to evaluate nonspecific mechanical neck pain. A total score between 0 and 50 is obtained by scoring each question between 0 (no disability) and 5 (complete disability). The validity and reliability study of the Turkish version of the scale was shown.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 Sep 2023
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myofascial 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
- Model description
- This study is planned to compare the effects of USG guided intramuscular trigger point injection with the effects of USG guided intramuscular plus fascial trigger point injection. This is a single-center randomized trial with 2 parallel arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğra İnce, Bozyaka Training and Research Hospital
- Investigators
- Buğra İnce, Study director, Izmir Bozyaka Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029413
- Sponsor's protocol ID
- SOY23
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricci V, Ricci C, Mezian K, Nanka O, Ozcakar L. Trapezius Muscle and the Cutaneous Branches of Spinal Nerves: Sonographic/Anatomic Discussion of Myofascial Pain and Superficial Injections. Pain Med. 2023 Mar 1;24(3):221-225. doi: 10.1093/pm/pnac125. No abstract available.
PubMed 35980166Ricci V, Ricci C, Gervasoni F, Cocco G, Andreoli A, Ozcakar L. From Histoanatomy to Sonography in Myofascial Pain Syndrome: A EURO-MUSCULUS/USPRM Approach. Am J Phys Med Rehabil. 2023 Jan 1;102(1):92-97. doi: 10.1097/PHM.0000000000001975. Epub 2022 Jan 21.
PubMed 35067549Pirri C, Pirri N, Guidolin D, Macchi V, De Caro R, Stecco C. Ultrasound Imaging of the Superficial Fascia in the Upper Limb: Arm and Forearm. Diagnostics (Basel). 2022 Aug 4;12(8):1884. doi: 10.3390/diagnostics12081884.
PubMed 36010234Nouged E, Dajani J, Ku B, Al-Eryani K, Padilla M, Enciso R. Local Anesthetic Injections for the Short-Term Treatment of Head and Neck Myofascial Pain Syndrome: A Systematic Review with Meta-Analysis. J Oral Facial Pain Headache. 2019 Spring;33(2):183-198. doi: 10.11607/ofph.2277. Epub 2019 Mar 20.
PubMed 30893405Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38.
PubMed 22852442
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myo Vs. Myofascial Injection for Myofascial Trigger Points. Is There Really a Difference? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06029413
- Acronym / sponsor ID
- SOY23
- Keywords
- usg-guided trigger point injections, myofascial pain, myofascial trigger point, fascial hydrodilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 8 Sep 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.
In this study, the effectiveness of two different application methods that can be used in myofascial trigger point injection treatment will be compared.
Detailed description
This study aims to compare the intramuscular trigger point injection, which is traditionally used in the treatment of myofascial trigger points with the method in which facial layers are also included in the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is planned to compare the effects of USG guided intramuscular trigger point injection with the effects of USG guided intramuscular plus fascial trigger point injection. This is a single-center randomized trial with 2 parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Research arm | Experimental | Procedure: myo + fascial injectionAfter the myofascial trigger points are determined by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan), injections will be given to the myofascial layers from the deep to the superficial. First, the local anesthetic solution will be injected to create a separation in the intermuscle (epimysial) fascia. The injectable will then be infiltrated into the intermuscular hypoechoic nodule. Then, the deep fascia will be infiltrated layer by layer. Finally, the procedure will be completed by infiltrating the superficial fascia. |
| Control arm | Active comparator | Procedure: traditional trigger point injectionPatients in the control group will be injected with the same amount of local anesthetic solution under ultrasound guidance to intramuscular hypoechoic nodules detected by ultrasonography (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pain in the upper back area
- Detection of active trigger point in upper back muscles (trapezius, levator scapula, rhomboids, supraspinatus and infraspinatus)
- Presence of at least two of the three criteria recommended for the diagnosis of trigger point:
- Taut band
- Hypersensitive point
Key exclusion criteria (10 listed)
- Using analgesics or anti-inflammatory medicines.
- Having received physical therapy for the same symptoms in the past 3 months
- Serious psychiatric illness
- Presence of malignancy or infection
- Coagulation disorder
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 |
|---|---|---|
| myo + fascial injection10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as well as for fascial layers as described. | Procedure or surgery | Research arm |
| traditional trigger point injection10 cc 0.5 % lidocain solution injection for intermuscular hypersensitive nodule as described. | Procedure or surgery | Control arm |
Primary outcome
VAS(Visual Analog Scale)
Time frame: Baseline
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
VAS(Visual Analog Scale)
Time frame: 30 minutes after intervention
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
VAS(Visual Analog Scale)
Time frame: 72 hours after intervention
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
VAS(Visual Analog Scale)
Time frame: 1 week after intervention
Pain intensity will be evaluated with the visual analog scale (VAS). VAS is a scale used to digitize subjective values such as behavior or characteristics that cannot be measured directly. Two end definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line (0. : no pain, 10: very severe pain)
7 secondary outcomes
Pressure Pain Threshold
Time frame: Baseline
Pressure Pain Threshold
Time frame: 30 minutes after intervention
Pressure Pain Threshold
Time frame: 72 hours after intervention
Pressure Pain Threshold
Time frame: 1 week after intervention
Functional Status
Time frame: Baseline
Functional Status
Time frame: 72 hours after intervention
Functional Status
Time frame: 1 week after intervention
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 28 Aug 2024.
- Background: PubMed 35980166Ricci V, Ricci C, Mezian K, Nanka O, Ozcakar L. Trapezius Muscle and the Cutaneous Branches of Spinal Nerves: Sonographic/Anatomic Discussion of Myofascial Pain and Superficial Injections. Pain Med. 2023 Mar 1;24(3):221-225. doi: 10.1093/pm/pnac125. No abstract available.
- Background: PubMed 35067549Ricci V, Ricci C, Gervasoni F, Cocco G, Andreoli A, Ozcakar L. From Histoanatomy to Sonography in Myofascial Pain Syndrome: A EURO-MUSCULUS/USPRM Approach. Am J Phys Med Rehabil. 2023 Jan 1;102(1):92-97. doi: 10.1097/PHM.0000000000001975. Epub 2022 Jan 21.
- Background: PubMed 36010234Pirri C, Pirri N, Guidolin D, Macchi V, De Caro R, Stecco C. Ultrasound Imaging of the Superficial Fascia in the Upper Limb: Arm and Forearm. Diagnostics (Basel). 2022 Aug 4;12(8):1884. doi: 10.3390/diagnostics12081884.
- Background: PubMed 30893405Nouged E, Dajani J, Ku B, Al-Eryani K, Padilla M, Enciso R. Local Anesthetic Injections for the Short-Term Treatment of Head and Neck Myofascial Pain Syndrome: A Systematic Review with Meta-Analysis. J Oral Facial Pain Headache. 2019 Spring;33(2):183-198. doi: 10.11607/ofph.2277. Epub 2019 Mar 20.
- Background: PubMed 22852442Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38.
- 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.
Buğra İnce study director
Izmir Bozyaka 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 myo + fascial injection and traditional trigger point injection in people with Myofascial Pain and Myofascial Trigger Point Pain, run by Bozyaka Training 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 8 inclusion and 10 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 28 Aug 2024. 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?
VAS(Visual Analog Scale) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT06029413, which also lists 5 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 28 Aug 2024.