Myofascial Pain SyndromeNCT05776199
Myofascial Trigger Points of the Levator Scapulae Muscle
A study testing Sonoelastography, tensiomyography and mechanosensitivity in people with Myofascial Pain Syndrome, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
Chronic neck pain (CNP) is considered one of the most common musculoskeletal disorders worldwide and myofascial pain syndrome (MPS) is the most prevalent musculoskeletal disorder in the majority of the population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Sonoelastography, tensiomyography and mechanosensitivity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 28 Dec 2022
- 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
- Bilateral presence of at least one active trigger point.
- One control point and one latent trigger point in the levator scapulae muscles.
- Subjects aged between 18 and 65 years.
- Subjects diagnosed with chronic neck pain for more than 6 weeks.
- Signed informed consent to be able to participate in the study.
Who cannot join
- Previous treatment for chronic neck pain (within one year) or medical history with a diagnosis of neuropathy.
- Rheumatoid arthritis.
- Myopathy.
- Cognitive impairment or mental disability.
- Skin disorders.
- Pregnancy.
Show all 9Show fewer
- Activity level of a high-level athlete.
- Medical conditions (fractures, structural deformities and neoplasms).
- Surgical interventions in the cervical-dorsal region or upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonoelastography, Tensiomyography and Mechanosensitivity Between Latent, Active and Control Trigger Points in Myofascial Trigger Points of the Levator Scapulae Muscle.
Chronic neck pain (CNP) is considered one of the most common musculoskeletal disorders worldwide and myofascial pain syndrome (MPS) is the most prevalent musculoskeletal disorder in the majority of the population. However, normal tissue contractility changes and the different types of myofascial trigger points (MTrPs) measured by tensiomography have not yet been studied. For this reason, the aim of our study is to determine the differences in pressure pain threshold (PPT), tensiomyography and sonoelastography between the palpation zone of control points with respect to active and latent MTrPs in the levator scapulae muscles of subjects with CNP. A single-blind descriptive cross-sectional study is conducted with a convenience sample of 60 points (20 active, 20 latent and 20 control points) on both sides of the subject in the levator scapulae muscles of individuals diagnosed with CNP.
The order of outcome measurements for each point was PPT, manual tension index sonoelastography and tensiomyography separated by 15 minutes. Objective contractile parameters were: contraction time (Tc), mean relaxation time (Tr), maximum radial displacement (Dm), holding time (Ts) and delay time (Td).
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Sonoelastography, tensiomyography and mechanosensitivity
- Keywords
- physiotherapies techniques, sonoelastography;, muscle tension, neck pain
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonoelastography, tensiomyography and mechanosensitivityDiagnostic test
To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Compression group | Experimental | IC group with conservative technique in trigger points in levator scapulae muscle Receives: Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivity |
| Dry needling group | Active comparator | Dry needling group with invasive technique in trigger points in levator scapulae muscle Receives: Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
manual tension index sonoelastography
Measurement of manual ultrasound transducer tension on the trigger point of the levator scapulae
Measured: 1 week
Secondary outcomes (2)
tensiomyography
Ultrasound transducer tensiomyography measurement of the levator scapulae trigger point
Measured: 1 week
minimum intensity of a stimulus that elicits the sensation of pain (pressure pain threshold).
patient-tolerable pain at the trigger point of the levator scapulae muscle measured by algometer.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Sep 2022
- Primary completion21 Sep 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776199
- Sponsor's protocol ID
- 03/23
- Status last verified
- May 2023
- First submitted
- 6 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Myburgh C, Lauridsen HH, Larsen AH, Hartvigsen J. Standardized manual palpation of myofascial trigger points in relation to neck/shoulder pain; the influence of clinical experience on inter-examiner reproducibility. Man Ther. 2011 Apr;16(2):136-40. doi: 10.1016/j.math.2010.08.002. Epub 2010 Sep 1.
PubMed 20813576Tous-Fajardo J, Moras G, Rodriguez-Jimenez S, Usach R, Doutres DM, Maffiuletti NA. Inter-rater reliability of muscle contractile property measurements using non-invasive tensiomyography. J Electromyogr Kinesiol. 2010 Aug;20(4):761-6. doi: 10.1016/j.jelekin.2010.02.008. Epub 2010 Mar 16.
PubMed 20236839Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics. 2017 Mar 7;7(5):1303-1329. doi: 10.7150/thno.18650. eCollection 2017.
PubMed 28435467Thomas K, Shankar H. Targeting myofascial taut bands by ultrasound. Curr Pain Headache Rep. 2013 Jul;17(7):349. doi: 10.1007/s11916-013-0349-4.
PubMed 23793988Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
PubMed 22506152Turo D, Otto P, Shah JP, Heimur J, Gebreab T, Zaazhoa M, Armstrong K, Gerber LH, Sikdar S. Ultrasonic characterization of the upper trapezius muscle in patients with chronic neck pain. Ultrason Imaging. 2013 Apr;35(2):173-87. doi: 10.1177/0161734612472408.
PubMed 23493615Koo TK, Guo JY, Brown CM. Test-retest reliability, repeatability, and sensitivity of an automated deformation-controlled indentation on pressure pain threshold measurement. J Manipulative Physiol Ther. 2013 Feb;36(2):84-90. doi: 10.1016/j.jmpt.2013.01.001.
PubMed 23499143
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonoelastography, Tensiomyography and Mechanosensitivity Between Latent, Active and Control Trigger Points in Myofascial Trigger Points of the Levator Scapulae Muscle.
- ClinicalTrials.gov ID
- NCT05776199
- Acronym / sponsor ID
- 03/23
- Conditions
- Myofascial Pain Syndrome
- Keywords
- physiotherapies techniques, sonoelastography;, muscle tension, neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 20 Mar 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.
Chronic neck pain (CNP) is considered one of the most common musculoskeletal disorders worldwide and myofascial pain syndrome (MPS) is the most prevalent musculoskeletal disorder in the majority of the population. However, normal tissue contractility changes and the different types of myofascial trigger points (MTrPs) measured by tensiomography have not yet been studied. For this reason, the aim of our study is to determine the differences in pressure pain threshold (PPT), tensiomyography and sonoelastography between the palpation zone of control points with respect to active and latent MTrPs in the levator scapulae muscles of subjects with CNP. A single-blind descriptive cross-sectional study is conducted with a convenience sample of 60 points (20 active, 20 latent and 20 control points) on both sides of the subject in the levator scapulae muscles of individuals diagnosed with CNP.
The order of outcome measurements for each point was PPT, manual tension index sonoelastography and tensiomyography separated by 15 minutes. Objective contractile parameters were: contraction time (Tc), mean relaxation time (Tr), maximum radial displacement (Dm), holding time (Ts) and delay time (Td).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Compression group | Experimental | Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivityIC group with conservative technique in trigger points in levator scapulae muscle |
| Dry needling group | Active comparator | Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivityDry needling group with invasive technique in trigger points in levator scapulae muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Bilateral presence of at least one active trigger point.
- One control point and one latent trigger point in the levator scapulae muscles.
- Subjects aged between 18 and 65 years.
- Subjects diagnosed with chronic neck pain for more than 6 weeks.
- Signed informed consent to be able to participate in the study.
Key exclusion criteria (9 listed)
- Previous treatment for chronic neck pain (within one year) or medical history with a diagnosis of neuropathy.
- Rheumatoid arthritis.
- Myopathy.
- Cognitive impairment or mental disability.
- Skin disorders.
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 |
|---|---|---|
| Sonoelastography, tensiomyography and mechanosensitivityTo observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options. | Diagnostic test | Dry needling group, Ischemic Compression group |
Primary outcome
manual tension index sonoelastography
Time frame: 1 week
Measurement of manual ultrasound transducer tension on the trigger point of the levator scapulae
2 secondary outcomes
tensiomyography
Time frame: 1 week
minimum intensity of a stimulus that elicits the sensation of pain (pressure pain threshold).
Time frame: 1 week
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 6 May 2023.
- Background: PubMed 20813576Myburgh C, Lauridsen HH, Larsen AH, Hartvigsen J. Standardized manual palpation of myofascial trigger points in relation to neck/shoulder pain; the influence of clinical experience on inter-examiner reproducibility. Man Ther. 2011 Apr;16(2):136-40. doi: 10.1016/j.math.2010.08.002. Epub 2010 Sep 1.
- Results publication: PubMed 20236839Tous-Fajardo J, Moras G, Rodriguez-Jimenez S, Usach R, Doutres DM, Maffiuletti NA. Inter-rater reliability of muscle contractile property measurements using non-invasive tensiomyography. J Electromyogr Kinesiol. 2010 Aug;20(4):761-6. doi: 10.1016/j.jelekin.2010.02.008. Epub 2010 Mar 16.
- Results publication: PubMed 28435467Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics. 2017 Mar 7;7(5):1303-1329. doi: 10.7150/thno.18650. eCollection 2017.
- Results publication: PubMed 23793988Thomas K, Shankar H. Targeting myofascial taut bands by ultrasound. Curr Pain Headache Rep. 2013 Jul;17(7):349. doi: 10.1007/s11916-013-0349-4.
- Results publication: PubMed 22506152Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
- Results publication: PubMed 23493615Turo D, Otto P, Shah JP, Heimur J, Gebreab T, Zaazhoa M, Armstrong K, Gerber LH, Sikdar S. Ultrasonic characterization of the upper trapezius muscle in patients with chronic neck pain. Ultrason Imaging. 2013 Apr;35(2):173-87. doi: 10.1177/0161734612472408.
- Results publication: PubMed 23499143Koo TK, Guo JY, Brown CM. Test-retest reliability, repeatability, and sensitivity of an automated deformation-controlled indentation on pressure pain threshold measurement. J Manipulative Physiol Ther. 2013 Feb;36(2):84-90. doi: 10.1016/j.jmpt.2013.01.001.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonoelastography, tensiomyography and mechanosensitivity in people with Myofascial Pain Syndrome, run by Universidad Católica de Ávila at 1 site in Spain.
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 5 inclusion and 9 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 6 May 2023. 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 Spain. 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?
manual tension index sonoelastography (time frame: 1 week). 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 NCT05776199, which also lists 7 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 6 May 2023.