- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776199
Myofascial Trigger Points of the Levator Scapulae Muscle
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ávila, Spain, 05005
- Universidad Católica de Ávila
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Activity level of a high-level athlete.
- Medical conditions (fractures, structural deformities and neoplasms).
- Surgical interventions in the cervical-dorsal region or upper extremities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ischemic Compression group
IC group with conservative technique in trigger points in levator scapulae muscle
|
To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.
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Active Comparator: Dry needling group
Dry needling group with invasive technique in trigger points in levator scapulae muscle
|
To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
manual tension index sonoelastography
Time Frame: 1 week
|
Measurement of manual ultrasound transducer tension on the trigger point of the levator scapulae
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tensiomyography
Time Frame: 1 week
|
Ultrasound transducer tensiomyography measurement of the levator scapulae trigger point
|
1 week
|
minimum intensity of a stimulus that elicits the sensation of pain (pressure pain threshold).
Time Frame: 1 week
|
patient-tolerable pain at the trigger point of the levator scapulae muscle measured by algometer.
|
1 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tous-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.
- Turo 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.
- 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.
- Sigrist 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.
- Thomas 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.
- Park 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.
- Koo 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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