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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05776199
Other study ID # 03/23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 28, 2022

Study information

Verified date May 2023
Source Universidad Católica de Ávila
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 28, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Sonoelastography, tensiomyography and mechanosensitivity
To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.

Locations

Country Name City State
Spain Universidad Católica de Ávila Ávila

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.jeleki — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary manual tension index sonoelastography Measurement of manual ultrasound transducer tension on the trigger point of the levator scapulae 1 week
Secondary tensiomyography Ultrasound transducer tensiomyography measurement of the levator scapulae trigger point 1 week
Secondary 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. 1 week
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