NCT05776199

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

20 days

First QC Date

March 6, 2023

Last Update Submit

May 3, 2023

Conditions

Keywords

physiotherapies techniquessonoelastography;muscle tensionneck pain

Outcome Measures

Primary Outcomes (1)

  • manual tension index sonoelastography

    Measurement of manual ultrasound transducer tension on the trigger point of the levator scapulae

    1 week

Secondary Outcomes (2)

  • tensiomyography

    1 week

  • minimum intensity of a stimulus that elicits the sensation of pain (pressure pain threshold).

    1 week

Study Arms (2)

Ischemic Compression group

EXPERIMENTAL

IC group with conservative technique in trigger points in levator scapulae muscle

Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivity

Dry needling group

ACTIVE COMPARATOR

Dry needling group with invasive technique in trigger points in levator scapulae muscle

Diagnostic Test: Sonoelastography, tensiomyography and mechanosensitivity

Interventions

To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.

Dry needling groupIschemic Compression group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (7)

  • 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.

    PMID: 20813576BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 20, 2023

Study Start

September 1, 2022

Primary Completion

September 21, 2022

Study Completion

December 28, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations