NCT05782439

Brief Summary

The goal of this clinical-test study is to evaluate the reliability of the direct palpation of the ileotibial band. For this purpose, a group of 100 healthy subjects will be considered. The main question it aims to answer regards the reproducibility of the intra and inter examiner evaluation performed on the same day (intra-day) and the validation of the palpatory examination with an instrumental measure of the tissue tension. Participants will undergo a manual and instrumental sampling of the ileotibial band tension of both legs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable healthy

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

November 25, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

March 23, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 16, 2023

Last Update Submit

March 13, 2023

Conditions

Keywords

ileotibial bandclinical-testdirect palpation

Outcome Measures

Primary Outcomes (1)

  • Precision of the palpation test

    intra-day concordance intra and inter examiners by means of weighted Cohen's K with use of sampling evaluation divided into 3 intervals (+1, 0, -1) and 7 intervals (+3, +2, +1, 0, -1, -2, -3)

    5 seconds for each evaluation (day 1)

Secondary Outcomes (2)

  • Effect of training

    5 seconds for each evaluation (day 1)

  • Accuracy of the palpation test

    5 seconds for each evaluation (day 1)

Study Arms (1)

Healthy adults

EXPERIMENTAL

Manual and instrumental evaluation to identify if there is an equal or different stiffness between the right and left ileotibial band.

Other: Manual evaluation of ITB tension

Interventions

There will be a double evaluation for each sampling session: 1) if there is a uniformity of the tension between the two sides, or if there is a prevalence on one side; 2) quantification of the difference, if present, with a graduation in 3 levels.

Healthy adults

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- healthy subjects

You may not qualify if:

  • clinically evident painful symptoms that, in the opinion of the subject himself or the examiner, may prevent the test from being carried out (for example, pain in the hip while maintaining the sampling position);
  • evident excess weight (BMI greater than 28 kg / m2) which may make the manual and instrumental result obtained doubtful.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center

Bologna, 40128, Italy

Location

Related Publications (7)

  • Arab AM, Nourbakhsh MR. The relationship between hip abductor muscle strength and iliotibial band tightness in individuals with low back pain. Chiropr Osteopat. 2010 Jan 13;18:1. doi: 10.1186/1746-1340-18-1.

    PMID: 20157442BACKGROUND
  • Chen G, Wu J, Chen G, Lu Y, Ren W, Xu W, Xu X, Wu Z, Guan Y, Zheng Y, Qiu B. Reliability of a portable device for quantifying tone and stiffness of quadriceps femoris and patellar tendon at different knee flexion angles. PLoS One. 2019 Jul 31;14(7):e0220521. doi: 10.1371/journal.pone.0220521. eCollection 2019.

    PMID: 31365582BACKGROUND
  • Cibulka MT, Bennett J. How weakness of the tensor fascia lata and gluteus maximus may contribute to ACL injury: A new theory. Physiother Theory Pract. 2020 Mar;36(3):359-364. doi: 10.1080/09593985.2018.1486492. Epub 2018 Jun 21.

    PMID: 29927670BACKGROUND
  • Friede MC, Klauser A, Fink C, Csapo R. Stiffness of the iliotibial band and associated muscles in runner's knee: Assessing the effects of physiotherapy through ultrasound shear wave elastography. Phys Ther Sport. 2020 Sep;45:126-134. doi: 10.1016/j.ptsp.2020.06.015. Epub 2020 Jul 25.

    PMID: 32769015BACKGROUND
  • Patijn, J. Reproducibility protocol for diagnostic procedures in Manual/Musculoskeletal Medicine. Manuelle Medizin 2019; 57, 451-479.

    BACKGROUND
  • Melchione WE, Sullivan MS. Reliability of measurements obtained by use of an instrument designed to indirectly measure iliotibial band length. J Orthop Sports Phys Ther. 1993 Sep;18(3):511-5. doi: 10.2519/jospt.1993.18.3.511.

    PMID: 8298633BACKGROUND
  • Garcia-Bernal MI, Heredia-Rizo AM, Gonzalez-Garcia P, Cortes-Vega MD, Casuso-Holgado MJ. Validity and reliability of myotonometry for assessing muscle viscoelastic properties in patients with stroke: a systematic review and meta-analysis. Sci Rep. 2021 Mar 3;11(1):5062. doi: 10.1038/s41598-021-84656-1.

    PMID: 33658623BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Three different group (40, 20 and 40 subjects respectively) are enrolled in sequence and undergo the same evaluation procedure.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 23, 2023

Study Start

November 25, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 23, 2023

Record last verified: 2023-02

Locations