Diagnostic Ultrasonography in Physiotherapy

NCT05916300 | Unknown

• 1 other identifier: 81512267
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Ankle injuries are among the most common traumatological injuries of the lower limb accounting for approximately 50% of all sports injuries and 25% of musculoskeletal injuries in general. Correct initial diagnosis and proper management is important to reduce the risk of recurrent ankle instability and other complications, such as reduced range of motion, increased ligament laxity, instability, tendon enthesopathy, possible swelling, formation of calcifications, reduced load on the affected limbs while standing and walking, increased pain intensity and pain duration. To date, few studies showed that the effectiveness of physical therapy increases when it is modified based on diagnostic ultrasonography findings. Sonography is not burdensome for the patient, has high reproducibility, and enables dynamic examination and comparison of the interrelationships of individual structures. The aim of this study is to investigate if targeted physiotherapy for post-traumatic ankle conditions designed based of diagnostic ultrasonography findings is more effective than standard physiotherapy. The study hypothesis is that in the experimental group there will be a smaller number of complications of post-traumatic ankle conditions than in the control group. If confirmed the study could have clinical implications.

Conditions

Ankle Sprains; Ankle Injuries; Ankle Edema; Ankle Impingement; Ankle Fractures

Keywords

Diagnostic ultrasonography; physiotherapy; post-traumatic ankle conditions; prevention

Outcome Measures

Primary Outcomes (4)

• Pain level

  Examination using the Wong-Baker scale. The scale is used to subjectively assess pain. Pain rating scale (0-10): 0 - no pain; 2 - hurts a little; 4 - hurts a little more; 6 - hurts even more; 8 - hurts a lot; 10 - hurts the most (0 is the best value, 10 is the worst).

  The change from baseline to 8 weeks

• The range of motion of the ankle

  Goniometry will be performed with a stainless steel two-arm goniometer (ref. SH5103). Measurement of the ankle (talocrural joint) dorsiflexion range of motion: Participants will actively adduct the tip of the injured ankle while sitting on a physical therapy table. The expected range of motion with knee extension is approx. 10 degrees, with 20 degrees of knee flexion. For the evaluation, we will use a 3-point evaluation scale: 0-3 (0 - no limitation in dorsiflexion, 1 - small limitation in dorsiflexion, 2 - great limitation in dorsiflexion, 3 - no movement in dorsiflexion) (0 means the best value, 3 is the worst).

  The change from baseline to 8 weeks

• The measurement of swelling

  Over the course of the therapy, we will measure the swelling with a standard retractable four-inch plastic tape measure and a marking pen according to a standardized protocol. (decreasing the size of edema over time marks positive change).

  The change from baseline to 8 weeks

• Number of complications

  The following complications will be monitored using sonographic examination based on a standardized protocol issued by the European Society of Musculoskeletal Radiology using a 7L4BP 5-10 MHz linear probe. The following complications will be measured according to standardized methodologies and evaluated by comparison with the same measured parameters on the ankle of the uninjured leg: 1. greater thickness of the ligaments (anterior tibiofibular and anterior talofibular ligament); 2. the presence of exudate in the area of anterior talofibular ligament, 3. the presence of calcifications, 4. a reduction in the continuity of the ligament apparatus in the ankle or the continuity of the syndesmosis compared to the non-affected leg. A higher number means a higher number of complications.

  The change from baseline to 8 weeks

Secondary Outcomes (3)

• Chronic ankle instability rate

  The change from baseline to 8 weeks

• Analysis of standing and walking

  The change from baseline to 8 weeks

• Examination of ankle dorsiflexion muscle strength

  The change from baseline to 8 weeks

Study Arms (2)

Standard physiotherapy group

Patients will be treated with standard physiotherapy according to the recommendation of the referring physician without modification of the treatment based on the output of the diagnostic ultrasonography examination.

Other: Diagnostic ultrasonography-guided physiotherapy group

Diagnostic ultrasonography-guided physiotherapy group

Patients will undergo modified treatment techniques, the application of which will be indicated based on the initial diagnostic ultrasonographic examination.

Other: Diagnostic ultrasonography-guided physiotherapy group

Interventions

Diagnostic ultrasonography-guided physiotherapy group OTHER

All participants will complete free 10 outpatient 30-minute sessions. The therapy will be focused on increasing the range of motion and muscle strength, optimizing the function of the lower limbs, reducing possible complications of post-traumatic conditions in the ankle area. The physiotherapy procedures of the intervention group will be modified based on the initial diagnostic ultrasonography examination.

Diagnostic ultrasonography-guided physiotherapy group; Standard physiotherapy group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute post-traumatic ankle conditions

You may qualify if:

• Age ≥ 15 years and ≤ 65 years
• Post-traumatic conditions in the ankle area, 0 - 6 weeks after the primary injury
• Ability to undergo continuous outpatient physiotherapy treatment
• Active cooperation of the patient

You may not qualify if:

• Age \< 15 years and \> 65 years
• Serious diseases affecting effective physiotherapy (e.g. tissue damage of metabolic, degenerative, neurological or oncological origin)
• Previous ankle surgery
• Gypsum fixation

Sponsors & Collaborators

• Petr Routner: lead

Study Sites (1)

Alafia-RHB

Prague, 19800, Czechia

RECRUITING

Related Publications (21)

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  PMID: 17513688 BACKGROUND

• Bergman R, Shuman VL. Acute Ankle Sprain. 2025 Aug 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459212/

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• Martin B. Ankle sprain complications: MRI evaluation. Clin Podiatr Med Surg. 2008 Apr;25(2):203-47, vi. doi: 10.1016/j.cpm.2007.12.004.

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• Sconfienza LM, Adriaensen M, Albano D, Alcala-Galiano A, Allen G, Aparisi Gomez MP, Aringhieri G, Bazzocchi A, Beggs I, Chianca V, Corazza A, Dalili D, De Dea M, Del Cura JL, Di Pietto F, Drakonaki E, Facal de Castro F, Filippiadis D, Gitto S, Grainger AJ, Greenwood S, Gupta H, Isaac A, Ivanoski S, Khanna M, Klauser A, Mansour R, Martin S, Mascarenhas V, Mauri G, McCarthy C, McKean D, McNally E, Melaki K, Messina C, Miron Mombiela R, Moutinho R, Olchowy C, Orlandi D, Prada Gonzalez R, Prakash M, Posadzy M, Rutkauskas S, Snoj Z, Tagliafico AS, Talaska A, Tomas X, Vasilevska Nikodinovska V, Vucetic J, Wilson D, Zaottini F, Zappia M, Obradov M. Clinical indications for image-guided interventional procedures in the musculoskeletal system: a Delphi-based consensus paper from the European Society of Musculoskeletal Radiology (ESSR)-part VI, foot and ankle. Eur Radiol. 2022 Feb;32(2):1384-1394. doi: 10.1007/s00330-021-08125-z. Epub 2021 Aug 25.

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• PAZ, JC, QUINLAN, D. Acute Pain Management. Acute Care Handbook for Physical Therapists-E-Book. 2013; 7: 457-465.

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• WATSON CP, BOLAND RA., REFSHAUGE KM. Measurement reliability of swelling in the acute ankle sprain. The Foot & Ankle Journal. 2008; 1(12): 4.

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• Esterson PS. Measurement of ankle joint swelling using a figure of 8*. J Orthop Sports Phys Ther. 1979;1(1):51-2. doi: 10.2519/jospt.1979.1.1.51.

  PMID: 18810189 BACKGROUND

• Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.

  PMID: 16935061 BACKGROUND

• Sisto SA, Dyson-Hudson T. Dynamometry testing in spinal cord injury. J Rehabil Res Dev. 2007;44(1):123-36. doi: 10.1682/jrrd.2005.11.0172.

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• Yin Y, Yu Z, Wang J, Sun J. Effectiveness of the Rehabilitation Training Combined with Maitland Mobilization for the Treatment of Chronic Ankle Instability: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Nov 20;19(22):15328. doi: 10.3390/ijerph192215328.

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• MCNALLY, E. Practical musculoskeletal ultrasound E-Book [online]. 2nd Edition. Churchill Livingstone, 2014. ISBN 978-1-4557-7404-3.

  BACKGROUND

• SCHMITZ, Marc J.H. Musculoskeletal ultrasound of the extremity joints : technical scanning guidelines [online]. SonoSkills, 2022. ISBN 9083240304.

  BACKGROUND

• BEGGS, Ian, STEFANO BIANCHI, ANGEL BUENO, MICHEL COHEN, MICHEL COURT-PAYEN, ANDREW GRAINGER, FRANZ KAINBERGER, ANDREA KLAUSER, CARLO MARTINOLI, EUGENE MCNALLY, J PHILIPO, PHILIPPE PEETRONS, MONIQUE REIJNIERSE. European Society of MusculoSkeletal Radiology Musculoskeletal Ultrasound Technical Guidelines VI. Ankle [online]. 2016 [cit. 2023-03-08]. Available at: https://essr.org/content-essr/uploads/2016/10/ankle.pdf

  BACKGROUND

• Petersen EJ, Irish SM, Lyons CL, Miklaski SF, Bryan JM, Henderson NE, Masullo LN. Reliability of water volumetry and the figure of eight method on subjects with ankle joint swelling. J Orthop Sports Phys Ther. 1999 Oct;29(10):609-15. doi: 10.2519/jospt.1999.29.10.609.

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• Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.

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• R CORE TEAM. R Core Team 2021 R: A language and environment for statistical computing. R foundation for statistical computing. https://www.R-project.org/. R Foundation for Statistical Computing [online]. 2022, 2, 2019 [cit. 2023-01-30]. Available at: https://www.scirp.org/(S(czeh2tfqw2orz553k1w0r45))/reference/referencespapers.aspx?referenceid=3131254

  BACKGROUND

• De Maeseneer M, Marcelis S, Jager T, Shahabpour M, Van Roy P, Weaver J, Jacobson JA. Sonography of the normal ankle: a target approach using skeletal reference points. AJR Am J Roentgenol. 2009 Feb;192(2):487-95. doi: 10.2214/AJR.08.1316.

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Related Links

• Goniometry: Ankle (Talocrural) Dorsiflexion - Physiopedia
• CORE MEASURE: 10 METER WALK TEST (10mWT)
• Gait Range of Motion Animation
• microFET2 User Guide

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Petr Routner, MSc.

  Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague

  PRINCIPAL INVESTIGATOR

• Kamila Řasová, PT, PhD.

  Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague

  STUDY DIRECTOR

Central Study Contacts

Petr Routner, MSc.

CONTACT

+420602393203; routa2005@seznam.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: June 23, 2023
• Study Start: September 18, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be made available from 3-months following the first publication of findings based on the data until 3 years following the first publication.
• Access Criteria: The datasets will be prepared and might be reachable upon a request. The study team formally reviews access requests for proposals. The data on an exclusive basis will be made available for third party use/ the new user, which can range from direct provision of data, data analysis collaboration, and/or scientific collaboration. Also, the requester is to state the purpose for which the data are to be used.

Locations

CZ (1)