Diagnostic Ultrasonography in Physiotherapy (SonograPHY)

September 19, 2023 updated by: Petr Routner

Diagnostic Ultrasonography in Physiotherapy as a Prevention of the Development of Complications of Post-Traumatic Ankle Conditions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial

In a randomized controlled trial, patients with post-traumatic soft tissue damage in the ankle area will be randomly divided into two groups. Both groups will undergo the same number of physiotherapy sessions (10 half-hour outpatient sessions over the course of two months) and will be examined with standard clinical tests and diagnostic ultrasonography at the beginning of the program and at week 8 using a standardized protocol published by the European Society of Musculoskeletal Radiology. Both groups will undergo the same physiotherapy techniques. Their choice will be modified in the experimental group based on the current findings of diagnostic sonography, while in the control group they will be applied according to the standard procedure recommended by the physician.

Randomization

Participants meeting the entry criteria will be examined by diagnostic ultrasonography, then randomly assigned to two groups using software (https://www.randomizer.org/) and sent for an entry examination by an independent investigator. Group 1 will undergo standard physiotherapy without continuous monitoring of the course and effect of treatment with diagnostic ultrasonography. The treatment of the second group will be modified based on the current findings of the diagnostic ultrasonography. The therapeutic protocol for each patient will be given to an independent physiotherapist (the therapist will not know the details of the study) in a sealed envelope.

Study participants

Study participants will be recruited based on referrals from specialists (mainly orthopaedists or surgeons) following the entry and exclusion criteria below. When a patient meeting the criteria is detected, the specialist will offer the patient the opportunity to participate in the study, and if agreed, the patient will be sent to our workplace for an initial examination.

Sample size

A sample size of 26 patients per group (N=52) was estimated to test the difference in pain (primary outcome, scale 0-10; at 80% test power (Cohen´s d=0.8) and at the 0.05 significance level) between the intervention and control groups. We estimate that 15% of participants will not complete the study, therefore 68 patients will be enrolled in the study (34 patients in each group).

Basic statistical analysis of outcome variables

Difference in numeric variables (pain, chronic ankle instability rate, the 10 Metre Walk Test, examination of ankle dorsiflexion muscle strength) between the intervention and control groups will be tested using the two-sample t-test or Mann-Whitney Test, if normality of the data was not fulfilled. Data normality will be assessed using the Shapiro-Wilk test and visually using box and whisker plots, histograms and normal probability plots. Difference in categorical variables (the range of motion of the ankle, the presence of swelling, number of complications) will be tested using chi-square test or Fisher's exact test, if at least one expected frequency will be smaller than 5. R software will be used for analysis.

Examination

Demographic, anthropometric and anamnestic data of all participants will be recorded at the beginning of the programme (age, sex, height, weight, exercise history, injury history, including frequency of past injuries, footwear). The clinical examination will be carried out at the beginning and at the end of the therapeutic program, i.e. after two months from the start of the program.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with acute post-traumatic ankle conditions

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: The change from baseline to 8 weeks
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
Time Frame: The change from baseline to 8 weeks

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
Time Frame: The change from baseline to 8 weeks
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
Time Frame: The change from baseline to 8 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic ankle instability rate
Time Frame: The change from baseline to 8 weeks
The Cumberland Ankle Instability Tool (CAIT) is a simple, valid and reliable instrument for discriminating and measuring the severity of functional ankle instability. The CAIT comprises a 9-item 30-point scale questionnaire (the higher final score indicates less severe functional ankle instability). Subjects with a score of 28 or higher are unlikely to have functional ankle instability, whereas subjects with a score of 27 or lower are likely to have functional ankle instability.
The change from baseline to 8 weeks
Analysis of standing and walking
Time Frame: The change from baseline to 8 weeks
The 10 Metre Walk Test. We will measure the gait speed, using a stopwatch and markers, a phone with a camera (the lower value means better result).
The change from baseline to 8 weeks
Examination of ankle dorsiflexion muscle strength
Time Frame: The change from baseline to 8 weeks

The examination will be held using a microFET2 hand-held digital dynamometer (Hoggan Scientific, USA).

The examination will be held according to a standardized protocol: Subjects will lie supine with the knee extended and ankle of the tested leg in a neutral position on the bed. Ankle dorsiflexion will be tested by placing a dynamometer over the dorsal surface of the midfoot, just proximal to the metatarsal phalangeal joints. We will measure the isometric muscle strength (in N) when the patient tries for maximum resistance against the dynamometer of the affected ankle for four seconds. A higher value of muscle strength after rehabilitation means an improvement of the condition.
The change from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petr Routner

Investigators

  • Principal Investigator: Petr Routner, MSc., Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague
  • Study Director: Kamila Řasová, PT, PhD., Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81512267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data sharing terms and conditions and the nature of the relationship between the study and new user will be contained in a Data-sharing Agreement that will be issued and signed before any data are handed out. The de-identification process for each patient is to ensure anonymization of individual patient's data, in order to be able to share IPD within the terms of participant's consent and ethics committee approval.

The study policy on sharing defines the terms of privileged use by the study team. The research team requires to be appropriately notified and acknowledged in publications and other outputs of the transferred data (or analyses conducted by the study on the new users' behalf). The Data-sharing agreement will comprehend arrangements for data destruction or secure archiving.

It is planned that the data will be placed into an online repository (to be specified later).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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