Diagnostic Ultrasonography in Physiotherapy

Recruiting

• Conditions: Ankle Injuries; Ankle Edema; Ankle Sprains; Ankle Impingement; Ankle Fractures
• Interventions: Other: Diagnostic ultrasonography-guided physiotherapy group

• Registration Number: NCT05916300
• Lead Sponsor: Petr Routner

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.

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 Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Status Verified: 2023-09
• Study Start: 2023-09-18
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard physiotherapy group	Diagnostic ultrasonography-guided 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.
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.

Primary Outcome Measures

Name	Time	Method
The measurement of swelling	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).
Pain level	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 range of motion of the ankle	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).
Number of complications	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.

Secondary Outcome Measures

Name	Time	Method
Chronic ankle instability rate	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.
Analysis of standing and walking	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).
Examination of ankle dorsiflexion muscle strength	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.

Trial Locations

Locations (1)

Alafia-RHB; 🇨🇿 Prague, Czechia