Clinical trial NCT05916300: Diagnostic Ultrasonography in Physiotherapy
Official title: Diagnostic Ultrasonography in Physiotherapy as a Prevention of the Development of Complications of Post-Traumatic Ankle Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Sprains
Ankle Injuries
Ankle Edema
Ankle Impingement
Ankle Fractures
Keywords: Diagnostic ultrasonography
physiotherapy
post-traumatic ankle conditions
prevention
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute post-traumatic ankle conditions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain level
timeFrame: The change from baseline to 8 weeks
measure: The range of motion of the ankle
timeFrame: The change from baseline to 8 weeks
measure: The measurement of swelling
timeFrame: The change from baseline to 8 weeks
measure: Number of complications
timeFrame: The change from baseline to 8 weeks
Secondary outcomes:
measure: Chronic ankle instability rate
timeFrame: The change from baseline to 8 weeks
measure: Analysis of standing and walking
timeFrame: The change from baseline to 8 weeks
measure: Examination of ankle dorsiflexion muscle strength
timeFrame: The change from baseline to 8 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Alafia-RHB
Study officials:
affiliation: Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague
name: Petr Routner, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Medicine, Third Faculty of Medicine, Charles University in Prague
name: Kamila Řasová, PT, PhD.
role: STUDY_DIRECTOR
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