Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorCairo University

About this trial

PURPOSE:

To Compare between the effect of extra corporeal shock wave and Photobiomodulation on pain level, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability.

BACKGROUND:

Lateral ankle sprains are the most common lower limb musculoskeletal injury incurred by individuals who participate in sports and recreational physical activities Approximately 40% of individuals who sustain a LAS develop a condition known as chronic ankle instability (CAI) (Miklovic et al., 2018), The lateral ligamentous complex is the main structure affected in 80-85% of these injuries, which are originated from a sudden inversion or supination trauma (Mansur et al., 2021).

The ligament system plays a fundamental role in the ankle's stability and includes a talocrural complex and a subtalar complex that are functionally related. For the talocrural joint, three lateral collateral ligaments are present and one medial collateral ligament (Bonnel et al., 2010).

Physical examination is mostly the first diagnostic step in the assessment of ankle injuries. Imaging modalities such as ultrasonography (US) and magnetic resonance imaging (MRI) play a major role in providing a detailed depiction of ankle tendons and ligaments (Hosseinian et al., 2022).

The effect of ESWT is Higher multiplication of collagen fibers; faster organization of muscle fibers and vascularization by treatment with radial shockwaves (Schnurrer-Luke-Vrbanic et al., 2018), ESWT could improve pain, ankle instability, ankle function, dorsiflexion ROM, and dynamic balance in patients with CAI (Le et al., 2022).

Photobiomodulation Therapy (PBMT) is effective for patients with an ankle sprain. PBMT showed high effect size with a moderate level of evidence on pain intensity and is related to the PBMT intensity and frequency (Alayat et al., 2024).

HYPOTHESES:

There is no statistically significant effect of extra corporeal shock wave versus photobiomodulation on level of pain, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability.

RESEARCH QUESTION:

Is there any effect of extra corporeal shock wave versus Photobiomodulation on pain level, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

they had any medical condition that could cause ankle pain (arthritis, fracture, rheumatiod arthritis, any deformity of ankle and neurological condition).

Trial design

Design model

Crossover

Treatments tested in this trial

  • therapeutic exercise program

    Behavioral

    Each subject completes four dynamic tasks, including ankle resistance exercises, resistance kinematic chain exercises, heel raise exercises, and BOSU ball exercises at 3 times per week for 4 weeks

  • Extra corporeal shock wave therapy

    Device

    The extracorporeal shock waves will be delivered with 2,500 shockwave impulses (6 Hz), The intensity of extracorporeal shock waves is adjusted according to the patients' degree of tolerance to the pain. In the experimental group, the extracorporeal shockwave will apply to the anterior talofibular ligament, posterior talofibular ligament, calcaneofibular ligament, and tibialis anterior muscle. twice per week for 4 weeks

  • photobiomodulation Therapy

    Device

    Photobiomodulation therapy will be performed with a laser an 810 nm wavelength, 0 \~ 500 mW adjustable and continuous power output, and a 0.4 cm beam diameter was used. The subjects in the group C will be treated with the laser at a dose of 239 J/cm2 (power: 100 mW; intensity: 796 mW/cm2; irradiation time: 5 min/point, 20 min in total) at 3 times per week for 4 weeks

Treatment groups

38 Participants
are divided into 3 treatment groups
Group A: Exercise ProgramActive comparator 3 interventions
Group B: ESWTExperimental treatment 1 intervention
Group C: PhotobiomodulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Thickness of ligament in patients with chronic ankle instability.

Thickness of ligaments (lateral ligaments) measure by sonography that done according to European Society of Musculoskeletal Radiology (ESSR) guidelines by an experienced radiologist

Time frame
Before and after treatment program for 1 month
2

Function activity level

The Arabic version of the IdFAI (IdFAI-Ar) questionnaire is effectively translated and cross-culturally adapted. It is valid, reliable, accurate, specific, and sensitive tool to determine ankle stability status. It obtained excellent reliability and strong validity to identify patients with FAI in both clinical practice and research

Time frame
Before and after treatment program for 1 month

Secondary outcomes

1

pain assessment:

The Numeric Pain Rating Scale measures the magnitude or intensity of pain or pain relief. The NPRS is an 11-point scale consisting of integers from 0 through 10; 0 representing ''no pain'' and 10 representing ''worst imaginable Pain

Time frame
Before and after treatment program for 1 month
2

Ankle joint range of motion

The ROM will be measured using baseline bubble inclinometer which has been shown to have high intra examiner reliability and validity ankle dorsiflexion, planterflexion, inversion and eversion will be measured with the participant in the supine position

Time frame
Before and after treatment program for 1 month

Other outcomes

Sponsors and contacts

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