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NCT Number: NCT07139288

Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability

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?

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Key information

Conditions

Chronic Ankle Instability, CAI

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy Cairo University

Giza, EL Dokki, Egypt

Location contact

Dina Ramadan Ahmed, Doctoral

PRINCIPAL_INVESTIGATOR

About this study

The purpose of the study will be to investigate the effect of extracorporeal shock wave versus photobiomodulation therapy for chronic ankle instability Design of the study: A pre and posttest randomized controlled trial.

Subjects of the study:

participants will be chosen according to inclusive criteria. The sample size will be calculated depending on pilot study by power analysis (G power).

Group A: will receive exercise program include (Resistance Band Protocols, Resistance Kinematic Chain Exercises, Heel raise and Balance Exercise) at painful ankle.

Group B: as group A, plus the extra corporeal shock wave. Group C: as group A, plus the photobiomodulation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 participants ranging in age from 18 to 65 years from both gender with a diagnosis of Chronic lateral ankle instability stage (II) (Schurz et al., 2023).

Patients body mass index (BMI) are ranged from 18,5 to 25 (lee et al., 2022). The main presenting symptoms were ankle pain with restricted ROM that compromised activities of daily living (Schurz et al., 2023).

All ankle sprains occurring more than four weeks before inclusion both recurrent sprain and CAI patients are included (Schurz et al., 2023).

Mild to moderate severity of pain measured by NPRS scale (Srinivas, 2022). no wounds in the ankle joint and calf (lee et al., 2022). Participants had no history of ankle joint injuries or surgical procedures within the last year and injection treatment around the ankle joint within six months (lee et al., 2022).

Exclusion criteria

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

Any individual who had previously suffered a musculoskeletal injury or surgery that could have influenced the measurement was also eliminated.

Any individual who had diagnosed a Chronic lateral ankle instability stage (I, III).

Acute foot trauma occurring from 7 days of injury (Srinivas, 2022).

Treatment and study plan

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

Other names: balance and strength training

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

Other names: PBM

Primary outcomes

  1. Thickness of ligament in patients with chronic ankle instability.

    Time frame: Before and after treatment program for 1 month

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

  2. Function activity level

    Time frame: Before and after treatment program for 1 month

    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

Secondary outcomes

  1. pain assessment:

    Time frame: Before and after treatment program for 1 month

    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

  2. Ankle joint range of motion

    Time frame: Before and after treatment program for 1 month

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Ramadan Ahmed, Doctoral

CONTACT

[email protected]

02+ 01033302828

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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