Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability

NCT ID: NCT07139288

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2026-01-10

Brief Summary

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?

Detailed Description

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

Conditions

Chronic Ankle Instability, CAI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Exercise Program

articipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed.

Group Type: ACTIVE_COMPARATOR

therapeutic exercise program

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

ESWT

participants will receive Extracorporeal Shock Wave Therapy (ESWT) in addition to standard care.

Group Type: EXPERIMENTAL

Extra corporeal shock wave therapy

Intervention Type: 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

Participants receive photobiomodulation therapy (low-level laser/LED) in addition to standard care.

Group Type: EXPERIMENTAL

photobiomodulation Therapy

Intervention Type: 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

Interventions

therapeutic exercise program

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

Intervention Type: BEHAVIORAL

Extra corporeal shock wave therapy

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

Intervention Type: DEVICE

photobiomodulation Therapy

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

Intervention Type: DEVICE

Other Intervention Names

balance and strength training; PBM

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Ramadan Ahmed

Assistant lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy Cairo University

Giza, EL Dokki, Egypt

Countries

Egypt

Central Contacts

Dina Ramadan Ahmed, Doctoral

Role: CONTACT

dinaramadan2431993@gmail.com

02+ 01033302828

Other Identifiers

P.T.REC/012/005760

Identifier Type: -

Identifier Source: org_study_id