Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability

NCT07139288 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005760
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Ankle Instability, CAI

Keywords

extracorporeal shock wave, photobiomodulation, chronic ankle instability

Outcome Measures

Primary Outcomes (2)

• 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

  Before and after treatment program for 1 month

• 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

  Before and after treatment program for 1 month

Secondary Outcomes (2)

• pain assessment:

  Before and after treatment program for 1 month

• Ankle joint range of motion

  Before and after treatment program for 1 month

Study Arms (3)

Exercise Program

ACTIVE COMPARATOR

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

Behavioral: therapeutic exercise program; Device: Extra corporeal shock wave therapy; Device: photobiomodulation Therapy

ESWT

EXPERIMENTAL

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

Device: Extra corporeal shock wave therapy

Photobiomodulation

EXPERIMENTAL

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

Device: photobiomodulation Therapy

Interventions

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

Also known as: balance and strength training

Exercise Program

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

ESWT; Exercise Program

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

Also known as: PBM

Exercise Program; Photobiomodulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, EL Dokki, Egypt

Location

MeSH Terms

Interventions

Resistance Training; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Laser Therapy; Phototherapy

Central Study Contacts

Dina Ramadan Ahmed, Doctoral

CONTACT

02+ 01033302828; dinaramadan2431993@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture

Model Details: Inclusion criteria; The following criteria will be included: 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). Partici¬pants had no history of ankle joint injuries or surgical procedures within the last year and injection treatment around the ankle joint within six months

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: August 29, 2025
• Primary Completion: December 10, 2025
• Study Completion: January 10, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

EG (1)