Chronic Ankle Instability, CAINCT07139288
Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability
A study testing therapeutic exercise program, Extra corporeal shock wave therapy and photobiomodulation Therapy in people with Chronic Ankle Instability, CAI, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Ankle Instability, CAI
- What is being tested?
- therapeutic exercise program, Extra corporeal shock wave therapy and photobiomodulation Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy Cairo University
Giza, EL Dokki
Dina Ramadan Ahmed, Doctoral
About this study
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.
Read more
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?
Read the 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
- Being tested
- therapeutic exercise program, Extra corporeal shock wave therapy, photobiomodulation Therapy
- Keywords
- extracorporeal shock wave, photobiomodulation, chronic ankle instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercise programBehavioural
Also called balance and strength training
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 therapyDevice
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 TherapyDevice
Also called PBM
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Active comparator | articipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed. Receives: 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. Receives: Device: Extra corporeal shock wave therapy |
| Photobiomodulation | Experimental | Participants receive photobiomodulation therapy (low-level laser/LED) in addition to standard care. Receives: Device: photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Before and after treatment program for 1 month
Secondary outcomes (2)
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
Measured: Before and after treatment program for 1 month
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
Measured: Before and after treatment program for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start29 Aug 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ramadan Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139288
- Sponsor's protocol ID
- P.T.REC/012/005760
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT07139288
- Acronym / sponsor ID
- P.T.REC/012/005760
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- extracorporeal shock wave, photobiomodulation, chronic ankle instability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Aug 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Active comparator | Behavioral: therapeutic exercise program, Device: Extra corporeal shock wave therapy, Device: photobiomodulation Therapyarticipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed. |
| ESWT | Experimental | Device: Extra corporeal shock wave therapyparticipants will receive Extracorporeal Shock Wave Therapy (ESWT) in addition to standard care. |
| Photobiomodulation | Experimental | Device: photobiomodulation TherapyParticipants receive photobiomodulation therapy (low-level laser/LED) in addition to standard care. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic exercise programAlso: balance and strength trainingEach 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 | Behavioural | Exercise Program |
| Extra corporeal shock wave therapyThe 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 | Device | ESWT, Exercise Program |
| photobiomodulation TherapyAlso: PBMPhotobiomodulation 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 | Device | Exercise Program, Photobiomodulation |
Primary outcome
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
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
2 secondary outcomes
pain assessment:
Time frame: Before and after treatment program for 1 month
Ankle joint range of motion
Time frame: Before and after treatment program for 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercise program, Extra corporeal shock wave therapy and photobiomodulation Therapy in people with Chronic Ankle Instability, CAI, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Ramadan Ahmed, Doctoral (02+ 01033302828, dinaramadan2431993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of ligament in patients with chronic ankle instability. (time frame: Before and after treatment program for 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.