Chronic Ankle InstabilityNCT05500885
The Clinical Effectiveness of Pulsed Electromagnetic Field Therapy on the Management of Chronic Ankle Instability
A study testing PEMF device, Quantum Tx, Singapore in people with Chronic Ankle Instability, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of standard rehabilitation for the treatment of chronic ankle instability. The study objective is to establish whether PEMF plus standard rehabilitation in people with chronic ankle instability compared to standard… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- PEMF device, Quantum Tx, Singapore
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jan 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Requires a history of at least one significant sprain > 12 months prior to consent
- Continued perceived or episodic "giving way" of the ankle
- Reported Cumberland Ankle Instability Tool (CAIT score < 24)
Who cannot join
- A history of surgeries or fractures of either lower extremity limbs
- Concomitant lower extremity pathology, e.g. vascular disease and osteoarthritis
- Inadequate muscle strength in lower limb which require ambulation support (e.g., crutches) or any vestibular or balance disorders
- Pregnancy
- Cognitive impairment/Neurological conditions, and neurological disorders (e.g. dementia) -Concussion within the last 6 months
- Bilateral instability condition
Show all 10Show fewer
- Regular use of medicine or antibiotics
- Metal implantation in their body
- Unable to walk at enrolment
- Non-removable cast
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong, Hong Kong, New Territories
About this study
Official title: The Clinical Effectiveness of Pulsed Electromagnetic Field Therapy on the Management of Chronic Ankle Instability: A Double-Blinded Randomized Controlled Trial
This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of standard rehabilitation for the treatment of chronic ankle instability. The study objective is to establish whether PEMF plus standard rehabilitation in people with chronic ankle instability compared to standard rehabilitation. This study also investigates the effects of PEMF on pain, functional outcomes, and mechanical and morphological properties of peroneal muscles in chronic ankle instability. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties.
This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for chronic ankle instability. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital.
Read more
40 patients aged between 18 to 60 years old with CAI will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=20; PEMF (Quantum Tx) treatment), and the control group (n=20; sham treatment with dummy exposure to PEMF).
For Chronic Ankle Instability patients: baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as dynamic balance, static balance, single leg hop test, gait evaluation, dorsiflexion range of motion, and eversion muscle strength.
Read the detailed description
The primary objective is to investigate the effectiveness of PEMF therapy on the clinical and functional outcomes in the CAI population. We hypothesize that PEMF therapy will effectively improve the clinical and functional outcomes of patients with CAI.
Methods: This is a prospective, randomized, double-blinded, placebo-controlled trial with blinded assessors. A total of 40 adults with CAI will be recruited and randomly allocated into either the intervention or control group. In the intervention group, the participants (n=20) will receive active PEMF therapy and standard exercise training, while the control group (n=20) will receive sham-PEMF therapy and standard exercise training. The PEMF intervention will last for 8 weeks. The primary and secondary outcomes will be evaluated at baseline, week 4, week 8, 3rd month, 6th month after the PEMF therapy.
Rationale: Pulse electromagnetic field therapy (PEMF) as an adjunct biophysical therapy can improve stability by mitigating peroneal muscle weakness and activating peroneal muscle. Therefore, we postulate the combination of standard care (muscle strengthening, balance training, and range of motion exercise) augmented with pulse electromagnetic field therapy elicits a significant improvement in postural control stability and peroneal muscle weakness.
- Conditions
- Chronic Ankle Instability
- Being tested
- PEMF device, Quantum Tx, Singapore, Standard rehabilitation and sham PEMF therapy for CAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMF device, Quantum Tx, SingaporeDevice
The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.
Standard rehabilitation and sham PEMF therapy for CAIOther
Balance training and muscle strengthening
| Study group | Role | What they receive |
|---|---|---|
| Active PEMF therapy for chronic ankle instability | Experimental | Participants will be randomized into 1:1 allocation, blocked randomization with 20 participants in the PEMF group and 20 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. Receives: Device: PEMF device, Quantum Tx, Singapore |
| Sham PEMF therapy for chronic ankle instability | Sham comparator | Control group will receive sham treatment on top of a standard rehabilitation (muscle strengthening and balance training). Receives: Other: Standard rehabilitation and sham PEMF therapy for CAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centre of pressure during single leg stance for chronic ankle instability
Static balance will be conducted in double-leg and single leg stance with eyes opened and closed on the Tekscan pressure mat.
Measured: Baseline to 6 months
Secondary outcomes (11)
Y balance test for chronic ankle instability
Dynamic balance
Measured: Baseline to 6 months
Dorsiflexion Range of motion for chronic ankle instability
The range of motion (ROM) will be measured by weight bearing lunge test (WBLT).
Measured: Baseline to 6 months
Foot muscle strength for chronic ankle instability population
Foot muscle strength will be carried out using a handheld dynamometer during ankle dorsiflexion, plantar flexion, inversion and eversion.
Measured: Baseline to 6 months
Ultrasound imaging for peroneal muscle in chronic ankle instability patients
The ultrasound imaging assessment of the peroneal muscle will be performed using Aixplorer (Supersonic Imagine, Aix-en-Provence, France).
Measured: Baseline to 6 months
Short Form 36 questionnaire (SF-36)
The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: Baseline to 6 months
CAIT score
Cumberland Ankle Instability Tool (CAIT) score is a valid and reliable 9-item instrument used to identify self-perceived ankle instability. The instrument is scored on a 0 (worst) to 30 (best) scale, where a cut-off point of ≤ 24 denotes the presence of instability.
Measured: Baseline to 6 months
Lateral step-down test (LSDT)
LSDT is a clinical measurement that evaluates dynamic postural stability deficits and potential lower extremity injury. It measures the coordination of the lower limb joints, neuromuscular control, strength, pelvic stability, and range of motion.
Measured: Baseline to 6 months
The Manchester-Oxford Foot Questionnaire (MOxFQ)
It is validated 16-item, patient-reported outcome measure of foot and ankle pain and function
Measured: Baseline to 6 months
Numerical pain scale for chronic ankle instability
The numerical pain scale requires participants to rate their pain on a defined scale from 0-100. 0 refers to no pain while 100 refers to severe pain. Lower scores mean a better outcome.
Measured: Baseline to 6 months
Foot and ankle measure
Foot and Ankle Ability Measure (FAAM) will be used to assess the foot and ankle functional limitations among CAI individuals.
Measured: Baseline to 6 months
Dorsiflexion range of motion
Weight-bearing lung test (WBLT), based on the knee-to-wall principle, is a valid and reliable assessment that measures the dorsiflexion range of motion in CAI population.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start2 Jan 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500885
- Sponsor's protocol ID
- 2022.263-T
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chia CSM, Fu SC, He X, Cheng YY, Franco-Obregon A, Hua Y, Yung PS, Ling SK. The clinical effects of pulsed electromagnetic field therapy for the management of chronic ankle instability: a study protocol for a double-blind randomized controlled trial. Trials. 2024 Dec 3;25(1):808. doi: 10.1186/s13063-024-08639-z.
PubMed 39627831
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effectiveness of Pulsed Electromagnetic Field Therapy on the Management of Chronic Ankle Instability: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05500885
- Acronym / sponsor ID
- 2022.263-T
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 15 Aug 2022 (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.
This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of standard rehabilitation for the treatment of chronic ankle instability. The study objective is to establish whether PEMF plus standard rehabilitation in people with chronic ankle instability compared to standard rehabilitation. This study also investigates the effects of PEMF on pain, functional outcomes, and mechanical and morphological properties of peroneal muscles in chronic ankle instability. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties.
This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for chronic ankle instability. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital.
40 patients aged between 18 to 60 years old with CAI will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=20; PEMF (Quantum Tx) treatment), and the control group (n=20; sham treatment with dummy exposure to PEMF).
For Chronic Ankle Instability patients: baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as dynamic balance, static balance, single leg hop test, gait evaluation, dorsiflexion range of motion, and eversion muscle strength.
Detailed description
The primary objective is to investigate the effectiveness of PEMF therapy on the clinical and functional outcomes in the CAI population. We hypothesize that PEMF therapy will effectively improve the clinical and functional outcomes of patients with CAI.
Methods: This is a prospective, randomized, double-blinded, placebo-controlled trial with blinded assessors. A total of 40 adults with CAI will be recruited and randomly allocated into either the intervention or control group. In the intervention group, the participants (n=20) will receive active PEMF therapy and standard exercise training, while the control group (n=20) will receive sham-PEMF therapy and standard exercise training. The PEMF intervention will last for 8 weeks. The primary and secondary outcomes will be evaluated at baseline, week 4, week 8, 3rd month, 6th month after the PEMF therapy.
Rationale: Pulse electromagnetic field therapy (PEMF) as an adjunct biophysical therapy can improve stability by mitigating peroneal muscle weakness and activating peroneal muscle. Therefore, we postulate the combination of standard care (muscle strengthening, balance training, and range of motion exercise) augmented with pulse electromagnetic field therapy elicits a significant improvement in postural control stability and peroneal muscle weakness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PEMF therapy for chronic ankle instability | Experimental | Device: PEMF device, Quantum Tx, SingaporeParticipants will be randomized into 1:1 allocation, blocked randomization with 20 participants in the PEMF group and 20 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. |
| Sham PEMF therapy for chronic ankle instability | Sham comparator | Other: Standard rehabilitation and sham PEMF therapy for CAIControl group will receive sham treatment on top of a standard rehabilitation (muscle strengthening and balance training). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requires a history of at least one significant sprain > 12 months prior to consent
- Continued perceived or episodic "giving way" of the ankle
- Reported Cumberland Ankle Instability Tool (CAIT score < 24)
Key exclusion criteria (10 listed)
- A history of surgeries or fractures of either lower extremity limbs
- Concomitant lower extremity pathology, e.g. vascular disease and osteoarthritis
- Inadequate muscle strength in lower limb which require ambulation support (e.g., crutches) or any vestibular or balance disorders
- Pregnancy
- Cognitive impairment/Neurological conditions, and neurological disorders (e.g. dementia) -Concussion within the last 6 months
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 |
|---|---|---|
| PEMF device, Quantum Tx, SingaporeThe options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes. | Device | Active PEMF therapy for chronic ankle instability |
| Standard rehabilitation and sham PEMF therapy for CAIBalance training and muscle strengthening | Other | Sham PEMF therapy for chronic ankle instability |
Primary outcome
Centre of pressure during single leg stance for chronic ankle instability
Time frame: Baseline to 6 months
Static balance will be conducted in double-leg and single leg stance with eyes opened and closed on the Tekscan pressure mat.
11 secondary outcomes
Y balance test for chronic ankle instability
Time frame: Baseline to 6 months
Dorsiflexion Range of motion for chronic ankle instability
Time frame: Baseline to 6 months
Foot muscle strength for chronic ankle instability population
Time frame: Baseline to 6 months
Ultrasound imaging for peroneal muscle in chronic ankle instability patients
Time frame: Baseline to 6 months
Short Form 36 questionnaire (SF-36)
Time frame: Baseline to 6 months
CAIT score
Time frame: Baseline to 6 months
Lateral step-down test (LSDT)
Time frame: Baseline to 6 months
The Manchester-Oxford Foot Questionnaire (MOxFQ)
Time frame: Baseline to 6 months
Numerical pain scale for chronic ankle instability
Time frame: Baseline to 6 months
Foot and ankle measure
Time frame: Baseline to 6 months
Dorsiflexion range of motion
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 39627831Chia CSM, Fu SC, He X, Cheng YY, Franco-Obregon A, Hua Y, Yung PS, Ling SK. The clinical effects of pulsed electromagnetic field therapy for the management of chronic ankle instability: a study protocol for a double-blind randomized controlled trial. Trials. 2024 Dec 3;25(1):808. doi: 10.1186/s13063-024-08639-z.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF device, Quantum Tx, Singapore in people with Chronic Ankle Instability, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 25 Mar 2026. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Centre of pressure during single leg stance for chronic ankle instability (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500885, which also lists 1 linked publication.
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 25 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.