The Clinical Effectiveness of Pulsed Electromagnetic Field Therapy on the Management of Chronic Ankle Instability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Ankle Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active PEMF therapy for chronic ankle instability

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.

Group Type EXPERIMENTAL

PEMF device, Quantum Tx, Singapore

Intervention Type DEVICE

The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.

Sham PEMF therapy for chronic ankle instability

Control group will receive sham treatment on top of a standard rehabilitation (muscle strengthening and balance training).

Group Type SHAM_COMPARATOR

Standard rehabilitation and sham PEMF therapy for CAI

Intervention Type OTHER

Balance training and muscle strengthening

Interventions

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PEMF device, Quantum Tx, Singapore

The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.

Intervention Type DEVICE

Standard rehabilitation and sham PEMF therapy for CAI

Balance training and muscle strengthening

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
* Regular use of medicine or antibiotics
* Metal implantation in their body
* Unable to walk at enrolment
* Non-removable cast

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes