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

NCT05500885 | Completed DMC

• 1 other identifier: 2022.263-T
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 months

Secondary Outcomes (11)

• Y balance test for chronic ankle instability

  Baseline to 6 months

• Dorsiflexion Range of motion for chronic ankle instability

  Baseline to 6 months

• Foot muscle strength for chronic ankle instability population

  Baseline to 6 months

• Ultrasound imaging for peroneal muscle in chronic ankle instability patients

  Baseline to 6 months

• Short Form 36 questionnaire (SF-36)

  Baseline to 6 months

Study Arms (2)

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.

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).

Other: Standard rehabilitation and sham PEMF therapy for CAI

Interventions

Standard rehabilitation and sham PEMF therapy for CAI OTHER

Balance training and muscle strengthening

Sham PEMF therapy for chronic ankle instability

PEMF device, Quantum Tx, Singapore DEVICE

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

Active PEMF therapy for chronic ankle instability

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, New Territories, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39627831 DERIVED

MeSH Terms

Interventions

carboxyamido-triazole

Study Design

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

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 15, 2022
• Study Start: January 2, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)