NCT06239103

Brief Summary

The goal of this clinical trial is to assess the effectiveness of pulsed electromagnetic field therapy as an adjunct to warm-up exercises, in healthy participants. Researchers will investigate both the immediate effect of one round of pulsed electromagnetic field therapy (PEMF) and after a warm-up exercise, on participants' range-of-motion (ROM) at the knee and quadriceps' muscle stiffness, measured through shear wave elastography, an ultrasound technique. This may be useful in future interventions to protect against sports injuries. Participants will have their knee ROM and quadriceps' muscle stiffness measured thrice, once at baseline, once after PEMF/sham treatment, and once after 5 minutes of warm-up stationary bike exercises. Researchers will compare with sham treatment to see if there are any significant effects from PEMF therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

15 days

First QC Date

January 25, 2024

Last Update Submit

February 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in knee range-of-motion from baseline immediately after PEMF and after warm-up exercise, as assessed by goniometer

    A goniometer will be used to measure the knee range-of-motion: the static arm will follow a line joining the knee to the greater trochanter of the femur, and the moving arm a line from the knee to the lateral malleolus of the ankle

    From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour

Secondary Outcomes (1)

  • Change in quadriceps muscle stiffness from baseline immediately after PEMF and after warm-up exercise, as assessed by ultrasound shear wave elastography

    From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour

Study Arms (2)

PEMF treatment arm

EXPERIMENTAL

Participants receive PEMF therapy. During this, the participant is seated with their right leg extended and with the bore of the PEMF machine between their knee and hip joints, with their left leg at rest. PEMF was applied at 1 mT, 15 Hz for 10 minutes.

Device: Pulsed electromagnetic field therapy

Control arm

SHAM COMPARATOR

Participants receive sham therapy, where the PEMF machine does not apply the pulsed electromagnetic waves. However, during this, the participant is kept in the same position as those in the treatment arm.

Device: Sham treatment

Interventions

Pulsed electromagnetic field therapy for 10 minutes, using a PEMF device, at 1 mT, 15 Hz.

PEMF treatment arm

Sham treatment, using the same PEMF device

Control arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40
  • Obtained written informed consent

You may not qualify if:

  • History of major musculoskeletal or locomotor system disorder of lower limb
  • History of traumatic or non-traumatic injury of lower limb
  • History of surgical intervention of lower limb in the past 1 year
  • Under any rehabilitation program at the time of investigation
  • Contraindicated to physical exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK-ORT Sports Injury Research Laboratory

Hong Kong, 000000, Hong Kong

Location

Study Officials

  • Justine Tin Nok Chan

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student Researcher

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

August 30, 2022

Primary Completion

September 14, 2022

Study Completion

September 14, 2022

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations