Knee Range-of-motionNCT06239103
Effect of Pulsed Electromagnetic Field Therapy as an Adjunct Modality to Warm-up Exercise
A study testing Pulsed electromagnetic field therapy in people with Knee Range-of-motion and Quadriceps Muscle Stiffness, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Range-of-motion, Quadriceps Muscle Stiffness
- What is being tested?
- Pulsed electromagnetic field therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Aug 2022to 14 Sep 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40
- Obtained written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
CUHK-ORT Sports Injury Research Laboratory
Hong Kong, 000000
About this study
Official title: Effectiveness of Pulsed Electromagnetic Field Therapy as an Adjunct Modality to Warm-up Exercise: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Baseline measurement of knee ROM and quadriceps' muscle stiffness
- Receive PEMF for ten minutes around their knee joint
- Interim measurement of knee ROM and quadriceps' muscle stiffness
- Perform 5 minutes of warm-up exercise on a stationary bike
- Final measurement of knee ROM and quadriceps' muscle stiffness
Researchers will compare with sham treatment to see if there are any significant effects from PEMF therapy.
- Conditions
- Knee Range-of-motion, Quadriceps Muscle Stiffness
- Being tested
- Pulsed electromagnetic field therapy, Sham treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field therapyDevice
Pulsed electromagnetic field therapy for 10 minutes, using a PEMF device, at 1 mT, 15 Hz.
Sham treatmentDevice
Sham treatment, using the same PEMF device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Ultrasound imaging and shear wave elastography will be used to measure the stiffness of the three superficial quadriceps muscles (vastus medialis, vastus lateralis and rectus femoris). Markings will be made to standardise the position of scanning. Ultrasound imaging will be used to verify the muscle being scanned. After shear wave is applied and a stable image is obtained, Young's modulus will be measured as a measure of muscle stiffness.
Measured: From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start30 Aug 2022
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Range-of-motionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Tin Nok Chan, University of Cambridge
- Investigators
- Justine Tin Nok Chan, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239103
- Sponsor's protocol ID
- 202.616-T
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulsed Electromagnetic Field Therapy as an Adjunct Modality to Warm-up Exercise: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06239103
- Acronym / sponsor ID
- 202.616-T
- Conditions
- Knee Range-of-motion, Quadriceps Muscle Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 2 Feb 2024 (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.
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.
Detailed description
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.
- Baseline measurement of knee ROM and quadriceps' muscle stiffness
- Receive PEMF for ten minutes around their knee joint
- Interim measurement of knee ROM and quadriceps' muscle stiffness
- Perform 5 minutes of warm-up exercise on a stationary bike
- Final measurement of knee ROM and quadriceps' muscle stiffness
Researchers will compare with sham treatment to see if there are any significant effects from PEMF therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEMF treatment arm | Experimental | Device: Pulsed electromagnetic field therapyParticipants 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. |
| Control arm | Sham comparator | Device: Sham treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 40
- Obtained written informed consent
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pulsed electromagnetic field therapyPulsed electromagnetic field therapy for 10 minutes, using a PEMF device, at 1 mT, 15 Hz. | Device | PEMF treatment arm |
| Sham treatmentSham treatment, using the same PEMF device | Device | Control arm |
Primary outcome
Change in knee range-of-motion from baseline immediately after PEMF and after warm-up exercise, as assessed by goniometer
Time frame: From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour
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
1 secondary outcome
Change in quadriceps muscle stiffness from baseline immediately after PEMF and after warm-up exercise, as assessed by ultrasound shear wave elastography
Time frame: From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour
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 2 Feb 2024.
- 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.
Justine Tin Nok Chan principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field therapy in people with Knee Range-of-motion and Quadriceps Muscle Stiffness, 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 2 inclusion and 5 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 2 Feb 2024. 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?
Change in knee range-of-motion from baseline immediately after PEMF and after warm-up exercise, as assessed by goniometer (time frame: From before PEMF/sham treatment to end of treatment and warm-up exercise, within 1 hour). 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 2 Feb 2024.