- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07564427
Effects of Additional High-Intensity Pulsed Electromagnetic Field (HI-PEMF) Therapy on Pain and Physical Function After Total Hip Replacement
Effects of Additional High-Intensity Pulsed Electromagnetic Field (HI-PEMF) Therapy on Pain and Physical Function After Total Hip Replacement: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tsang-Ming (倉銘) Chang (張)
- Phone Number: 886-905657069
- Email: nick0223.chang@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
A. Age 18 years or older.
B. Patients who have undergone primary unilateral total hip arthroplasty due to hip osteoarthritis.
C. Patients who, after postoperative evaluation by their surgeon, are advised to bear full weight within their tolerance.
Exclusion Criteria:
A. Patients who have not undergone primary hip arthroplasty.
B. Patients who are advised by their doctor to maintain non-weight-bearing or partial weight-bearing on the affected or unaffected side.
C. History of neurological deficits (e.g., sensory abnormalities, stroke, spinal cord injury, Parkinson's disease, multiple sclerosis).
D. Mini-Mental State Examination (MMSE) < 24 (mild cognitive impairment).
E. Berger's Balance Scale (BBS) < 40 (higher risk of falls).
F. Sensory abnormalities.
G. Before or after this exercise training, if pain in other areas (e.g., degenerative pain in the knee or spine) prevents movement, or if the hip joint still experiences pain on a Visual Analogue Scale (VAS) score of 4 or higher even after taking pain medication.
H. Known malignancy.
I. Schizophrenia, bipolar disorder, or substance addiction (e.g., alcohol, drug).
J. Pregnant woman.
K. Individuals with implanted stents, pacemakers, or those requiring treatment for arrhythmia.
L. Wearing a hearing aid.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 2 :exercise
|
Post operative program exercise for THR
|
|
Experimental: Arm 1:HI-PEMF
HI-PEMF
|
Post operative program exercise for THR
High-Intensity Pulsed Electromagnetic Field (HI-PEMF) is a non-invasive, contactless technology delivering strong magnetic pulses (up to 3 T or more) to biological tissue.
It serves as a superior alternative to traditional electropermeabilization by altering cell membrane permeability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Time Frame: 1-month
|
This scale can measure THR patient pain and function.The standard WOMAC scale (using a 0-4 Likert scale for each of the 24 questions) ranges from 0 to 96.
|
1-month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202601236DIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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