Back to resultsEfficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Repetitive Peripheral Magnetic Stimulation
Education
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
Eligibility Criteria
Inclusion Criteria:
- Primary knee osteoarthritis patients who have had knee pain for at least 6 months and age more than 50 years, had morning stiffness not more than 30 minutes or crepitation.
- Kellgren and Lawrence classification 2-4
- Visual analog scale of pain 4 or higher.
Exclusion Criteria:
- Patients with other musculoskeletal problems associated with knee joint
- Patient with history of physical therapy in past 1 month
- Patient with pacemaker, cochlear implant or cerebral shunt
- Patient with history of knee surgery
- Patient with neurological or other severe disease
- Patient with previous seizure.
Sites / Locations
- Physical medicine and rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Repetitive Peripheral Magnetic Stimulation
Sham Repetitive Peripheral Magnetic Stimulation
Arm Description
Repetitive Peripheral Magnetic Stimulation 1 session
Sham Repetitive Peripheral Magnetic Stimulation 1 session
Outcomes
Primary Outcome Measures
Change of Visual analog scale
Pain measurement Score from 0-10, 0 means no pain and 10 means maximum pain. Higher scores mean worse outcome.
Secondary Outcome Measures
Modified Western Ontario and McMaster University Osteoarthritis Index
To assessing pain, stiffness, and function in patients with osteoarthritis. Score from 0-220. Higher scores mean worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484752
Brief Title
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.
Official Title
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Repetitive Peripheral Magnetic Stimulation
Arm Type
Experimental
Arm Description
Repetitive Peripheral Magnetic Stimulation 1 session
Arm Title
Sham Repetitive Peripheral Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
Sham Repetitive Peripheral Magnetic Stimulation 1 session
Intervention Type
Device
Intervention Name(s)
Repetitive Peripheral Magnetic Stimulation
Intervention Description
Repetitive Peripheral Magnetic Stimulation at knee joint 1 session
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Conventional exercise and life style modification
Primary Outcome Measure Information:
Title
Change of Visual analog scale
Description
Pain measurement Score from 0-10, 0 means no pain and 10 means maximum pain. Higher scores mean worse outcome.
Time Frame
Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week.
Secondary Outcome Measure Information:
Title
Modified Western Ontario and McMaster University Osteoarthritis Index
Description
To assessing pain, stiffness, and function in patients with osteoarthritis. Score from 0-220. Higher scores mean worse outcome.
Time Frame
Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary knee osteoarthritis patients who have had knee pain for at least 6 months and age more than 50 years, had morning stiffness not more than 30 minutes or crepitation.
Kellgren and Lawrence classification 2-4
Visual analog scale of pain 4 or higher.
Exclusion Criteria:
Patients with other musculoskeletal problems associated with knee joint
Patient with history of physical therapy in past 1 month
Patient with pacemaker, cochlear implant or cerebral shunt
Patient with history of knee surgery
Patient with neurological or other severe disease
Patient with previous seizure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apiphan Iamchaimongkol, M.D.
Organizational Affiliation
Mahidol University, Ramathibodi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Physical medicine and rehabilitation
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9665594
Citation
Pujol J, Pascual-Leone A, Dolz C, Delgado E, Dolz JL, Aldoma J. The effect of repetitive magnetic stimulation on localized musculoskeletal pain. Neuroreport. 1998 Jun 1;9(8):1745-8. doi: 10.1097/00001756-199806010-00014.
Results Reference
result
Links:
URL
http://doi.org/10.1097/00001756-199806010-00014
Description
The effect of repetitive magnetic stimulation on localized musculoskeletal pain.
Learn more about this trial
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.
We'll reach out to this number within 24 hrs