Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.

August 10, 2022 updated by: Mahidol University

Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis: A Randomized Controlled Trial.

To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Peripheral Magnetic Stimulation
Repetitive Peripheral Magnetic Stimulation 1 session
Device: Repetitive Peripheral Magnetic Stimulation
Repetitive Peripheral Magnetic Stimulation at knee joint 1 session
Behavioral: Education
Conventional exercise and life style modification
Sham Comparator: Sham Repetitive Peripheral Magnetic Stimulation
Sham Repetitive Peripheral Magnetic Stimulation 1 session
Behavioral: Education
Conventional exercise and life style modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Visual analog scale
Time Frame: Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week.
Pain measurement Score from 0-10, 0 means no pain and 10 means maximum pain. Higher scores mean worse outcome.
Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Western Ontario and McMaster University Osteoarthritis Index
Time Frame: Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.
To assessing pain, stiffness, and function in patients with osteoarthritis. Score from 0-220. Higher scores mean worse outcome.
Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Apiphan Iamchaimongkol, M.D., Mahidol University, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ApiphanRama

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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