NCT05484752

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

Same day

First QC Date

August 1, 2022

Last Update Submit

August 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week.

Secondary Outcomes (1)

  • Modified Western Ontario and McMaster University Osteoarthritis Index

    Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.

Study Arms (2)

Repetitive Peripheral Magnetic Stimulation

EXPERIMENTAL

Repetitive Peripheral Magnetic Stimulation 1 session

Device: Repetitive Peripheral Magnetic StimulationBehavioral: Education

Sham Repetitive Peripheral Magnetic Stimulation

SHAM COMPARATOR

Sham Repetitive Peripheral Magnetic Stimulation 1 session

Behavioral: Education

Interventions

Repetitive Peripheral Magnetic Stimulation at knee joint 1 session

Repetitive Peripheral Magnetic Stimulation
EducationBEHAVIORAL

Conventional exercise and life style modification

Repetitive Peripheral Magnetic StimulationSham Repetitive Peripheral Magnetic Stimulation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical medicine and rehabilitation

Bangkok, Thailand

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Apiphan Iamchaimongkol, M.D.

    Ramathibodi Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 2, 2022

Study Start

August 1, 2019

Primary Completion

August 1, 2019

Study Completion

March 30, 2020

Last Updated

August 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations