Osteoarthritis of KneeNCT05484752
Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.
A study testing Repetitive Peripheral Magnetic Stimulation and Education in people with Osteoarthritis of Knee, run by Mahidol University at 1 site in Thailand.
Trial summary
To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Repetitive Peripheral Magnetic Stimulation and Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2019to 30 Mar 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Osteoarthritis of Knee
- Being tested
- Repetitive Peripheral Magnetic Stimulation, Education
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Peripheral Magnetic StimulationDevice
Repetitive Peripheral Magnetic Stimulation at knee joint 1 session
EducationBehavioural
Conventional exercise and life style modification
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Peripheral Magnetic Stimulation | Experimental | Repetitive Peripheral Magnetic Stimulation 1 session Receives: Device: Repetitive Peripheral Magnetic Stimulation; Behavioral: Education |
| Sham Repetitive Peripheral Magnetic Stimulation | Sham comparator | Sham Repetitive Peripheral Magnetic Stimulation 1 session Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To assessing pain, stiffness, and function in patients with osteoarthritis. Score from 0-220. Higher scores mean worse outcome.
Measured: Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Aug 2019
- Primary completion1 Aug 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apiphan Iamchaimongkol, M.D., Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484752
- Sponsor's protocol ID
- ApiphanRama
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9665594
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05484752
- Acronym / sponsor ID
- ApiphanRama
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Aug 2022 (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.
To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive Peripheral Magnetic Stimulation | Experimental | Device: Repetitive Peripheral Magnetic Stimulation, Behavioral: EducationRepetitive Peripheral Magnetic Stimulation 1 session |
| Sham Repetitive Peripheral Magnetic Stimulation | Sham comparator | Behavioral: EducationSham Repetitive Peripheral Magnetic Stimulation 1 session |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Repetitive Peripheral Magnetic StimulationRepetitive Peripheral Magnetic Stimulation at knee joint 1 session | Device | Repetitive Peripheral Magnetic Stimulation |
| EducationConventional exercise and life style modification | Behavioural | Repetitive Peripheral Magnetic Stimulation, Sham Repetitive Peripheral Magnetic Stimulation |
Primary outcome
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.
1 secondary outcome
Modified Western Ontario and McMaster University Osteoarthritis Index
Time frame: Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.
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 12 Aug 2022.
- Results publication: PubMed 9665594Pujol 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.
- The effect of repetitive magnetic stimulation on localized musculoskeletal pain.Link provided by the sponsor.
- 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.
Apiphan Iamchaimongkol, M.D. study director
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Peripheral Magnetic Stimulation and Education in people with Osteoarthritis of Knee, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 6 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 12 Aug 2022. 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 Thailand. 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 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484752, which also lists 1 linked publication.
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 12 Aug 2022.