OsteoarthrosisNCT01603017
Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis
A study testing MRI therapy and MRI therapy (off) in people with Osteoarthrosis, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the knee joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- MRI therapy and MRI therapy (off)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthrosis of the knee(s)
- Moderately severe (grade 1-2)
Who cannot join
- Prior knee surgery
- Implanted metallic devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis: A Double Blind Ranomised Controlled Trial
Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the knee joint.
The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate oteoarthosis of the knee.
Read the detailed description
This study was approved by the Regional Ethics Committee. Patients were recruited from referrals made by General Practitioners to a single Orthopaedic Outpatient Department between October 2007 and February 2008. The study was a prospective placebo controlled, double blind randomised mono centric study with a follow up period of 6 months.
All potential trial participants demonstrated symptomatic mild to moderate OA of the knee joint diagnosed by an experienced consultant orthopaedic surgeon. Radiographic evidence was gathered by means of standard clinical standing antero-posterior and lateral radiographs of the knee.
Baseline assessment included :
- clinical examination
- active Range of movement
- plain radiographs
- WOMAC osteoarthritis index
- Oxford Knee Score (OKS)
- Severity of pain VAS.
- Strength and frequency of any painkillers taken.
- Phyasiotherapy Study design was directed at use of NMRT in a clinical setting. It was therefore considered valid to not restrict the use of the pain killers and physiotherapy. Positional Magnetic Resonance Imaging (pMRI) scan of the knee joint was undertaken.
Randomisation was carried out by means of visually identical computer chip cards numbered from 1 to 100 which had been independently programmed by the manufacturer. Thus, half of the computer chip cards (n=50) were programmed to activate the magnetic fields (= treatment group) and remaining half (n=50) were programmed not to activate magnetic fields (=placebo group) of the device. The research team and patients were blinded to the programmed activity of the cards. The magnetic resonance indicator LED lamp on the device was disabled by the manufacturer to ensure that the operator and patients were blinded to the therapy status. Every patient entering the study was asked to choose a numbered card from those available, and this card was then used to operate the device for that specific patient for all five sessions of NMRT.
The study used the manufacturer's clinical recommendation for therapy. Patients were subjected to one-hour sessions of NMRT (or placebo) on five consecutive days, giving a total of five hours of NMRT (or placebo). This was given on an outpatient basis.
The device is made up of twelve independently controlled coil systems that are spaced orthogonally. These are designed to produce a 3-dimensional therapy field. Along with a separately generated permanent magnetic field, the 3-dimensional therapy field forms a nuclear resonance field in the center of the coil system. The desired dose of NMRT is achieved with the help of MBST® - Treatment software, which is controlled by a computer chip card. The device can generate a magnetic field of 3.0 mT (typical) and maximum of 10 mT extending up to 30 cm around the device.
Patients were called for review at 1 week (1w), 1 month (1m), 3 months (3m) and 6 months (6m) when clinical examination, WOMAC osteoarthritis index and OKS were repeated. They were also asked to record VAS and details of painkillers taken during the week before each review. Due to the lack of recognised analgesia equivalencies, the quantity of pain killers taken were graded with reference to the amount and frequency taken at baseline - less than baseline was graded as 1, same as baseline was graded as 2 and more than baseline was graded as 3.
- Conditions
- Osteoarthrosis
- Being tested
- MRI therapy, MRI therapy (off)
- Keywords
- Magnetic Resonance Therapy, Osteoarthrosis, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI therapyDevice
Also called MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
5 treatments with magnetic field delivered to knee (n=50)
MRI therapy (off)Device
Also called MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
5 treatment where MRI therapy machine was switched off (both patient and therapist blinded to this by use of electronic 'prescription cards'). (n=50)
| Study group | Role | What they receive |
|---|---|---|
| Placebo - no therapy | Placebo comparator | Patients who were blinded but did not receive therapy Receives: Device: MRI therapy (off) |
| MRI therapy | Experimental | Patients receiving MRI therapy but blinded to it Receives: Device: MRI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score
Patient administered validated questions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Responsible party
- Principal investigator, S Barker, NHS Grampian
- Investigators
- Simon L Barker, MD, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603017
- Sponsor's protocol ID
- 06/S0802/131
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis: A Double Blind Ranomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01603017
- Acronym / sponsor ID
- 06/S0802/131
- Conditions
- Osteoarthrosis
- Keywords
- Magnetic Resonance Therapy, Osteoarthrosis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 May 2012 (estimated)
- 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.
Nuclear Magnetic Resonance Therapy (NMRT) is gaining as a novel mode of therapy in osteoarthrosis. A prospective double blind randomised study of 100 patients was conducted to investigate efficacy of NMRT in the treatment of mild to moderate osteoarthrosis (OA) of the knee joint.
The null hypothesis was that there is no benefit of NMRT over placebo in mild to moderate oteoarthosis of the knee.
Detailed description
This study was approved by the Regional Ethics Committee. Patients were recruited from referrals made by General Practitioners to a single Orthopaedic Outpatient Department between October 2007 and February 2008. The study was a prospective placebo controlled, double blind randomised mono centric study with a follow up period of 6 months.
All potential trial participants demonstrated symptomatic mild to moderate OA of the knee joint diagnosed by an experienced consultant orthopaedic surgeon. Radiographic evidence was gathered by means of standard clinical standing antero-posterior and lateral radiographs of the knee.
Baseline assessment included :
- clinical examination
- active Range of movement
- plain radiographs
- WOMAC osteoarthritis index
- Oxford Knee Score (OKS)
- Severity of pain VAS.
- Strength and frequency of any painkillers taken.
- Phyasiotherapy Study design was directed at use of NMRT in a clinical setting. It was therefore considered valid to not restrict the use of the pain killers and physiotherapy. Positional Magnetic Resonance Imaging (pMRI) scan of the knee joint was undertaken.
Randomisation was carried out by means of visually identical computer chip cards numbered from 1 to 100 which had been independently programmed by the manufacturer. Thus, half of the computer chip cards (n=50) were programmed to activate the magnetic fields (= treatment group) and remaining half (n=50) were programmed not to activate magnetic fields (=placebo group) of the device. The research team and patients were blinded to the programmed activity of the cards. The magnetic resonance indicator LED lamp on the device was disabled by the manufacturer to ensure that the operator and patients were blinded to the therapy status. Every patient entering the study was asked to choose a numbered card from those available, and this card was then used to operate the device for that specific patient for all five sessions of NMRT.
The study used the manufacturer's clinical recommendation for therapy. Patients were subjected to one-hour sessions of NMRT (or placebo) on five consecutive days, giving a total of five hours of NMRT (or placebo). This was given on an outpatient basis.
The device is made up of twelve independently controlled coil systems that are spaced orthogonally. These are designed to produce a 3-dimensional therapy field. Along with a separately generated permanent magnetic field, the 3-dimensional therapy field forms a nuclear resonance field in the center of the coil system. The desired dose of NMRT is achieved with the help of MBST® - Treatment software, which is controlled by a computer chip card. The device can generate a magnetic field of 3.0 mT (typical) and maximum of 10 mT extending up to 30 cm around the device.
Patients were called for review at 1 week (1w), 1 month (1m), 3 months (3m) and 6 months (6m) when clinical examination, WOMAC osteoarthritis index and OKS were repeated. They were also asked to record VAS and details of painkillers taken during the week before each review. Due to the lack of recognised analgesia equivalencies, the quantity of pain killers taken were graded with reference to the amount and frequency taken at baseline - less than baseline was graded as 1, same as baseline was graded as 2 and more than baseline was graded as 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo - no therapy | Placebo comparator | Device: MRI therapy (off)Patients who were blinded but did not receive therapy |
| MRI therapy | Experimental | Device: MRI therapyPatients receiving MRI therapy but blinded to it |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Osteoarthrosis of the knee(s)
- Moderately severe (grade 1-2)
Key exclusion criteria (2 listed)
- Prior knee surgery
- Implanted metallic devices
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 |
|---|---|---|
| MRI therapyAlso: MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany5 treatments with magnetic field delivered to knee (n=50) | Device | MRI therapy |
| MRI therapy (off)Also: MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany5 treatment where MRI therapy machine was switched off (both patient and therapist blinded to this by use of electronic 'prescription cards'). (n=50) | Device | Placebo - no therapy |
Primary outcome
Oxford Knee Score
Time frame: 12 weeks
Patient administered validated questions
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 21 May 2012.
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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.
Simon L Barker, MD principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI therapy and MRI therapy (off) in people with Osteoarthrosis, run by NHS Grampian at 1 site in United Kingdom.
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 2 inclusion and 2 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 21 May 2012. 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 United Kingdom. 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?
Oxford Knee Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2012.