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Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis

Primary Purpose

Osteoarthrosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI therapy
MRI therapy (off)
Sponsored by
NHS Grampian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis focused on measuring Magnetic Resonance Therapy, Osteoarthrosis, Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Osteoarthrosis of the knee(s)
  • Moderately severe (grade 1-2)

Exclusion Criteria:

  • Prior knee surgery
  • Implanted metallic devices

Sites / Locations

  • Woodend Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo - no therapy

MRI therapy

Arm Description

Patients who were blinded but did not receive therapy

Patients receiving MRI therapy but blinded to it

Outcomes

Primary Outcome Measures

Oxford Knee Score
Patient administered validated questions

Secondary Outcome Measures

Full Information

First Posted
May 15, 2012
Last Updated
May 17, 2012
Sponsor
NHS Grampian
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1. Study Identification

Unique Protocol Identification Number
NCT01603017
Brief Title
Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis
Official Title
Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis: A Double Blind Ranomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Grampian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis
Keywords
Magnetic Resonance Therapy, Osteoarthrosis, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo - no therapy
Arm Type
Placebo Comparator
Arm Description
Patients who were blinded but did not receive therapy
Arm Title
MRI therapy
Arm Type
Experimental
Arm Description
Patients receiving MRI therapy but blinded to it
Intervention Type
Device
Intervention Name(s)
MRI therapy
Other Intervention Name(s)
MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
Intervention Description
5 treatments with magnetic field delivered to knee (n=50)
Intervention Type
Device
Intervention Name(s)
MRI therapy (off)
Other Intervention Name(s)
MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
Intervention Description
5 treatment where MRI therapy machine was switched off (both patient and therapist blinded to this by use of electronic 'prescription cards'). (n=50)
Primary Outcome Measure Information:
Title
Oxford Knee Score
Description
Patient administered validated questions
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthrosis of the knee(s) Moderately severe (grade 1-2) Exclusion Criteria: Prior knee surgery Implanted metallic devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon L Barker, MD
Organizational Affiliation
NHS Grampian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woodend Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB15 6XS
Country
United Kingdom

12. IPD Sharing Statement

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Nuclear Magnetic Resonance Therapy in Knee Osteoarthrosis

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