NCT01603017

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

May 15, 2012

Last Update Submit

May 17, 2012

Conditions

Osteoarthrosis

Keywords

Magnetic Resonance TherapyOsteoarthrosisOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score

    Patient administered validated questions

    12 weeks

Study Arms (2)

Placebo - no therapy

PLACEBO COMPARATOR

Patients who were blinded but did not receive therapy

Device: MRI therapy (off)

MRI therapy

EXPERIMENTAL

Patients receiving MRI therapy but blinded to it

Device: MRI therapy

Interventions

MRI therapyDEVICE

5 treatments with magnetic field delivered to knee (n=50)

Also known as: MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
MRI therapy
MRI therapy (off)DEVICE

5 treatment where MRI therapy machine was switched off (both patient and therapist blinded to this by use of electronic 'prescription cards'). (n=50)

Also known as: MBST-01, Version KSRT, Type 300 KSRT,, Serial Nos. 12100411 and 23490318,, manufactured by AD Elektronik GmbH, Wetzlar, Germany
Placebo - no therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior knee surgery
  • Implanted metallic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodend Hospital

Aberdeen, Scotland, AB15 6XS, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Simon L Barker, MD

    NHS Grampian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic Surgeon

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 21, 2012

Study Start

September 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

GB(1)