Effect of Skanlab Regarding Knee Arthrosis | NCT02649296

Studies
Effect of Skanlab Regarding Knee Arthrosis

NCT02649296

Sponsor

Oslo Metropolitan University

Status

Unknown status

Last Update Posted

Sep 28, 2016Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Arthrosis

Interventions

Skanlab bodywave

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Dec 2016Estimated

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Jan 6, 2016

First Posted Date

Jan 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2016

Last Update Posted Date

Sep 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose is to find out the effect of Skanlab at knee arthrosis.

Detailed Description

The patients diagnosed with knee arthrosis will be treated With Skanlab twice a week for four weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with Skanlab Bodywave	Other	Treatment with Skanlab Bodywave twice a week for four weeks at the affected knee.	Other: Skanlab bodywave
No treatment	No Intervention	Treatment with Skanlab Bodywave without function twice a week for four weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skanlab bodywave	Other	The intervention will be done twice a week	Treatment with Skanlab Bodywave

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)	changes in pain	15 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

knee arthrosis in one or both legs

Exclusion Criteria:

Pacemaker
infusion pump
cancer
diabetes
pregnancy
blood clots
bacteriological inflammation
reduced sensitivity in the treatment area.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hilde Sylliaas, Ass prof	Contact			hilde.sylliaas@hioa.no

Overall Officials

Name	Affiliation	Role
Trine Haugen, Prof	Oslo and Akershus university college of applied science	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo and Akershus University college of applied science	Recruiting	Oslo	Norway	0130	Norway

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided