NCT02649296

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

October 29, 2015

Last Update Submit

September 27, 2016

Conditions

Arthrosis

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    changes in pain

    15 months

Study Arms (2)

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

Skanlab bodywaveOTHER

The intervention will be done twice a week

Treatment with Skanlab Bodywave

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee arthrosis in one or both legs

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo and Akershus University college of applied science

Oslo, Norway, 0130, Norway

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Trine Haugen, Prof

    Oslo and Akershus university college of applied science

    STUDY DIRECTOR

Central Study Contacts

Hilde Sylliaas, Ass prof

CONTACT

hilde.sylliaas@hioa.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

October 29, 2015

First Posted

January 7, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

NO(1)