ArthrosisNCT02649296
Effect of Skanlab Regarding Knee Arthrosis
A study testing Skanlab bodywave in people with Arthrosis, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The purpose is to find out the effect of Skanlab at knee arthrosis. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthrosis
- What is being tested?
- Skanlab bodywave
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Dec 2016
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- knee arthrosis in one or both legs
Who cannot join
- Pacemaker
- infusion pump
- cancer
- diabetes
- pregnancy
- blood clots
- bacteriological inflammation
- reduced sensitivity in the treatment area.
Trial locations and contacts
1 site in 1 country.
Hilde Sylliaas, Ass prof contact
Norway1 site, 1 recruiting
- Recruiting
Oslo and Akershus University college of applied science
Oslo, Norway, 0130
Hilde Sylliaas, Ass prof, hilde.sylliaas@hioa.no
About this study
The purpose is to find out the effect of Skanlab at knee arthrosis.
Read the detailed description
The patients diagnosed with knee arthrosis will be treated With Skanlab twice a week for four weeks.
- Conditions
- Arthrosis
- Being tested
- Skanlab bodywave
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skanlab bodywaveOther
The intervention will be done twice a week
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Skanlab Bodywave | Other | Treatment with Skanlab Bodywave twice a week for four weeks at the affected knee. Receives: Other: Skanlab bodywave |
| No treatment | No intervention | Treatment with Skanlab Bodywave without function twice a week for four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
changes in pain
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilde Sylliaas, Oslo Metropolitan University
- Investigators
- Trine Haugen, Prof, Study director, Oslo and Akershus university college of applied science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649296
- Sponsor's protocol ID
- Skanlab
- Status last verified
- Sep 2016
- First submitted
- 29 Oct 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skanlab Regarding Knee Arthrosis
- ClinicalTrials.gov ID
- NCT02649296
- Acronym / sponsor ID
- Skanlab
- Conditions
- Arthrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jan 2016 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Skanlab Bodywave | Other | Other: Skanlab bodywaveTreatment with Skanlab Bodywave twice a week for four weeks at the affected knee. |
| No treatment | No intervention | –Treatment with Skanlab Bodywave without function twice a week for four weeks. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee arthrosis in one or both legs
Key exclusion criteria (8 listed)
- Pacemaker
- infusion pump
- cancer
- diabetes
- pregnancy
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 |
|---|---|---|
| Skanlab bodywaveThe intervention will be done twice a week | Other | Treatment with Skanlab Bodywave |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 15 months
changes in pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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.
Hilde Sylliaas, Ass prof contact
Trine Haugen, Prof study director
Oslo and Akershus university college of applied science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skanlab bodywave in people with Arthrosis, run by Oslo Metropolitan University at 1 site in Norway.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2016. 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 Norway. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilde Sylliaas, Ass prof (hilde.sylliaas@hioa.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: 15 months). 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 28 Sep 2016.