Osteoarthritis, KneeNCT03332914
A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
A study testing Microcurrent therapy in people with Osteoarthritis, Knee, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Microcurrent therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2017to 27 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee
- pain intensity > 3 on the numerical rating scale (0-10)
Who cannot join
- knee arthroplasty
- gravity
- dermal Irritation at the skin of the knee
- carcinoma
- known osteoarthritis grade 4 (Kellgren and Lawrence score)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Munich, Bavaria, 81377
About this study
This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group.
In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).
Read the detailed description
The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A.
The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Microcurrent therapy
- Keywords
- Osteoarthritis, microcurrent, knee, electrotherapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent therapyDevice
The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.
| Study group | Role | What they receive |
|---|---|---|
| First group | Active comparator | control group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 Receives: Device: Microcurrent therapy |
| Second group | Active comparator | Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10
after washing out control group Receives: Device: Microcurrent therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating scale (NRS) for pain (0-10)
numerical Rating scale
Measured: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Secondary outcomes (6)
Knee injury and Osteoarthritis Outcome Score
Knee specific Instrument measuring pan, function and Quality of life.
Measured: Change of scores: Before treatment vs. end of treatment (in average 21 days later
Short-Form 36
Generic HRQOL measure
Measured: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Satisfaction with Treatment (Questionnaire)
Self-administered questionnaire that was developed for this study
Measured: Evaluation at the end of treatment (in average 21 days after Start of treatment)
Range of Motion knee joint
Clinical test with goniometer
Measured: Change: Before treatment vs. end of treatment (in average 21 days later)
Get-up-and-Go-Test (GUG)
clinical test that measures mobility
Measured: Change: Before treatment vs. end of treatment (in average 21 days later)
6-minute walking test
Clinical test that measures the Walking ability
Measured: Change: Before treatment vs. end of treatment (in average 21 days later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start2 Nov 2017
- Primary completion27 Nov 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry for Economic Affairs and Energy
- Responsible party
- Principal investigator, PD Dr. Martin Weigl, MPH, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332914
- Sponsor's protocol ID
- MicrocurrencyCrossover
- Status last verified
- Aug 2019
- First submitted
- 2 Nov 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03332914
- Acronym / sponsor ID
- MicrocurrencyCrossover
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, microcurrent, knee, electrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Federal Ministry for Economic Affairs and Energy
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group.
In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).
Detailed description
The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A.
The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover
| Arm | Type | Receives |
|---|---|---|
| First group | Active comparator | Device: Microcurrent therapycontrol group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 |
| Second group | Active comparator | Device: Microcurrent therapyMicrocurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis of the knee
- pain intensity > 3 on the numerical rating scale (0-10)
Key exclusion criteria (5 listed)
- knee arthroplasty
- gravity
- dermal Irritation at the skin of the knee
- carcinoma
- known osteoarthritis grade 4 (Kellgren and Lawrence score)
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 |
|---|---|---|
| Microcurrent therapyThe microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used. | Device | First group, Second group |
Primary outcome
Numerical Rating scale (NRS) for pain (0-10)
Time frame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
numerical Rating scale
6 secondary outcomes
Knee injury and Osteoarthritis Outcome Score
Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later
Short-Form 36
Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Satisfaction with Treatment (Questionnaire)
Time frame: Evaluation at the end of treatment (in average 21 days after Start of treatment)
Range of Motion knee joint
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
Get-up-and-Go-Test (GUG)
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
6-minute walking test
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent therapy in people with Osteoarthritis, Knee, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating scale (NRS) for pain (0-10) (time frame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)). 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 13 Aug 2019.