Osteoarthritis,KneeNCT02975154
Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee
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 study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. 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?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 5 Dec 2016to 4 Sep 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, 81377
About this study
Official title: Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study
This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.
Read the detailed description
The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.
Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.
- 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 |
|---|---|---|
| Microcurrent therapy, type A | Active comparator | Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10.
Previous treatments will be continued. Receives: Device: Microcurrent therapy |
| Microcurrent therapy, type B | Active comparator | Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. Receives: Device: Microcurrent therapy |
| Sham Microcurrent therapy | Sham comparator | Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. Receives: Device: Microcurrent therapy |
| No Intervention | No intervention | No Intervention. Previous treatments will be continued. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Ratings 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 posted29 Nov 2016 (estimated)
- Study start5 Dec 2016
- Primary completion4 Sep 2017
- Study completion4 Sep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 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
- Investigators
- Martin B Weigl, Principal investigator, Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975154
- Sponsor's protocol ID
- MicrocurrencyOA
- Status last verified
- Oct 2017
- First submitted
- 21 Nov 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02975154
- Acronym / sponsor ID
- MicrocurrencyOA
- Conditions
- Osteoarthritis,Knee
- Keywords
- osteoarthritis, microcurrent, knee, electrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Federal Ministry for Economic Affairs and Energy
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 29 Nov 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.
This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.
Detailed description
The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.
Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microcurrent therapy, type A | Active comparator | Device: Microcurrent therapyMicrocurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
| Microcurrent therapy, type B | Active comparator | Device: Microcurrent therapyMicrocurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
| Sham Microcurrent therapy | Sham comparator | Device: Microcurrent therapyMicrocurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
| No Intervention | No intervention | –No Intervention. Previous treatments will be continued. |
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 | Microcurrent therapy, type A, Microcurrent therapy, type B, Sham Microcurrent therapy |
Primary outcome
Numerical Ratings 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 12 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Martin B Weigl principal investigator
Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
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 12 Oct 2017. 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. Some participants in this study may receive a placebo. 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 Ratings 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 12 Oct 2017.