Clinical trial NCT02975154: Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee
Official title: Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis,Knee
Keywords: osteoarthritis
microcurrent
knee
electrotherapy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Federal Ministry for Economic Affairs and Energy
First posted: 2016-11-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee
* pain intensity \> 3 on the numerical rating scale (0-10)

Exclusion Criteria:

* knee arthroplasty
* gravity
* dermal Irritation at the skin of the knee
* carcinoma
* known osteoarthritis grade 4 (Kellgren and Lawrence score)

Primary outcomes:
measure: Numerical Ratings scale (NRS) for pain (0-10)
timeFrame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
measure: Short-Form 36
timeFrame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
measure: Satisfaction with Treatment (Questionnaire)
timeFrame: Evaluation at the end of treatment (in average 21 days after Start of treatment)
measure: Range of Motion knee joint
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
measure: Get-up-and-Go-Test (GUG)
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
measure: 6-minute walking test
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Study officials:
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
name: Martin B Weigl
role: PRINCIPAL_INVESTIGATOR
References: