Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

Osteoarthritis,Knee Clinical Trial

Official title:

Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975154
• Other study ID #: MicrocurrencyOA
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: October 11, 2017
• Start date: December 5, 2016
• Est. completion date: September 4, 2017

Study information

• Verified date: October 2017
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 4, 2017
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Device:
• Microcurrent therapy
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.

Locations

Country	Name	City	State
Germany	Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	German Federal Ministry for Economic Affairs and Energy (Funding)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Ratings scale (NRS) for pain (0-10)	numerical Rating scale	Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Secondary	Knee injury and Osteoarthritis Outcome Score	Knee specific Instrument measuring pan, function and Quality of life.	Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Secondary	Short-Form 36	Generic HRQOL measure	Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Secondary	Satisfaction with Treatment (Questionnaire)	Self-administered questionnaire that was developed for this study	Evaluation at the end of treatment (in average 21 days after Start of treatment)
Secondary	Range of Motion knee joint	Clinical test with goniometer	Change: Before treatment vs. end of treatment (in average 21 days later)
Secondary	Get-up-and-Go-Test (GUG)	clinical test that measures mobility	Change: Before treatment vs. end of treatment (in average 21 days later)
Secondary	6-minute walking test	Clinical test that measures the Walking ability	Change: Before treatment vs. end of treatment (in average 21 days later)