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NCT Number: NCT02975154

Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

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.

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Key information

Conditions

Osteoarthritis,Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Microcurrent therapy

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score

    Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)

    Knee specific Instrument measuring pan, function and Quality of life.

  2. Short-Form 36

    Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)

    Generic HRQOL measure

  3. Satisfaction with Treatment (Questionnaire)

    Time frame: Evaluation at the end of treatment (in average 21 days after Start of treatment)

    Self-administered questionnaire that was developed for this study

  4. Range of Motion knee joint

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    Clinical test with goniometer

  5. Get-up-and-Go-Test (GUG)

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    clinical test that measures mobility

  6. 6-minute walking test

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    Clinical test that measures the Walking ability

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Federal Ministry for Economic Affairs and Energy

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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