Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

NCT02975154 | Completed

• 1 other identifier: MicrocurrencyOA
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis,Knee

Keywords

osteoarthritis; microcurrent; knee; electrotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Knee injury and Osteoarthritis Outcome Score

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

• Short-Form 36

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

• Satisfaction with Treatment (Questionnaire)

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

• Range of Motion knee joint

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

• Get-up-and-Go-Test (GUG)

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

Study Arms (4)

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.

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.

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.

Device: Microcurrent therapy

No Intervention

NO INTERVENTION

No Intervention. Previous treatments will be continued.

Interventions

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.

Microcurrent therapy, type A; Microcurrent therapy, type B; Sham Microcurrent therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Federal Ministry for Economic Affairs and Energy: collaborator

Study Sites (1)

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

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Martin B Weigl

  Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD, MD, MPH (Harvard University)

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: December 5, 2016
• Primary Completion: September 4, 2017
• Study Completion: September 4, 2017
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)