A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis

NCT03332914 | Completed

• 1 other identifier: MicrocurrencyCrossover
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group. In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; microcurrent; knee; electrotherapy

Outcome Measures

Primary Outcomes (1)

• Numerical Rating 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 (2)

First group

ACTIVE COMPARATOR

control group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10

Device: Microcurrent therapy

Second group

ACTIVE COMPARATOR

Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group

Device: Microcurrent therapy

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.

First group; Second group

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, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD, MD, MPH (Harvard University)

Model Details: Crossover

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: November 2, 2017
• Primary Completion: November 27, 2017
• Study Completion: December 27, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)