Whole-Body Electromyostimulation and Knee Osteoarthritis

NCT05672264 | Completed Phase 3

• 1 other identifier: UKER_EMS_Knee
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Knee pain

  Changes in pain of the knee joint as determined by the Knee Injury and Osteoarthritis Outcome Score (KOOS) in the WB-EMS- compared to changes in the control group.KOOS score for "knee pain" vary from 1 (never/no pain) to 5 (always/very severe pain)

  baseline to 6 month follow up

Secondary Outcomes (18)

• Self rated symptoms

  baseline to 6-month follow-up

• Knee stiffness

  baseline to 6-month follow-up

• Function in daily living

  baseline to 6-month follow-up

• Function in sports and recreational activities

  baseline to 6-month follow-up

• Quality of Life

  baseline to 6-month follow-up

Other Outcomes (2)

• Drop-out rate

  baseline to 6-month follow-up

• Attendance rate

  baseline to 6-month follow-up

Study Arms (2)

WB-EMS group

EXPERIMENTAL

WB-EMS application

Other: Whole-Body Electromyostimulation

Control

ACTIVE COMPARATOR

Standardised physiotherapy (six sessions)

Other: Physiotherapy

Interventions

Whole-Body Electromyostimulation OTHER

Consistently supervised, video-guided WB-EMS application 1.5 times per week for 28 weeks. Bipolar electric current with a frequency of 85Hz, an impulse-width of 350 µs will be used in an interval approach with 6 sec of EMS stimulation with a direct impulse boost and 4 sec of rest. Low intensity movements or exercises in a standing position were performed during the 6 s stimulation period.

WB-EMS group

Physiotherapy OTHER

Six standardised physiotherapy sessions (20 min each)

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight (BMI\>25 kg/m2)
• radiographically confirmed early to moderate femorotibial osteoarthritis (Kellgren- Lawrence grades 2 and 3)
• osteoarthritic knee pain for at least 3 months
• average pain intensity \> 2.5 (NRS 0-10)

You may not qualify if:

• WB-EMS in the last year or resistance exercise \>1 session/week in the last year
• present glucocorticoid or opioid medication
• trauma of the knee joint within the last 3 months
• intra-articular injections in the knee joint within the last 3 months
• malignant diseases
• serious cardiovascular diseases
• conditions or diseases that are contraindications for WB-EMS
• absence ≥3 weeks during the intervention period

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, 91052, Germany

Location

Related Publications (3)

• Kemmler W, Kleinoder H, Frohlich M. Editorial: Whole-body electromyostimulation: A training technology to improve health and performance in humans? volume II. Front Physiol. 2022 Aug 5;13:972011. doi: 10.3389/fphys.2022.972011. eCollection 2022. No abstract available.

  PMID: 36111142 RESULT

• Bloeckl J, Raps S, Weineck M, Kob R, Bertsch T, Kemmler W, Schoene D. Feasibility and Safety of Whole-Body Electromyostimulation in Frail Older People-A Pilot Trial. Front Physiol. 2022 Jun 24;13:856681. doi: 10.3389/fphys.2022.856681. eCollection 2022.

  PMID: 35812334 RESULT

• Kemmler W, Shojaa M, Steele J, Berger J, Frohlich M, Schoene D, von Stengel S, Kleinoder H, Kohl M. Efficacy of Whole-Body Electromyostimulation (WB-EMS) on Body Composition and Muscle Strength in Non-athletic Adults. A Systematic Review and Meta-Analysis. Front Physiol. 2021 Feb 26;12:640657. doi: 10.3389/fphys.2021.640657. eCollection 2021.

  PMID: 33716787 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Stephanie Kast, MSc

  Institute of Radiology, University Hospital-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 5, 2023
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: April 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)