Whole-Body Electromyostimulation and Knee Osteoarthritis

NCT ID: NCT05672264

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-04-01

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.

Detailed Description

Studies consistently show a positive effect of strength training on pain and function in knee osteoarthritis. In addition to local neuromuscular effects, systemic mechanisms that modulate inflammatory processes are increasingly being discussed as mechanisms of action. Overweight and obesity might be involved in this process. Despite high evidence, unfortunately only few people with osteoarthritic knee pain are willing or able to perform conventional muscular strength training on a regular basis. In this context, whole-body electromyostimulation (WB-EMS) is a time-efficient, joint-friendly and subjectively less strenuous training alternative. In WB-EMS, all large muscle groups of the body are simultaneously activated and brought to contraction by electrical impulses. Together with easy movements with minor mechanical stress on the knee joint, the additive WB-EMS activates muscle contraction and results in measurable muscular effects.

The aim of the present study is to evaluate the effects of a 6-month WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial (RCT) 72 overweight patients (BMI >25 kg/m2) with knee osteoarthritis (radiographic severity Kellgren-Lawrence 2 and 3) 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 (85 Hz, 350 µs) 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.

At baseline, after 6 months of intervention and after a further 6 months of follow-up, knee pain and function will be determined by the KOOS instrument (Knee Injury and Osteoarthritis Outcome Score). Functional tests and isokinetic leg strength measurements will also be performed. In parallel, MRI assessments are applied to quantify effects on joint structure (whole organ assessment; MRI Osteoarthritis Knee Score (MOAKS)) and visceral fat as well as muscle quality changes at the mid-thigh. Whole body composition analyses are performed using segmental whole-body bioimpedance analysis (BIA) for quantification of body fat and fat-free mass. Blood samples are obtained at baseline, 6 and 12 months to determine inflammatory biomarkers (CRP, IL-1beta, MMP-3) and cartilage formation (PIINP).

The study will provide evidence and detailed insights of the WB-EMS induced effects on pain, function, muscle structure and strength, body composition, joint tissues and anti-inflammatory effects in knees with osteoarthritis. From a clinical perspective, the study will provide important information regarding a promising non-pharmacological therapeutic approach for the treatment of knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WB-EMS group

WB-EMS application

Group Type: EXPERIMENTAL

Whole-Body Electromyostimulation

Intervention Type: 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.

Control

Standardised physiotherapy (six sessions)

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Six standardised physiotherapy sessions (20 min each)

Interventions

Whole-Body Electromyostimulation

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.

Intervention Type: OTHER

Physiotherapy

Six standardised physiotherapy sessions (20 min each)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Kast, MSc

Role: PRINCIPAL_INVESTIGATOR

Institute of Radiology, University Hospital-Nürnberg

Locations

Institute of Medical Physics University of Erlangen-Nurnberg

Erlangen, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 36111142 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35812334 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33716787 (View on PubMed)

Other Identifiers

UKER_EMS_Knee

Identifier Type: -

Identifier Source: org_study_id