Clinical trial NCT05672264: Whole-Body Electromyostimulation and Knee Osteoarthritis
Official title: Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Knee pain
timeFrame: baseline to 6 month follow up
Secondary outcomes:
measure: Self rated symptoms
timeFrame: baseline to 6-month follow-up
measure: Knee stiffness
timeFrame: baseline to 6-month follow-up
measure: Function in daily living
timeFrame: baseline to 6-month follow-up
measure: Function in sports and recreational activities
timeFrame: baseline to 6-month follow-up
measure: Quality of Life
timeFrame: baseline to 6-month follow-up
measure: Total Knee Injury and Osteoarthritis Outcome Score (KOOS) score
timeFrame: baseline to 6-month follow-up
measure: Pain intensity of the knee
timeFrame: baseline to 6-month follow-up
measure: Joint and cartilage structure
timeFrame: baseline to 6-month follow-up
measure: Intrafascial muscle tissue at the mid-thigh
timeFrame: baseline to 6-month follow-up
measure: Intermuscular adipose tissue at the mid-thigh
timeFrame: baseline to 6-month follow-up
measure: Intrafascial fat fraction at the mid-thigh
timeFrame: baseline to 6-month follow-up
measure: Visceral fat mass
timeFrame: baseline to 6-month follow-up
measure: C-reactive Protein (CRP)
timeFrame: baseline to 6-month follow-up
measure: Interleukin 1beta (IL1beta)
timeFrame: baseline to 6-month follow-up
measure: Matrix metalloprotease 3 (MMP-3)
timeFrame: baseline to 6-month follow-up
measure: Serum N-terminal pro-peptide of collagen IIA (PIINP)
timeFrame: baseline to 6-month follow-up
measure: Maximum strength of the hip-/leg extensors
timeFrame: baseline to 6-month follow-up
measure: Chair Rise Test
timeFrame: baseline to 6-month follow-up
Other outcomes:
measure: Drop-out rate
timeFrame: baseline to 6-month follow-up
measure: Attendance rate
timeFrame: baseline to 6-month follow-up
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics University of Erlangen-Nurnberg
Study officials:
affiliation: Institute of Radiology, University Hospital-Nürnberg
name: Stephanie Kast, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.