Whole-Body Electromyostimulation and Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Whole-Body Electromyostimulation
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WB-EMS group<br>WB-EMS application | Other: Whole-Body Electromyostimulation<br>* 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.<br>|
| Active Comparator: Control<br>Standardised physiotherapy (six sessions) | Other: Physiotherapy<br>* Six standardised physiotherapy sessions (20 min each)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self rated symptoms | Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension self-rated symptoms in the WB-EMS- compared to changes in the control group. KOOS score for self related symptoms vary from 1 (never) to 5 (always). | baseline to 6-month follow-up | 
| Knee stiffness | Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension knee stiffness in the WB-EMS- compared to changes in the control group. KOOS score for knee stiffness vary from 1 (no problems) to 5 (very hard). | baseline to 6-month follow-up | 
| Function in daily living | Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension function in daily living in the WB-EMS- compared to changes in the control group. KOOS score for function in daily living vary from 1 (no problems) to 5 (very serious problems). | baseline to 6-month follow-up | 
| Function in sports and recreational activities | Changes in Knee Injury and Osteoarthritis Outcome Score Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension function in sports and recreational activities in the WB-EMS- compared to changes in the control group. KOOS score for function in sports and recreational activities vary from 1 (no problems) to 5 (very serious problems). | baseline to 6-month follow-up | 
| Quality of Life | Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension quality of life in the WB-EMS- compared to changes in the control group. KOOS score for quality of life vary from 1 (never/no problems) to 5 (always/very serious problems). | baseline to 6-month follow-up | 
| Total Knee Injury and Osteoarthritis Outcome Score (KOOS) score | Changes in total KOOS-score in the WB-EMS- compared to changes in the control group. Average total KOOS score vary from 1 (never/no problems) to 5 (always/very serious problems). | baseline to 6-month follow-up | 
| Pain intensity of the knee | Changes in pain intensity of the knee as determined by a 7-day knee pain protocol (applying the NRS 0-10 scale) in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Joint and cartilage structure | Changes in joint and cartilage structure as determined by the MRI Osteoarthritis Knee Score (MOAKS) in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Intrafascial muscle tissue at the mid-thigh | Changes in volume adjusted intrafascial muscle tissue volume (MT) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Intermuscular adipose tissue at the mid-thigh | Changes in volume adjusted intermuscular adipose tissue (IMAT) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Intrafascial fat fraction at the mid-thigh | Changes in volume adjusted intrafascial fat fraction (IFFF) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Visceral fat mass | Changes in visceral fat mass as determined by determined by MRI in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| C-reactive Protein (CRP) | Changes in CRP-levels in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Interleukin 1beta (IL1beta) | Changes in IL1beta-levels in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Matrix metalloprotease 3 (MMP-3) | Changes in MMP-3 levels in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Serum N-terminal pro-peptide of collagen IIA (PIINP) | Changes in PIINP levels in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Maximum strength of the hip-/leg extensors | Changes in maximum strength of the hip-/leg extensors as determined by an isokinetic leg press in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up | 
| Chair Rise Test | Changes in the 30-second Chair Rise Test in the WB-EMS- compared to changes in the control group. | baseline to 6-month follow-up |