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Whole-Body Electromyostimulation and Knee Osteoarthritis (EMSOAT)

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Whole-Body Electromyostimulation
Physiotherapy
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Medical Physics University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WB-EMS group

Control

Arm Description

WB-EMS application

Standardised physiotherapy (six sessions)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
C-reactive Protein (CRP)
Changes in CRP-levels in the WB-EMS- compared to changes in the control group.
Interleukin 1beta (IL1beta)
Changes in IL1beta-levels in the WB-EMS- compared to changes in the control group.
Matrix metalloprotease 3 (MMP-3)
Changes in MMP-3 levels in the WB-EMS- compared to changes in the control group.
Serum N-terminal pro-peptide of collagen IIA (PIINP)
Changes in PIINP levels in the WB-EMS- compared to changes in the control group.
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.
Chair Rise Test
Changes in the 30-second Chair Rise Test in the WB-EMS- compared to changes in the control group.

Full Information

First Posted
January 2, 2023
Last Updated
January 4, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05672264
Brief Title
Whole-Body Electromyostimulation and Knee Osteoarthritis
Acronym
EMSOAT
Official Title
Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WB-EMS group
Arm Type
Experimental
Arm Description
WB-EMS application
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standardised physiotherapy (six sessions)
Intervention Type
Other
Intervention Name(s)
Whole-Body Electromyostimulation
Intervention Description
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
Intervention Name(s)
Physiotherapy
Intervention Description
Six standardised physiotherapy sessions (20 min each)
Primary Outcome Measure Information:
Title
Knee pain
Description
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)
Time Frame
baseline to 6 month follow up
Secondary Outcome Measure Information:
Title
Self rated symptoms
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Knee stiffness
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Function in daily living
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Function in sports and recreational activities
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Quality of Life
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Total Knee Injury and Osteoarthritis Outcome Score (KOOS) score
Description
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).
Time Frame
baseline to 6-month follow-up
Title
Pain intensity of the knee
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Joint and cartilage structure
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Intrafascial muscle tissue at the mid-thigh
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Intermuscular adipose tissue at the mid-thigh
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Intrafascial fat fraction at the mid-thigh
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Visceral fat mass
Description
Changes in visceral fat mass as determined by determined by MRI in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Title
C-reactive Protein (CRP)
Description
Changes in CRP-levels in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Title
Interleukin 1beta (IL1beta)
Description
Changes in IL1beta-levels in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Title
Matrix metalloprotease 3 (MMP-3)
Description
Changes in MMP-3 levels in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Title
Serum N-terminal pro-peptide of collagen IIA (PIINP)
Description
Changes in PIINP levels in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Title
Maximum strength of the hip-/leg extensors
Description
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.
Time Frame
baseline to 6-month follow-up
Title
Chair Rise Test
Description
Changes in the 30-second Chair Rise Test in the WB-EMS- compared to changes in the control group.
Time Frame
baseline to 6-month follow-up
Other Pre-specified Outcome Measures:
Title
Drop-out rate
Description
Drop-out rate of the WB-EMS- compared to the control group.
Time Frame
baseline to 6-month follow-up
Title
Attendance rate
Description
Attendance rate in the WB-EMS group (in percent of maximum sessions)
Time Frame
baseline to 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Kast, MSc
Organizational Affiliation
Institute of Radiology, University Hospital-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Physics University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36111142
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.
Results Reference
result
PubMed Identifier
35812334
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.
Results Reference
result
PubMed Identifier
33716787
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.
Results Reference
result

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Whole-Body Electromyostimulation and Knee Osteoarthritis

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