Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study)

Summary

Osteoarthritis of the knee (KOA) is the most common cause of disability in older adults. Osteoarthritis involves a loss of cartilage, which acts like a cushion between the bones as well as changes in the bones of joints. Once the joint cartilage is gone, the body does not produce new cartilage. Joint damage can contribute to pain. Currently, treatment for pain associated with knee osteoarthritis includes exercise. However, exercise at a medium- to high-intensity level can be problematic for people with knee pain. Because exercise is a common treatment for knee pain but many people experience pain during exercise, researchers hope to find a safer and more effective exercise method to strengthen the muscles around the knee.

Both aerobic exercise and resistance exercise are recommended for the treatment of people with knee pain. However, pain can be a barrier to participating in exercise at a moderate or vigorous intensity. Electrical stimulation of muscles holds potential to allow effective exercise to be completed at tolerable intensities. Transcutaneous electrical nerve stimulation (TENS) is the use of very low electric currents produced by a device to stimulate the nerves, to treat pain. Neuromuscular electrical stimulation (NMES) uses low electrical current to cause muscles to contract.

By doing this study, the investigators hope to learn if a hybrid training system (HTS), using a combination of NMES and walking, is effective in strengthening muscles in people with knee pain, aching or stiffness.

In this pilot study, the investigators will use walking with TENS as conventional exercise.

Randomized controlled trial will be conducted to compare the effect of walking augmented by HTS with walking without HTS. The investigators will evaluate the relative advantages of training that combines HTS with conventional walking exercise on the improvement of muscle strength, physical function, and pain relief in obese women with frequent knee symptoms.

Study Hypotheses: Compared with walking with sensory TENS, walking with HTS will:

* 1 increase quadriceps muscle strength.
* 2 decrease knee pain.

Exploratory Hypotheses:

* 3 improve physical function.
* 4 increase PPT (improve central sensitization).
* 5 improve self-reported quality of life.

Conditions

• Knee Osteoarthritis

Interventions

DEVICE

Hybrid Training System (HTS)

Electrodes (15 cm x 6 cm) will be placed over the quadriceps and electrodes (11 cm x 6 cm) (Sekisui Plastics Co., Tokyo, Japan) will be placed over the hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5,000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor (EWTS9PD, Home Appliances Development Center Corporate Engineering Division, Appliances Company Panasonic Corporation 2-3-1-2 Noji-higashi,Kusatsu City, Shiga, Japan) is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to \~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.

DEVICE

Sensory TENS

The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.

Sponsors & Collaborators

• Kurume University

  collaborator OTHER

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• Neil A Segal, MD · University of Kansas Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

39 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2017-01-20

Completion

2017-01-20

Countries

• United States

Study Locations