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

Completed · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02730598

Run by

University of Kansas Medical Center

People needed

28

Starts

2016-02-01

Expected to finish

2017-01-20

Last updated by the study team

2018-06-15

Who can join

Age: 39 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Age 40-70 years
• Knee symptoms (pain, aching, or stiffness) on most of the last 30 days (categorically defined)
• Body Mass Index (BMI) 30-45kg/m2

You may not qualify if…

• Resistance training at any time in the last 3 months prior to the study
• Bilateral knee replacement
• Lower limb amputation
• Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
• Back or hip problems that affect walking ability or ability to exercise
• Unable to walk without a cane or walker
• Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
• Multiple sclerosis or other neurodegenerative disorder
• Known neuropathy
• Currently being treated with insulin for diabetes
• Currently being treated for cancer or having untreated cancer
• Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
• Peripheral Vascular Disease
• History of myocardial infarction or stroke in the last year
• Chest pain during exercise or at rest
• Use of supplemental oxygen
• Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
• Staff concern for participant health (such as history of dizziness/faintness or current restrictions on activity)
• Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study
• Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or other implanted electrical device.
• Dermatitis or skin sensitivity to tape used in the study.
• Pregnancy

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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