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

NCT02730598 | Completed Results

• 1 other identifier: STUDY00003435
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Knee Extensor Strength Assessed by Isokinetic Dynamometer.

  Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.

  Baseline and 12-week follow-up

Secondary Outcomes (7)

• Change in Knee Flexor Strength Assessed by Isokinetic Dynamometer

  Baseline and 12-week follow-up

• Change in Knee Pain Assessed by a Visual Analog Scale (VAS)

  Baseline and 12-week follow-up

• Change in Knee Pain Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline and 12-week follow-up

• Change in Quality of Life (QOL) Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline and 12-week follow-up

• Change in 20-meter Walk Time.

  Baseline and 12-week follow-up

Study Arms (2)

Hybrid Training System (HTS)

EXPERIMENTAL

HTS stimulation while walking at a comfortable pace for 30 minutes.

Device: Hybrid Training System (HTS)

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

Sensory TENS while walking at a comfortable pace for 30 minutes.

Device: Sensory TENS

Interventions

Hybrid Training System (HTS) DEVICE

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.

Hybrid Training System (HTS)

Sensory TENS DEVICE

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.

Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 39 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Kurume University: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (31)

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  BACKGROUND

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• Matsuse H, Segal NA, Rabe KG, Shiba N. Effect of Neuromuscular Electrical Stimulation During Walking on Pain Sensitivity in Women With Obesity With Knee Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Sep;103(9):1707-1714. doi: 10.1016/j.apmr.2022.01.157. Epub 2022 Mar 23.

  PMID: 35337843 DERIVED

• Matsuse H, Segal NA, Rabe KG, Shiba N. The Effect of Neuromuscular Electrical Stimulation During Walking on Muscle Strength and Knee Pain in Obese Women With Knee Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jan;99(1):56-64. doi: 10.1097/PHM.0000000000001319.

  PMID: 31592880 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The number of participants was insufficient to detect a statistically significant improvement in knee pain.

Results Point of Contact

• Title: Neil Segal
• Organization: University of Kansas Medical Center

segal-research@kumc.edu

(913) 945-8985

Study Officials

• Neil A Segal, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Faculty Physiatrist

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 6, 2016
• Study Start: February 1, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)