Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study)
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 39 - 70 |
| Updated: | 6/17/2018 |
| Start Date: | February 2016 |
| End Date: | January 20, 2017 |
Determining Efficacy of the Combined Application of Electrical Stimulated Antagonist Contraction During Walking With Sensory TENS for Increasing Strength and Decreasing Pain in Women With Frequent Knee Symptoms
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.
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.
Osteoarthritis of the knee (KOA) is the most common cause of disability not only in the
United States but also in Japan. KOA is associated with pain, quadriceps weakness, swelling,
instability, decline of range of motion, physical function, and quality of life (QOL) (1). In
particular, quadriceps weakness may contribute to incident symptomatic and progressive
disease (2, 3), cause functional limitations and disability (4) and increase the risk of
mortality (5). Both aerobic exercise and resistance exercise are recommended for the
treatment of people with knee osteoarthritis (KOA) (6). However, exercise at a moderate or
severe intensity is often a problem for people with knee pain or a history of knee injury.
Neuromuscular electrical stimulation (NMES) is widely used as a method to increase muscle
strength and improve physical function even at a low-moderate exercise intensity (7).
However, NMES effect may prove to be insufficient because the exercise intensity is
determined by the electrical stimulation endurance level of the user (7). On the other hand,
transcutaneous electrical stimulation, so-called transcutaneous electrical nerve stimulation
(TENS), is effective for pain relief (8). Knee pain independently reduced quadriceps strength
and activation (9). TENS restores inhibited quadriceps motor function (central and muscle
activation) through pain relief (10). Moreover the combined application of electrical
stimulation (ES) and volitional contractions (VC) is said to be more effective than ES or VC
alone (11). Therefore, a hybrid training system (HTS) that resists the motion of a
volitionally contracting agonist muscle using the force generated by its electrically
stimulated antagonist (NMES) was developed as a way to combine the application of electrical
stimulation and voluntary contraction (12). HTS is a method that eliminates the disadvantages
of both volitional exercise and NMES (13). It has been reported that HTS is a new training
technique that can increase both muscular strength and muscle mass (12, 13, 14, 15).
Recently, HTS is showing promise as a countermeasure for the musculoskeletal disuse of
astronauts because the HTS technique can generate exercise resistance within the body even if
there is no gravity (1). In addition, HTS can be utilized during many different types of
exercise (e.g. knee extension exercise, squat and hip flexion, walking exercise, and cycling
exercise) (17, 18). It seems to be more effective for improvement of muscle strength and
physical function to combine HTS with easy exercise (e.g. knee extension, walking, and
squats) for KOA patients.
The main purpose of exercise therapy for KOA is not only muscular strength improvement (the
quadriceps femoris muscle in particular) and but also pain relief (19, 20). Muscular strength
improvement protects joints and relieves nociceptive stimulation. However, exercise sometimes
increases pain. In addition to the pathological change in articular structures, changes in
central pain processing or central sensitization appear to be involved in KOA pain (19).
Murphy et al. reported that 36% of a heterogenous sample of patients with hip and KOA
demonstrated evidence of central sensitization (22). This finding has been incompletely
characterized, but it is necessary to consider central sensitization in the treatment of
patients with KOA. From a theoretical perspective, exercise has the potential to treat the
process of central sensitization: e.g. exercise activates brain-orchestrated endogenous
analgesia (23). An initial bout of high intensity eccentric exercise induces central
sensitization, but a repeated round of exercise facilitates inherent protective spinal
mechanisms (repeated bout effect) (24). Moreover, ipsilateral resistance exercise may
possibly prevent the central sensitization (25). Therefore, a time-contingent approach which
implies that the patient does not cease exercise bouts once local pain severity increases is
recommended (22). A few reports about the dysfunctional endogenous analgesia for patients
with musculoskeletal pain response to aerobic exercise were shown, but neither type of
aerobic exercise was able to activate endogenous analgesia (24). At present, there is no
report of an exercise method that is effective in central sensitization pain patients.
Brain-derived neurotrophic factor (BDNF) belongs to the neurotrophic family of growth
factors. The loss of BDNF usually leads to neurodegeneration in these motor centers and
eventually results in several severe motor diseases, such as amyotrophic lateral sclerosis,
spinocerebellar ataxias, Parkinson's disease, Huntington's disease, as well as vestibular
syndrome. These neurotrophic factors (e.g., decreasing brain-derived neurotrophic factor) are
promising new avenues for diminishing hyperexcitability of the CNS in central sensitization
pain patients (2). Da Graca-Tarrago et al. showed that a 30-minute electrical intramuscular
stimulation in osteoarthritis decreased pain, increased the local pain pressure threshold
(PPT), and decreased BDNF (27). Gajewska-Wozniak et al. reported that low-threshold
electrical stimulation of peripheral nerves to stimulate Ia afferent fibers (proprioceptive
signaling) might affect the expression of BDNF in rats (28). HTS is an exercise technique
that uses electrically eccentric muscle contraction. Yamaguchi et al. showed that the soleus
H-reflex increased after one HTS adversely in conventional resistance exercise (29). This
seems to indicate that HTS serves to activate Ia fibers. HTS may affect central sensitization
and relieve pain in KOA patients.
United States but also in Japan. KOA is associated with pain, quadriceps weakness, swelling,
instability, decline of range of motion, physical function, and quality of life (QOL) (1). In
particular, quadriceps weakness may contribute to incident symptomatic and progressive
disease (2, 3), cause functional limitations and disability (4) and increase the risk of
mortality (5). Both aerobic exercise and resistance exercise are recommended for the
treatment of people with knee osteoarthritis (KOA) (6). However, exercise at a moderate or
severe intensity is often a problem for people with knee pain or a history of knee injury.
Neuromuscular electrical stimulation (NMES) is widely used as a method to increase muscle
strength and improve physical function even at a low-moderate exercise intensity (7).
However, NMES effect may prove to be insufficient because the exercise intensity is
determined by the electrical stimulation endurance level of the user (7). On the other hand,
transcutaneous electrical stimulation, so-called transcutaneous electrical nerve stimulation
(TENS), is effective for pain relief (8). Knee pain independently reduced quadriceps strength
and activation (9). TENS restores inhibited quadriceps motor function (central and muscle
activation) through pain relief (10). Moreover the combined application of electrical
stimulation (ES) and volitional contractions (VC) is said to be more effective than ES or VC
alone (11). Therefore, a hybrid training system (HTS) that resists the motion of a
volitionally contracting agonist muscle using the force generated by its electrically
stimulated antagonist (NMES) was developed as a way to combine the application of electrical
stimulation and voluntary contraction (12). HTS is a method that eliminates the disadvantages
of both volitional exercise and NMES (13). It has been reported that HTS is a new training
technique that can increase both muscular strength and muscle mass (12, 13, 14, 15).
Recently, HTS is showing promise as a countermeasure for the musculoskeletal disuse of
astronauts because the HTS technique can generate exercise resistance within the body even if
there is no gravity (1). In addition, HTS can be utilized during many different types of
exercise (e.g. knee extension exercise, squat and hip flexion, walking exercise, and cycling
exercise) (17, 18). It seems to be more effective for improvement of muscle strength and
physical function to combine HTS with easy exercise (e.g. knee extension, walking, and
squats) for KOA patients.
The main purpose of exercise therapy for KOA is not only muscular strength improvement (the
quadriceps femoris muscle in particular) and but also pain relief (19, 20). Muscular strength
improvement protects joints and relieves nociceptive stimulation. However, exercise sometimes
increases pain. In addition to the pathological change in articular structures, changes in
central pain processing or central sensitization appear to be involved in KOA pain (19).
Murphy et al. reported that 36% of a heterogenous sample of patients with hip and KOA
demonstrated evidence of central sensitization (22). This finding has been incompletely
characterized, but it is necessary to consider central sensitization in the treatment of
patients with KOA. From a theoretical perspective, exercise has the potential to treat the
process of central sensitization: e.g. exercise activates brain-orchestrated endogenous
analgesia (23). An initial bout of high intensity eccentric exercise induces central
sensitization, but a repeated round of exercise facilitates inherent protective spinal
mechanisms (repeated bout effect) (24). Moreover, ipsilateral resistance exercise may
possibly prevent the central sensitization (25). Therefore, a time-contingent approach which
implies that the patient does not cease exercise bouts once local pain severity increases is
recommended (22). A few reports about the dysfunctional endogenous analgesia for patients
with musculoskeletal pain response to aerobic exercise were shown, but neither type of
aerobic exercise was able to activate endogenous analgesia (24). At present, there is no
report of an exercise method that is effective in central sensitization pain patients.
Brain-derived neurotrophic factor (BDNF) belongs to the neurotrophic family of growth
factors. The loss of BDNF usually leads to neurodegeneration in these motor centers and
eventually results in several severe motor diseases, such as amyotrophic lateral sclerosis,
spinocerebellar ataxias, Parkinson's disease, Huntington's disease, as well as vestibular
syndrome. These neurotrophic factors (e.g., decreasing brain-derived neurotrophic factor) are
promising new avenues for diminishing hyperexcitability of the CNS in central sensitization
pain patients (2). Da Graca-Tarrago et al. showed that a 30-minute electrical intramuscular
stimulation in osteoarthritis decreased pain, increased the local pain pressure threshold
(PPT), and decreased BDNF (27). Gajewska-Wozniak et al. reported that low-threshold
electrical stimulation of peripheral nerves to stimulate Ia afferent fibers (proprioceptive
signaling) might affect the expression of BDNF in rats (28). HTS is an exercise technique
that uses electrically eccentric muscle contraction. Yamaguchi et al. showed that the soleus
H-reflex increased after one HTS adversely in conventional resistance exercise (29). This
seems to indicate that HTS serves to activate Ia fibers. HTS may affect central sensitization
and relieve pain in KOA patients.
Inclusion Criteria:
1. Female
2. Age 40-70 years
3. Knee symptoms (pain, aching, or stiffness) on most of the last 30 days (categorically
defined)
4. Body Mass Index (BMI) 30-45kg/m2
Exclusion Criteria:
1. Resistance training at any time in the last 3 months prior to the study
2. Bilateral knee replacement
3. Lower limb amputation
4. Lower limb surgery in the last 6 months that affects walking ability or ability to
exercise
5. Back or hip problems that affect walking ability or ability to exercise
6. Unable to walk without a cane or walker
7. Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or
polymyalgia rheumatica
8. Multiple sclerosis or other neurodegenerative disorder
9. Known neuropathy
10. Currently being treated with insulin for diabetes
11. Currently being treated for cancer or having untreated cancer
12. Terminal illness (cannot be cured or adequately treated and there is a reasonable
expectation of death in the near future)
13. Peripheral Vascular Disease
14. History of myocardial infarction or stroke in the last year
15. Chest pain during exercise or at rest
16. Use of supplemental oxygen
17. Inability to follow protocol (e.g. lack of ability to attend visits or understand
instructions)
18. Staff concern for participant health (such as history of dizziness/faintness or
current restrictions on activity)
19. Unable to attend more than 2 days within any 1 week or unable to attend 4 or more
sessions during the study
20. Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or
other implanted electrical device.
21. Dermatitis or skin sensitivity to tape used in the study.
22. Pregnancy
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Neil A Segal, MD
Phone: 913-588-6777
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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