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The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.
We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention.
Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effective dose | Experimental | • The effective dose of TENS will be set at an intensity to elicit slight contractions in each target muscle, as we have done previously. It will be delivered as 5-Hz bursts (7 pulses at 100 Hz/burst) and applied during the light exercises. The applied current (<20 mA) will differ slightly for each of the four muscle groups and will be determined while the person is standing. The current will be set at the beginning of every treatment session for both groups of participants. |
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| Sham dose | Sham Comparator | • The current intensity for the sham dose will be set at sensory threshold, which will be less than that used for the effective dose. After beginning each exercise set, the current for the sham dose will decay to 0 mA within 30 s. In a preliminary study that included a sham dose of TENS, we found that only two of the experienced dancers in the sham group detected the gradual decline in TENS current from its initial value slightly above motor threshold when performing prescribed exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation | Device | Electrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Questionnaire scores - PROMIS Fatigue (MS) 8a | Changes at Weeks 4, 7, and 11 |
| Walking limitations | Questionnaire scores - MS Walking Scale-12 | Changes at Weeks 4, 7, and 11 |
| Walking endurance | 6-min walk test in meters | Changes at Weeks 4, 7, and 11 |
| Mobility | Assessment of static and dynamic balance with Mobility Lab, APDM Inc | Changes at Weeks 4, 7, and 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire | Questionnaire scores | Changes at Weeks 4, 7, and 11 |
| Muscle strength | Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roger Enoka, PhD | Contact | 3034927232 | enoka@colorado.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Recruiting | Boulder | Colorado | 80309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34583577 | Background | Enoka RM, Almuklass AM, Alenazy M, Alvarez E, Duchateau J. Distinguishing between Fatigue and Fatigability in Multiple Sclerosis. Neurorehabil Neural Repair. 2021 Nov;35(11):960-973. doi: 10.1177/15459683211046257. Epub 2021 Sep 28. | |
| 29366377 | Result | Almuklass AM, Davis L, Hamilton LD, Hebert JR, Alvarez E, Enoka RM. Pulse Width Does Not Influence the Gains Achieved With Neuromuscular Electrical Stimulation in People With Multiple Sclerosis: Double-Blind, Randomized Trial. Neurorehabil Neural Repair. 2018 Jan;32(1):84-93. doi: 10.1177/1545968317753681. Epub 2018 Jan 24. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Changes at Weeks 4, 7, and 11 |
| 31715503 | Result | Almuklass AM, Capobianco RA, Feeney DF, Alvarez E, Enoka RM. Sensory nerve stimulation causes an immediate improvement in motor function of persons with multiple sclerosis: A pilot study. Mult Scler Relat Disord. 2020 Feb;38:101508. doi: 10.1016/j.msard.2019.101508. Epub 2019 Nov 6. |
| 34710779 | Result | Alenazy M, Daneshgar Asl S, Petrigna L, Feka K, Alvarez E, Almuklass AM, Enoka RM. Treatment with electrical stimulation of sensory nerves improves motor function and disability status in persons with multiple sclerosis: A pilot study. J Electromyogr Kinesiol. 2021 Dec;61:102607. doi: 10.1016/j.jelekin.2021.102607. Epub 2021 Oct 13. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |