Stimulation of Peripheral Afferents to Reduce Muscle Inhibition at the Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorNortheastern University
About this trial
Knee osteoarthritis is a leading cause of disability, and the muscle weakness that limits walking in this population arises not only from the joint itself but from afferent signals that inhibit motor drive to the thigh muscle, which is why exercise alone so often produces incomplete recovery. This project examines whether brief, non-invasive electrical stimulation of a nerve behind the knee can reduce inhibition and restore muscle coordination while walking in adults with knee osteoarthritis. Establishing this effect would identify a modifiable neural target that current rehabilitation does not address, with the potential to improve physical function and independence for the millions of adults living with this condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>45 years old
Able to speak and understand English
Unilateral or bilateral knee OA, per NICE criteria
Age 45+ AND
Disqualifiers
History of lower extremity surgery.
BMI > 40kg/m²
Received an intra-articular knee joint injection within the last 3 months.
Currently pregnant.
Trial design
Design model
Crossover
Treatments tested in this trial
Peripheral Electrical Stimulation (PES)
Other interventionParticipants will receive a single session intervention of single pulses of electrical stimulation to the tibial nerve at a below motor threshold intensity. These pulses will be delivered with a pulse width of 1000 microseconds, delivered at 20 Hz frequency. This intervention will last approximately 30 minutes and deliver 24,000 stimulation pulses.
Paired Pulse Electrical Stimulation (ppES)
Other interventionParticipants will receive a single session intervention of pairs of electrical stimulation pulses delivered to the tibial nerve. These pairs will use pulses of 1000 microseconds duration, separated by a 5 millisecond interstimulus interval, delivered at a frequency of 10Hz. Participants will receive 12,000 stimulation pairs during an intervention lasting approximately 30 minutes.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Paired-Pulse Electrical Stimulation InterventionExperimental treatment 1 intervention
Group B: Peripheral Electrical StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Short-latency Afferent Inhibition Ratio
Measuring change in short-latency afferent inhibition (SAI) ratio of the motor cortex controlling quadriceps muscle excitability across timepoints
Time frame
Before, immediately after, and 30 minutes after intervention at each study session2
Change in Muscle Co-Activation Percentage During Treadmill Walking
Measuring change in co-activation percentage of quadriceps and hamstring muscle pairs during treadmill walking across timepoints
Time frame
Before, immediately after, and 30 minutes after intervention at each study sessionSecondary outcomes
1
Change in Somatosensory Evoked Potentials Amplitude
Measuring change in somatosensory evoked potentials (SEPs) amplitude measured in the sensory cortex in response to peripheral electrical stimulation across timepoints
Time frame
Before, immediately after, and 30 minutes after intervention at each study session2
Change in Dynamic Motor Control Index of Gait During Treadmill Walking
Measuring change in the organization of motor control strategies, in terms of dynamic motor control index, during treadmill walking across timepoints
Time frame
Before, immediately after, and 30 minutes after intervention at each study sessionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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