Transcranial Direct Current Stimulation in Conjunction With Individualized Physical Therapy for Individuals With Chronic Knee Pain

N/AActive Not RecruitingNCT06132412

University of Illinois at Chicago30 enrolled

Overview

Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (CNS). Majority of physical therapy (PT) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (\~66%) do not respond to this treatment approach. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the CNS and may better target central factors associated with chronic pain. Purpose: To determine if tDCS delivered to the primary motor cortex in conjunction with individualized PT will result in greater improvements in pain and function compared to sham tDCS with individualized PT in individuals with chronic knee pain. Methods: This study will be performed at outpatient PT clinics at the University of Illinois Hospital. Eligible participants will include patients with chronic knee pain (duration \> 3 months) who have not undergone surgery to this area and are scheduled to receive formal PT intervention. Subjects will be randomized to the active tDCS + PT group or sham tDCS + PT group and will receive the intervention for 8 sessions. Outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and Central Sensitization Inventory. Impact: The use of adjuvant therapies such as tDCS have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Interventions

transcranial direct current stimulationDEVICE

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that can have neuromodulatory effects on central nervous system structures, specifically the primary motor cortex (M1), and can potentially target maladaptive plasticity and nociplastic sources of pain. There is both anodal and cathodal tDCS, anodal stimulation increases excitability of the cortex whereas cathodal stimulation decreases excitability. At the synaptic level, anodal tDCS induces effects that mimic long term potentiation (LTP), while cathodal tDCS results in long term depression.

physical therapyOTHER

Participants will receive individualized and impairment-based physical therapy treatment for their knee pain. This treatment can involve manual therapy, exercise or balance training depending on their particular needs.

Outcomes

Primary Outcomes

Recruitment ratio

We will record the number of patients screened and enrolled in the study.

Time frame: through study completion, an average of 1 year

Pain (NPRS)

This will be measured subjectively using the Numeric Pain rating scale (NPRS). The PT or key research personnel with ask the participant their pain rating using a 0-10 scale. They will ask the current pain intensity rating, highest and lowest pain intensity rating in the past 2 week period.

Time frame: baseline, every follow-up session through study completion

Two-minute walk test (2MWT)

Distance walked, number of rest breaks and the assistive device(s) used during a 2MWT will be measured. From this test walking speed can also be calculated.