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

University of Illinois

Status: Enrolling

Conditions: Knee Pain Chronic

Treatments: Other: physical therapy; Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06132412

2023-1323

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >/= 18 years old
• Knee pain
• Knee pain duration >/= 3 months

Exclusion criteria

General exclusion criteria

• History of surgery on affected knee
• Pregnant

tDCS exclusion criteria

• Skin hypersensitivity
• History of contact dermatitis
• Any other skin or scalp condition that could be aggravated by tDCS
• Previous adverse reactions to tDCS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

active tDCS+PT

Experimental group

Description:

For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm\^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The intensity will be set at 2mA for the active tDCS group, following a 30 second ramp-up time. The participants in the active tDCS group will undergo 20 minutes of tDCS treatment prior to receiving individualized PT intervention.

Treatment:

Device: transcranial direct current stimulation

Other: physical therapy

sham tDCS+PT

Sham Comparator group

Description:

For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT tDCS device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm\^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The participants in the sham tDCS group will undergo 20 minutes of sham tDCS treatment prior to receiving individualized PT intervention.

Treatment:

Device: transcranial direct current stimulation

Other: physical therapy