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NCT Number: NCT06132412

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Pain Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Hospital

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Other names: tDCS

Physical Therapy

Other

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.

Other names: PT

Primary outcomes

  1. Recruitment ratio

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

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

  2. Pain (NPRS)

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

    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.

  3. Two-minute walk test (2MWT)

    Time frame: baseline, at final intervention session

    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.

Secondary outcomes

  1. Pressure pain threshold (PPT)

    Time frame: baseline, at final intervention session

    PPT will be obtained with an electronic pressure algometer and the pressure will be recorded in kPa to allow for comparison to norms

  2. central sensitization inventory (CSI)

    Time frame: baseline, at final intervention session

    CSI is a self-report questionnaire that will be used as a secondary outcome to identify patients that may have symptoms related to central sensitization or nociplastic pain which may allow for subgroup analysis of data to occur

  3. Lower extremity functional scale (LEFS)

    Time frame: baseline, at final intervention session

    self-report questionnaire where participants will rate the difficulty level they have with various daily mobility tasks

  4. Patient specific functional scale (PSFS)

    Time frame: baseline, at final intervention session

    The PSFS is a self-report outcome measure that is individualized to the patient's specific activity impairments. The participant will choose 3 activities that are limited or difficult for them due to their knee pain and then will rate the level of difficulty of each task. On this scale, 0 means that the participant is unable to complete the activity at all and 10 means that the participant is able to perform the activity at the same level as before the injury or problem.

  5. Five time sit to stand (5STS)

    Time frame: baseline, at final intervention session

    5STS will time the amount of time it takes for the participant to stand up and sit down five times as fast as they can from a standard chair without the use of their upper extremities if possible. If participants require upper extremity support to complete the task then this will be documented

  6. knee range of motion (ROM)

    Time frame: baseline, at final intervention session

    ): Knee flexion and extension ROM will be measured with the patient in a supine position if possible. If participants have knee ROM measured in a position other than supine this will be documented.

  7. quadriceps strength

    Time frame: baseline, at final intervention session

    Quadriceps strength will be assessed using a hand-held dynamometer with the patient in a seated position

  8. Treatment adherence

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

    Adherence to tDCS and physical therapy treatment will also be recorded.

  9. tDCS satisfaction

    Time frame: at final intervention session

    Participants and clinicians involved in the study will also complete a survey following completion of the study regarding their impressions (positive and negative) regarding tDCS.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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