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

NCT06132412 | Active Not Recruiting

• 1 other identifier: 2023-1323
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (3)

• Recruitment ratio

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

  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.

  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.

  baseline, at final intervention session

Secondary Outcomes (9)

• Pressure pain threshold (PPT)

  baseline, at final intervention session

• central sensitization inventory (CSI)

  baseline, at final intervention session

• Lower extremity functional scale (LEFS)

  baseline, at final intervention session

• Patient specific functional scale (PSFS)

  baseline, at final intervention session

• Five time sit to stand (5STS)

  baseline, at final intervention session

Study Arms (2)

active tDCS+PT

EXPERIMENTAL

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.

Device: transcranial direct current stimulation; Other: physical therapy

sham tDCS+PT

SHAM COMPARATOR

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.

Device: transcranial direct current stimulation; Other: physical therapy

Interventions

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.

Also known as: tDCS

active tDCS+PT; sham tDCS+PT

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.

Also known as: PT

active tDCS+PT; sham tDCS+PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Hospital

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Physical Therapy

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 15, 2023
• Study Start: June 6, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)