tDCS for Pain Modulation in Knee Osteoarthritis

NCT ID: NCT07291791

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-06-01

Brief Summary

Knee osteoarthritis (KOA) is a common condition that causes long-lasting knee pain and difficulty with daily activities. Many patients have pain that is stronger than expected from joint changes because the nervous system becomes more sensitive to pain. Transcranial direct current stimulation (tDCS) is a non-invasive technique that uses a small electrical current applied to the scalp to help reduce pain sensitivity.

This study will test whether active tDCS over the primary motor cortex can reduce pain and improve function in people with knee osteoarthritis. A total of 102 participants will be randomly assigned to receive either active tDCS or sham (placebo) stimulation. All participants will receive 15 sessions over three weeks. We will measure pain intensity, pain sensitivity, physical function, depression, cognition, and quality of life before the treatment, after the 3-week treatment program, and again at the 1-month follow-up.

Detailed Description

Knee osteoarthritis (KOA) is a major cause of chronic pain, disability, and reduced quality of life. In many patients, the severity of pain exceeds structural joint damage due to peripheral and central sensitization, including impaired conditioned pain modulation (CPM). Such dysfunction in descending inhibitory pathways contributes to pain amplification and poor response to standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique capable of modulating cortical excitability, enhancing descending inhibition, and potentially restoring altered pain processing mechanisms.

This randomized, assessor- and participant-blinded, sham-controlled clinical trial will investigate the neuromodulatory effects of anodal primary motor cortex (M1) tDCS in patients with KOA exhibiting impaired CPM. A total of 102 participants who meet eligibility criteria will be randomly assigned (1:1) to receive either active anodal M1-tDCS (2 mA, 20 minutes per session) or sham stimulation, using identical electrode placement and brief initial stimulation to maintain blinding. Both groups will receive 15 sessions administered over three consecutive weeks.

Assessments will be conducted at baseline, immediately after the intervention, and at 1-month follow-up. Primary outcomes include changes in pain intensity measured by the Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI). Secondary outcomes include peripheral and central sensitization measures-Pressure Pain Threshold (PPT), Conditioned Pain Modulation (CPM), Central Sensitization Inventory (CSI), and PainDETECT-as well as functional outcomes assessed using the WOMAC index, Timed Up and Go (TUG) test, and One-Leg Stance. Additional outcomes include depressive symptoms (Beck Depression Inventory, BDI), cognitive function (Mini-Mental State Examination, MMSE), and health-related quality of life (SF-12).

This study aims to provide a comprehensive evaluation of the analgesic and neuromodulatory effects of tDCS in KOA, and to clarify its impact on pain modulation, pain sensitization, physical function, depression, cognition, and overall quality of life.

Conditions

Knee Osteoarthritis

Keywords

Knee Pain; Osteoarthritis; tDCS; Neuromodulation; Central Sensitization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS

Participants in this arm (active tDCS group) will receive active anodal transcranial direct current stimulation (tDCS) applied over the primary motor cortex (M1). Stimulation will be delivered at 2 mA for 20 minutes per session, for a total of 15 sessions (five sessions per week for three consecutive weeks). Electrode placement follows standardized M1 montage protocols.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies low-intensity direct current to modulate cortical excitability. In this trial, stimulation is delivered over the primary motor cortex (M1) using saline-soaked sponge electrodes. For the active arm, anodal tDCS is applied at 2 mA for 20 minutes per session, for 15 sessions over three weeks. For the sham arm, the same electrode placement and device settings are used, but the current is ramped down after approximately 30 seconds to mimic the sensation of active stimulation without producing neuromodulatory effects.

Sham tDCS

Participants in this arm (sham tDCS group) will receive sham tDCS using identical electrode placement and device settings as the active tDCS arm. The current will be applied for approximately 30 seconds and then gradually ramped down to zero to mimic the initial tingling sensation of active stimulation while delivering no effective stimulation. A total of 15 sessions will be administered over three weeks.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies low-intensity direct current to modulate cortical excitability. In this trial, stimulation is delivered over the primary motor cortex (M1) using saline-soaked sponge electrodes. For the active arm, anodal tDCS is applied at 2 mA for 20 minutes per session, for 15 sessions over three weeks. For the sham arm, the same electrode placement and device settings are used, but the current is ramped down after approximately 30 seconds to mimic the sensation of active stimulation without producing neuromodulatory effects.

Interventions

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies low-intensity direct current to modulate cortical excitability. In this trial, stimulation is delivered over the primary motor cortex (M1) using saline-soaked sponge electrodes. For the active arm, anodal tDCS is applied at 2 mA for 20 minutes per session, for 15 sessions over three weeks. For the sham arm, the same electrode placement and device settings are used, but the current is ramped down after approximately 30 seconds to mimic the sensation of active stimulation without producing neuromodulatory effects.

Intervention Type: DEVICE

Other Intervention Names

tDCS

Eligibility Criteria

Inclusion Criteria

• Diagnosis of knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) clinical criteria.
• Adults of both sexes aged 35 years or older.
• Clinical knee pain persisting for at least 3 months.
• Average knee pain intensity ≥ 4/10 on the Numerical Rating Scale (NRS; 0-10) during the previous 24 hours, with one dominant affected knee.
• Central sensitization phenotype: impaired conditioned pain modulation (CPM), defined as no change or a reduction in pressure pain threshold (PPT) after the conditioning stimulus, corresponding to a PPT ratio ≥ 1 (pre-to-post stimulus).
• Prior pharmacological pain management with NSAIDs and/or SNRIs discontinued due to adverse effects, intolerance, or contraindications, and able to complete the required washout period (2 weeks for NSAIDs and 4 weeks for SNRIs) before baseline assessment.
• Able and willing to provide written informed consent and comply with study procedures.

Exclusion Criteria

Participants will be excluded if they have any condition that could affect cortical excitability, confound outcome measures, or interfere with tDCS safety, including:

• Other chronic pain conditions associated with central sensitization (e.g., fibromyalgia).
• Inflammatory arthropathies (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus).
• Neuropathic pain syndromes (e.g., lumbar or cervical radiculopathy).
• Any clinically significant or unstable systemic disease (cardiovascular, hepatic, renal, or metabolic disorders).
• Pregnancy or active malignancy.
• Neurological or psychiatric disorders including epilepsy, history of syncope, traumatic brain injury with residual deficit, or major depressive disorder.
• Current participation in physiotherapy, electrotherapy, or exercise rehabilitation programs.
• Metallic implants or implanted electrical devices (e.g., pacemakers, cochlear implants, deep brain stimulators).
• Cognitive impairment interfering with understanding instructions or providing informed consent.
• Dermatological contraindications at stimulation or testing sites (e.g., open wounds, infection, irritation).
• History of alcohol or substance abuse, or current use of centrally acting medications that alter cortical excitability (e.g., benzodiazepines).

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nourhan E. Elkaraly, M.B.B.Ch.2015; MSc (PMRR)2020

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University, Faculty of Medicine

Aziza S. Omar, M.D.

Role: STUDY_CHAIR

Suez Canal University, Faculty of Medicine

Ahmed F. Genedy, M.D.

Role: STUDY_CHAIR

Faculty of Medicine, Armed Forces Military Academy

Samah I. Nasef, M.D.

Role: STUDY_CHAIR

Suez Canal University, Faculty of Medicine

Maha E. Ibrahim, M.D.

Role: STUDY_CHAIR

Suez Canal University, Faculty of Medicine

Locations

Suez Canal University Hospitals - Physical Medicine, Rheumatology and Rehabilitation Outpatient Clinics

Ismailia, , Egypt

Countries

Egypt

Central Contacts

Nourhan E. Elkaraly, M.B.B.Ch. 2015; MSc (PMRR)2020

Role: CONTACT

Phone: +20-100-310-9805

Email: dr.nourhanelkaraly@yahoo.com

Facility Contacts

Nourhan E. Elkaraly, MSc (PMRR)

Role: primary

Other Identifiers

tDCS121225

Identifier Type: -

Identifier Source: org_study_id