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NCT07291791

tDCS for Pain Modulation in Knee Osteoarthritis

Sponsor: Suez Canal University

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Neuromodulatory Effects of Transcranial Direct Current Stimulation on Pain in Knee Osteoarthritis Patients: A Double Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2025-12-20

Completion Date

2026-06-01

Last Updated

2025-12-24

Healthy Volunteers

Conditions

Knee Osteoarthritis

Interventions

DEVICE

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.

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).

Locations (1)

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

Ismailia, Egypt