Clinical trial NCT06132412: Transcranial Direct Current Stimulation in Conjunction with Individualized Physical Therapy for Individuals with Chronic Knee Pain
Official title: Transcranial Direct Current Stimulation in Conjunction with Individualized Physical Therapy for Individuals with Chronic Knee Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Pain Chronic
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment ratio
timeFrame: through study completion, an average of 1 year
measure: Pain (NPRS)
timeFrame: baseline, every follow-up session through study completion
measure: Two-minute walk test (2MWT)
timeFrame: baseline, at final intervention session
Secondary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: baseline, at final intervention session
measure: central sensitization inventory (CSI)
timeFrame: baseline, at final intervention session
measure: Lower extremity functional scale (LEFS)
timeFrame: baseline, at final intervention session
measure: Patient specific functional scale (PSFS)
timeFrame: baseline, at final intervention session
measure: Five time sit to stand (5STS)
timeFrame: baseline, at final intervention session
measure: knee range of motion (ROM)
timeFrame: baseline, at final intervention session
measure: quadriceps strength
timeFrame: baseline, at final intervention session
measure: Treatment adherence
timeFrame: through study completion, an average of 1 year
measure: tDCS satisfaction
timeFrame: at final intervention session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
Study officials:
References: