Transcranial Direct Current Stimulation in Conjunction with Individualized Physical Therapy for Individuals with Chronic Knee Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Pain Chronic
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Recruitment ratio
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Sangeetha Madhavan
Professor in Department of Physical Therapy
University of Illinois at Chicago
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
- •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
Outcomes
Primary Outcomes
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.
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.
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
- Patient specific functional scale (PSFS)(baseline, at final intervention session)
- quadriceps strength(baseline, at final intervention session)
- 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)
- Five time sit to stand (5STS)(baseline, at final intervention session)
- Treatment adherence(through study completion, an average of 1 year)
- tDCS satisfaction(at final intervention session)
- knee range of motion (ROM)(baseline, at final intervention session)