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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>/= 18 years old

• Knee pain

• Knee pain duration \>/= 3 months

Locations
United States
Illinois
University of Illinois Hospital
RECRUITING
Chicago
Contact Information
Primary
Mariah Balinski
balinsk1@uic.edu
6308634273
Backup
Sangeetha Madhavan
smadhava@uic.edu
(312) 355-2517
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Experimental: active tDCS+PT
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.
Sham_comparator: sham tDCS+PT
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.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov