Clinical trial NCT04902274: Effectiveness of Transcranial Direct Current Stimulation (tDCS).
Official title: Effectiveness of Transcranial Direct Current Stimulation (tDCS) in Musculoskeletal Rehabilitation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ankle Sprains
Musculoskeletal Injury
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2021-05-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.


Eligibility criteria: Inclusion Criteria:

1. Age 18-40
2. Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain

Exclusion Criteria:

1. Self-Reported Pregnancy
2. Being treated for and on medication for a mental health diagnosis
3. Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
4. Open wound or dermatologic lesion on the head or region of application
5. Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
6. Epilepsy or history of seizures
7. Participants who are not fluent in English

Primary outcomes:
measure: Composite Pain Rating
timeFrame: Change from Baseline to 4-weeks
measure: Composite Pain Rating
timeFrame: Change from Baseline to 8-weeks
Secondary outcomes:
measure: Self-Reported Function
timeFrame: Change from Baseline to 4-weeks
measure: Self-Reported Function
timeFrame: Change from Baseline to 8-weeks
measure: Muscle Strength
timeFrame: Change from Baseline to 4-weeks
measure: Muscle Strength
timeFrame: Change from Baseline to 8-weeks
measure: Proprioception
timeFrame: Change from Baseline to 4-weeks
measure: Proprioception
timeFrame: Change from Baseline to 8-weeks
measure: Dynamic balance
timeFrame: Change from Baseline to 4-weeks
measure: Dynamic balance
timeFrame: Change from Baseline to 8-weeks
measure: Muscle Power
timeFrame: Change from Baseline to 4-weeks
measure: Muscle Power
timeFrame: Change from Baseline to 8-weeks
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital - Arvin Physical Therapy
state: New York
Study officials:
References: