Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Not Applicable

Terminated

• Conditions: Ankle Sprains; Musculoskeletal Injury

• Registration Number: NCT04902274
• Lead Sponsor: Keller Army Community Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-19
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Pain Rating	Change from Baseline to 8-weeks	Numerical Pain Rating Scale assessment of Current, Best 24-hour, Worst 24-hour Pain

Secondary Outcome Measures

Name	Time	Method
Self-Reported Function	Change from Baseline to 8-weeks	Patient report of function assessed by Single Assessment Numeric Evaluation
Muscle Power	Change from Baseline to 8-weeks	Single leg hop test for distance
Dynamic balance	Change from Baseline to 8-weeks	Dynamic balance assessed by the Y-balance Test
Proprioception	Change from Baseline to 8-weeks	Limits of stability test and unilateral stance test assessed by NeuroCom EquiTest
Muscle Strength	Change from Baseline to 8-weeks	Isometric dorsiflexion, plantarflexion, inversion, eversion assessed by hand-held dynamometry

Trial Locations

Locations (1)

Keller Army Community Hospital - Arvin Physical Therapy; 🇺🇸 West Point, New York, United States