Skip to content

Feasibility of using non-invasive brain stimulation to improve outcomes in patients with Achilles Tendinopathy

Feasibility of using transcranial direct current stimulation to improve outcomes in patients with Achilles Tendinopathy: A protocol for a triple blinded randomised controlled pilot trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000661370
Acronym
tDCS-AT
Enrollment
20
Registered
2026-06-03
Start date
2026-07-06
Completion date
2027-07-06
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of our pilot study is to assess the feasibility of direct non-invasive brain stimulation (transcranial direct current stimulation) use during an exercise intervention to improve pain and functional outcomes in people with Achilles tendinopathy. Specifically, we seek to examine the integrity of the study protocol, the acceptability of the intervention and to inform sample size calculations for a future large scale randomised controlled trial.

Interventions

Participants will undergo an 8-week exercise intervention consisting of 24 strength-training sessions (3 times per week) using transcranial direct current stimulation (tDCS). The exercise intervention used is informed by previous research and will be identical between the groups, to allow us to assess the feasibility, acceptability and effectiveness of the tDCS intervention independently to the exercise intervention. To complete the exercise intervention, participants will be provided a 16-week

Participants will undergo an 8-week exercise intervention consisting of 24 strength-training sessions (3 times per week) using transcranial direct current stimulation (tDCS). The exercise intervention used is informed by previous research and will be identical between the groups, to allow us to assess the feasibility, acceptability and effectiveness of the tDCS intervention independently to the exercise intervention. To complete the exercise intervention, participants will be provided a 16-week gym membership (8-weeks during the intervention and 8-week follow up period) at the provider physiotherapy clinic, but they may alternatively perform the intervention at a location of their choosing. As per the intervention outlined by Van Der Vilst & colleagues (2020) (ClinicalTrials.gov NCT02996409), the program will consist of three consecutive phases: (1) isometric-focus, (2) concentric-focus, and (3) eccentric-focus. The isometric-focus phase consists of a single leg straight knee heel raise hold and a single leg bent knee (seated) heel raise hold, participants will hold for 45 seconds for a total of 3-4 repetitions. The concentric-focus phase consists of single or double leg heel raises completed with a straight knee and a bent knee (seated) with weight specific to the participant, they will complete 3 sets of 15 repetitions. The eccentric-focus phase consists of raising up on both toes, then slowly lowering for the count of 4 on the affected side. This will be completed with the knee straight and bent, for 3 sets of 15 repetitions. Participants will perform the exercises one-on-one with the physiotherapist at the start, and at each progression point in 30-minute supervised exercise sessions during week 2, 4 and 6. Participants can progress to the next phase or increase the weight when Achilles pain is less than or equal to 3/10 on the visual analogue scale (VAS) within the 24 hours following exercise. If a participant has a flare up in symptoms (Achilles pain greater than or equal to 5/10 VAS within the 24 hours following exercise), the exercises will be regressed in intensity, or they will return to the exercises in the previous phase. Exercise videos and descriptions will be delivered to participants via physitrack (https://www.physitrack.com/en-au). Physitrack will also monitor participant adherence to the exercise program. The tDCS device (Brain Premier tDCS E1 Plus) will deliver a weak current (2 milliamps [mA]) from a 35 x 35 mm anodal electrode on the scalp at the vertex (overlaying primary motor cortex of the more symptomatic limb) to a cathodal electrode placed over the deltoid tubercle of the upper arm (on the contralateral arm to the symptomatic limb). The primary researcher (MEC) will train the participants how to self-perform tDCS on unsupervised days and will be available to help if required during these un-supervised sessions. Participants will set up and turn on the device before commencing their rehabilitation exercises. They will keep the device on for the 20-minute dose, after which they may remove the device and continue their exercises if necessary. Physitrack will monitor adherence.

Sponsors

The University of Notre Dame Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

We will recruit individuals aged over 18 years old with a clinical diagnosis of mid-portion Achilles tendinopathy, made via an experienced sports physician, over a 12-month period. Clinical diagnosis criteria will be primary location of pain at the midportion of the Achilles tendon mainly provoked under loading (e.g., running, hopping) with next day stiffness within the Achilles tendon.

Exclusion criteria

Participants will be excluded if they have: no palpation tenderness on the Achilles tendon mid-portion region, insertional Achilles tendinopathy, no radiological evidence of Achilles tendinopathy on MRI, pain duration < 3 months, previous significant lower limb injury or surgery on the included limb which resulted in a time loss from activity (e.g., anterior cruciate ligament reconstruction, Achilles tendon rupture), history of invasive intervention (e.g., open, endoscopic or ultrasound guided) on the Achilles tendon, non-invasive treatment on the Achilles tendon (e.g., physiotherapy, iontophoresis) within the last 12 months, neurological conditions (e.g., stroke, multiple sclerosis), cardiometabolic conditions (e.g., diabetes), inability to commit to rehabilitation, inability to understand English and specific tDCS contraindications

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026