Using electrical stimulation to improve recovery after Achilles tendon rupture
The Effect of Early Treatment With Neuromuscular, Electrical Stimulation (NMES) After Achilles Tendon Rupture
This study tests if using electrical stimulation on the calf muscles can help people recover better after an Achilles tendon rupture compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Mölndal, VGregion) |
| Trial ID | NCT06009978 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Neuromuscular Electrical Stimulation (NMES) on patients who have suffered an Achilles tendon rupture. The study aims to determine how NMES applied to the calf muscles in the early stages post-injury can influence tendon length, functional performance, and patient-reported outcomes over time. A total of 70 participants will be randomly assigned to receive either NMES or standard care, with evaluations conducted at 3, 6, and 12 months after the injury. The primary focus is on measuring heel-rise height, while secondary outcomes include tendon length, jumping ability, and biomechanical loading patterns.
Who should consider this trial
Good fit: Ideal candidates are individuals who have sustained an Achilles tendon rupture and received treatment within two days of the injury.
Not a fit: Patients with prior Achilles tendon ruptures, significant comorbidities, or those unable to understand instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery and improve the quality of life for patients recovering from Achilles tendon ruptures.
How similar studies have performed: While some studies have explored NMES in similar contexts, this specific approach to treating Achilles tendon ruptures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Achilles Tendon rupture * The injury should have been treated within two days from the trauma * The rupture is located in the mid portion of the tendon Exclusion Criteria: * Pregnancy * Having a pace maker, intra cardiac defibrillator or other active implant * Having had an Achilles Tendon rupture before, regardless of side * Having an earlier injury that will have an impact on lower leg function, regardless of side * Diabetes * Neuro vascular disease * Immunosuppressive treatment * Difficulties to understand the language or difficulties in understand instructions. * Unable to consent
Where this trial is running
Mölndal, VGregion
- Forskningsenhet Ortopedi, Sahlgrenska universitetssjukhuset, Mölndal — Mölndal, VGregion, Sweden (Recruiting)
Study contacts
- Principal investigator: Katarina Nilsson Helander, Ass.Prof — VGregion
- Study coordinator: Katarina Nilsson Helander, Ass.prof.
- Email: katarina.nilsson.helander@vgregion.se
- Phone: +46 70-3218420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.