Effect of Additional Treatment With NMES After Achilles Tendon Rupture
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06009978 |
|
Recruitment Status :
Recruiting
First Posted : August 24, 2023
Last Update Posted : April 24, 2024
|
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 10, 2023 | ||||||||
| First Posted Date ICMJE | August 24, 2023 | ||||||||
| Last Update Posted Date | April 24, 2024 | ||||||||
| Actual Study Start Date ICMJE | November 1, 2023 | ||||||||
| Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Additional Treatment With NMES After Achilles Tendon Rupture | ||||||||
| Official Title ICMJE | The Effect of Early Treatment With Neuromuscular, Electrical Stimulation (NMES) After Achilles Tendon Rupture | ||||||||
| Brief Summary | Increased knowledge is needed about new methods how to treat patients with Achilles tendon ruptures (ATR). A goal is to be able to individualize as well as improve treatment beyond the question about if surgery should be used or not. An overall aim of the project is to, in a randomized controlled trial (RCT), explore what impact a new treatment method with Neuromuscular Electrical Stimulation (NMES) - attached on the patients ́ calf muscles on the injured leg - in the early stages after an ATR, may have on tendon length, functional performance, biomechanical variables and patient reported outcome, both in the short and long term after the injury. 70 patients are planned to be included in this RCT and will be evaluated 3,6 and 12 months after their injury. Primary outcome will be heel-rise height. Secondary outcome will be tendon length, jumping ability, patient- reported outcome and biomechanical loading pattern. There is also a need to explore if the patients ́ loading patterns improve after treatment with NMES. Therefore, biomechanical variables in lower leg during walking and jumping will also be evaluated one year after their injury. The planned studies include completely new ways of exploring how to optimize the rehabilitation after an ATR. Since there might be an increased risk for overuse injuries in the healthy limb, there will also be focus on how the non- injured limb may be affected of an ATR. Taken together, this new knowledge can be helpful in the clinical setting to individualize and optimize patients' treatment and rehabilitation with the goal to guide the patient return to the same, or higher level of, physical activity as before the injury. |
||||||||
| Detailed Description | BACKGROUND: There is limited knowledge about how calf muscle performance and tendon elongation affect the patient's discomfort or ability to return to previous activity levels after an Achilles Tendon rupture. Tendon elongation can cause a changed recruitment pattern of the different parts of the muscle complex triceps surae. There is some evidence that treatment with Neuromuscular Electrical Stimulation (NMES) can improve postural balance by stimulating the calf muscles in elderly people with impaired balance. A newly published study concluded that NMES treatment the first 12 weeks after an ATR, did not have any impact on calf circumference or patient-reported outcome the first 12 weeks after the injury. Studies have shown that only 20-40% of patients are able to return to the same level of physical activity as before the injury. Although patients return to full participation in sports, their level of performance is often adversely affected. Obviously, there can be different reasons for this. In a newly published study, it was concluded that joint power distribution during a drop countermovement jump was affected by fear of reinjury as long as 2 years after an ATR. However, there is still a lot to explore about if an improved physical function in the injured calf muscle may decrease the fear of re-injury and therefore positively affect the ability to return to previous physical activity level after an ATR. Therefore, new treatments with the goal to increase the possibility to return to the same physical level as before the injury are very much needed. An ATR can lead to reduced strength development in the ankle with simultaneous increased load development in the knee joint in the injured leg for as long as 6 years after the injury. Reduction in strength and endurance in the calf muscle has been shown to persist long after the injury. Exhaustion of the lower leg muscles affects the valgus moment in the knee as well as kinematic variables in athletes during vertical jumps, which may affect the risk of knee injury. However, there is a lack of knowledge about how lower leg function, biomechanics and muscle recruitment are affected in patients after an ATR. It is also unknown how this injury affects the healthy limb and perhaps increase the risk of overload injuries in other parts of the body. HYPOTHESIS: Additional treatment with NMES in early stages after an Achilles Tendon rupture have a positive impact on lower leg function both in the short and long term. PURPOSE AND SPECIFIC GOALS: An overall aim of the project is to, in a randomized controlled trial, explore what impact a new treatment method with NMES in the early stages after an ATR may have on calf muscle performance, tendon length, jumping ability, biomechanical variables and patient reported outcome both in the short and long term after the injury. There will also be focus on how the non-injured limb may be affected of an Achilles tendon rupture. This new knowledge can be helpful in the clinical setting to
OBJECTIVES:
METHOD The design of this study is a randomized controlled trial. A power calculation (p <0.05, power 80%) showed that 28 patients who receive and 28 who do not receive treatment with NMES are needed to be able to show a clinically important difference of 10% in heel-rise height. A total of 70 patients with ATR will be included and randomized to receive or to not receive additional therapy with NMES during the first 3-8 weeks after their ATR. Four electrodes connected with the NMES equipment will be attached on the patients ́ calf on the injured leg and they will use the equipment in their home two times a day á 15 minutes for six weeks, that is 3-8 weeks after the injury. Primary outcome will be the heel-rise height during the heel-rise work test. Standardized seated heel-rise as well as single-leg standing heel- rise will be evaluated 3, 6 and 12 months after the injury in both the injured and the healthy limb. The heel-rise work test will be evaluated with a linear encoder connected to the software MuscleLab®. Tendon length will be evaluated with ultrasound 8 weeks and 3, 6 and 12 months after the injury. The measurement is found to be reliable and valid. The tendon length will be evaluated with ultrasonography with extended field of view using a wideband array linear probe (5.0- 13.0 MHz). The B- mode at 10 MHz and a depth of 3 cm will be used to record the images. One year after the injury, kinematic and kinetic variables together with EMG will be evaluated during walking, running and jumping. For collection of the biomechanical data, 16 7+ cameras and 4 force plates will be used. This new equipment is available in a new motional analysis lab at our research unit. Fifty-five reflectors will be attached on the patients´ body to be able to detect segmental movements. EMG electrodes on the medial and lateral Gastrocnemius, Soleus and Tibialis anterior muscles will also be attached on the patient in order to measure how the muscles are recruited in the different activities. Both healthy and injured sides will be analyzed. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Device: Neuromuscular electrical stimulation (NMES)
Neuromuscular electrical stimulation (NMES) 2 times a day á 15 minutes from the third to the eight week after injury. The additional treatment will be perform in the patients home by themselves
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
70 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2026 | ||||||||
| Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Sweden | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT06009978 | ||||||||
| Other Study ID Numbers ICMJE | 2022-00921-02 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Current Responsible Party | Vastra Gotaland Region | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | Vastra Gotaland Region | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Göteborg University | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Vastra Gotaland Region | ||||||||
| Verification Date | May 2023 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||