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NMES for Achilles Tendon Rupture

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ClinicalTrials.gov Identifier: NCT04727047
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Daniel Cortes, Penn State University

Brief Summary:
The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Device: neuromuscular electrical stimulation Not Applicable

Detailed Description:

Achilles Tendon Ruptures (ATR) are common and permanently affect the function of the lower leg. Regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. It is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. The initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. However, long-term atrophy may be related to tendon elongation. On the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. However, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. Therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy.

The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. Therefore, NMES can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. This approach can potentially overcome limitations of the current rehabilitation protocols.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Active Comparator: Neuromuscular Electrical Stimulation

Neuromuscular electrical stimulation will be applied to the calf muscles. The level of stimulation will be increased weekly from 10 to 30 mA during the first 6 weeks after surgery.

In addition, patients will follow standard therapy for Achilles tendon repair.

Device: neuromuscular electrical stimulation
All subjects will receive standard rehabilitation for Achilles tendon repair. In addition, neuromuscular electrical stimulation will be applied to the calf muscles of the injured leg. The stimulation volume, the electrode placement and the intensity of the stimulation will be selected based on the mechanical strength of healing Achilles tendon. The intervention will be applied for 6 weeks after repair.

No Intervention: Control
Patients will follow standard therapy for Achilles tendon repair.



Primary Outcome Measures :
  1. Ability to perform a single heel rise [ Time Frame: Week 12 ]
    The ability of patients to perform a single heel rise using the injured will be tested.


Secondary Outcome Measures :
  1. Tendon length [ Time Frame: Week 6 and12 ]
    Length from the tendon insertion to the myotendinous junction

  2. Tendon cross-sectional area [ Time Frame: Week 6, 12 ]
    Area of the tendon measured via ultrasound imaging at the rupture location

  3. Gastrocnemius muscle cross-sectional area [ Time Frame: Week 1, 6, 12 ]
    Area of the tendon measured via ultrasound imaging at the rupture location

  4. Soleus muscle cross-sectional area [ Time Frame: Week 1, 6, 12 ]
    Area of the tendon measured via ultrasound imaging at the rupture location

  5. Foot and Ankle Outcome Score (FAOS) [ Time Frame: Week 6, 12 ]
    Score that assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and foot/ankle related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.

  6. Achilles Total Rupture Score [ Time Frame: Week 6, 12 ]
    It consists of ten items evaluating aspects of symptoms and function. Each item has scores ranging between 0 and 10 on a Likert scale. The instrument therefore has a maximum score of 100, which corresponds to no symptoms and full function.

  7. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Week 6, 12 ]
    Questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achilles tendon rupture

Exclusion Criteria:

  1. Those unable to understand spoken English.
  2. Participants treated non-operatively
  3. Augmented surgical repair (i.e., use of additional tissue at the repair site)
  4. Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
  5. Allergy to ultrasound gel
  6. Any other condition affecting the ability of the participant to walk or jump
  7. Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
  8. Those unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727047


Contacts
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Contact: Daniel Cortes 814-863-3103 dhc13@psu.edu
Contact: Andrea Horne (717) 531-7127 ahorne@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Contact: Daniel Cortes, PhD    814-863-3103    dhc13@psu.edu   
Contact: Andrea Horne    (717) 531-7127    ahorne@pennstatehealth.psu.edu   
Sponsors and Collaborators
Penn State University
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Responsible Party: Daniel Cortes, Assistant Professor, Penn State University
ClinicalTrials.gov Identifier: NCT04727047    
Other Study ID Numbers: STUDY00016121
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries