NMES for Achilles Tendon Rupture
Primary Purpose
Achilles Tendon Rupture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture
Eligibility Criteria
Inclusion Criteria:
- Achilles tendon rupture
Exclusion Criteria:
- Those unable to understand spoken English.
- Participants treated non-operatively
- Augmented surgical repair (i.e., use of additional tissue at the repair site)
- Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
- Allergy to ultrasound gel
- Any other condition affecting the ability of the participant to walk or jump
- Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
- Those unable to consent
Sites / Locations
- Penn State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Neuromuscular Electrical Stimulation
Control
Arm Description
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.
Patients will follow standard therapy for Achilles tendon repair.
Outcomes
Primary Outcome Measures
Ability to perform a single heel rise
The ability of patients to perform a single heel rise using the injured will be tested.
Secondary Outcome Measures
Tendon length
Length from the tendon insertion to the myotendinous junction
Tendon cross-sectional area
Area of the tendon measured via ultrasound imaging at the rupture location
Gastrocnemius muscle cross-sectional area
Area of the tendon measured via ultrasound imaging at the rupture location
Soleus muscle cross-sectional area
Area of the tendon measured via ultrasound imaging at the rupture location
Foot and Ankle Outcome Score (FAOS)
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.
Achilles Total Rupture Score
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.
Tampa Scale for Kinesiophobia (TSK)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04727047
Brief Title
NMES for Achilles Tendon Rupture
Official Title
Neuromuscular Electrical Stimulation for Achilles Tendon Rupture Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular Electrical Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will follow standard therapy for Achilles tendon repair.
Intervention Type
Device
Intervention Name(s)
neuromuscular electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to perform a single heel rise
Description
The ability of patients to perform a single heel rise using the injured will be tested.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Tendon length
Description
Length from the tendon insertion to the myotendinous junction
Time Frame
Week 6 and12
Title
Tendon cross-sectional area
Description
Area of the tendon measured via ultrasound imaging at the rupture location
Time Frame
Week 6, 12
Title
Gastrocnemius muscle cross-sectional area
Description
Area of the tendon measured via ultrasound imaging at the rupture location
Time Frame
Week 1, 6, 12
Title
Soleus muscle cross-sectional area
Description
Area of the tendon measured via ultrasound imaging at the rupture location
Time Frame
Week 1, 6, 12
Title
Foot and Ankle Outcome Score (FAOS)
Description
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.
Time Frame
Week 6, 12
Title
Achilles Total Rupture Score
Description
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.
Time Frame
Week 6, 12
Title
Tampa Scale for Kinesiophobia (TSK)
Description
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.
Time Frame
Week 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Achilles tendon rupture
Exclusion Criteria:
Those unable to understand spoken English.
Participants treated non-operatively
Augmented surgical repair (i.e., use of additional tissue at the repair site)
Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
Allergy to ultrasound gel
Any other condition affecting the ability of the participant to walk or jump
Any other health conditions known to impair normal healing: Diabetes, Cardiovascular conditions decreasing blood supply to the leg
Those unable to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Cortes
Phone
814-863-3103
Email
dhc13@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Myers
Phone
717-517-2576
Email
amyers1@pennstatehealth.psu.edu
Facility Information:
Facility Name
Penn State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Cortes, PhD
Phone
814-863-3103
Email
dhc13@psu.edu
First Name & Middle Initial & Last Name & Degree
Shabnam Rahimnezhad, PhD
Phone
586-321-2675
Email
spr5679@psu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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NMES for Achilles Tendon Rupture
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