The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is: • What is the most effective treatment method for non-insertional Achilles tendinopathy? Participants will Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.
Non-insertional Achilles Tendinopathy (AT) is a common overuse injury in adults who are both athletes and nonactive. Tendinopathy occurs when there is either a failed healing response or the failure of normal turnover or remodeling response, and results in pain and limited movement. In the military, lower-extremity injuries due to overuse, (e.g., AT) are the most common category of injuries. The most common treatment of choice for AT is exercise loading programs, however eccentric strengthening (ECC) may only improve symptoms in approximately 60% of patients. Laser-induced photobiomodulation (PBM) has been shown to increase cell proliferation and metabolism, which may aid in the repair and remodeling process. Studies have found that PBM was effective in the treatment of AT. Extracorporeal shockwave therapy (ESWT) is a process in which energy is delivered to the muscles or tendons for pain relief. Current literature supports the use of ESWT as an effective treatment for AT in combination with ECC. Overall, studies indicate that ESWT and photobiomodulation therapy (PBMT) will be effective in treating tendon injuries such as AT, however, these treatment methods have not been evaluated in comparison or combination with each other. The sub-section of AT amongst Active-Duty personnel has very limited research and given the high prevalence, should be addressed. Therefore, our study will compare three different treatment arms utilizing traditional physical therapy (PT), PT plus ESWT, PT plus PBMT, and PT plus ESWT and PBMT. Both self-reported questionnaires and measured outcomes will be used to assess the most effective treatment for AT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm\^2 that is applied in a serpentine manner over the site of injury.
Madigan Army Medical Center
Tacoma, Washington, United States
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Time frame: Baseline
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Time frame: 3-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations.
Time frame: 6-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Time frame: 12-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Time frame: 6-month
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Time frame: Baseline
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Time frame: 3-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Time frame: 6-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Time frame: 12-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Time frame: 6-month
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: Baseline
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 3-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 6-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 12-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 6-month
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Time frame: Baseline
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Time frame: 3-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Time frame: 6-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Time frame: 12-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Time frame: 6-month
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Time frame: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Time frame: 3-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Time frame: 6-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Time frame: 12-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Time frame: 6-month
Cross-sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Time frame: Baseline
Cross-sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Time frame: 12-week
Cross Sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Time frame: 6-month
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Time frame: Baseline
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Time frame: 12-week
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Time frame: 6-month
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Time frame: Baseline
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Time frame: 12-week
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Time frame: 6-month
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at baseline for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Time frame: Baseline
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 12 weeks for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Time frame: 12-week
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 6 months for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI
Time frame: 6-months
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.
Time frame: Baseline
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at 12 weeks for both limbs.
Time frame: 12-week
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.
Time frame: 6 Months
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Time frame: Baseline
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Time frame: 12-week
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Time frame: 6 Months
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: Baseline
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 12-week
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Time frame: 6 Months
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM).
Time frame: Baseline
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM)
Time frame: 12-week
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM)
Time frame: 6 Months
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