Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

Not Applicable

Completed

Conditions: Achilles Tendinopathy

Registration Number: NCT05751785

Lead Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

DEERS Eligible
Between the ages of 18-64
Currently Active Duty in any of the US Armed Forces
Clinical diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral) by a healthcare provider based on accepted diagnostic criteria.
Able to read and understand English language for consent purposes
Able to commit to 3-weeks of intervention and 6-months of follow-up

Exclusion Criteria

Primary insertional Achilles tendinopathy
Platelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 months
Received dry needling within the past 4 weeks
Previously completed the Silbernagel protocol for Achilles tendinopathy within the past 3 months
Received SWT within the past 3 months to their Achilles
Tattoo in the area of treatment (due to sensitivity to PBMT)
Current use of pacemaker
Patients with a known underlying cardiac disease that could be affected by SWT
Patients with neuropathy affecting sensation to pain
Current use of medications associated with sensitivity to heat or light (e.g. amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling.
Achilles tendon tear or prior Achilles tendon surgery
Recent lower extremity injury within the last 3 months that required professional medical attention (e.g., ankle sprain, meniscus)
Concurrent participation in another research study addressing pain issue
Previously enrolled in the study for contralateral (opposite) leg
Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy) as determined by hCG urine test
Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside of Achilles tendinopathy, or other contraindications to PBMT or SWT

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sports Assessment - Achilles (VISA-A)	6-month	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
Width	6-month	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).
Defense and Veteran's Pain Rating Scale (DVPRS)	6-month	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.
Elastography	6 Months	Measures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.
Hops	6 Months	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.
Lower Extremity Functional Scale (LEFS)	6-month	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.
University of Wisconsin Running Injury and Recovery Index (UWRI)	6-month	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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	6-month	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.
Cross-sectional Area	12-week	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).
Cross Sectional Area	6-month	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).
Ankle Range of Motion (ROM)	6 Months	Quantitative function in range of motion (ROM)
Degree of Thickening	6-month	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).
Relative Neovascularity	6-months	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
Heel Raises-Quantitative Function in Heel Raises to Fatigue.	6 Months	Quantitative function in heel raises to fatigue on both limbs.