Clinical trial NCT05751785: Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Official title: Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Sponsor class: FED
Collaborators: name: Fort Belvoir Community Hospital
name: The Geneva Foundation
First posted: 2023-03-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Victorian Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: Baseline
measure: Victorian Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: 3-week
measure: Victorian Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: 6-week
measure: Victorian Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: 12-week
measure: Victorian Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: 6-month
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Baseline
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 3-week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 6-week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 12-week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 6-month
measure: Defense and Veteran's Pain Rating Scale (DVPRS)
timeFrame: Baseline
measure: Defense and Veteran's Pain Rating Scale (DVPRS)
timeFrame: 3-week
measure: Defense and Veteran's Pain Rating Scale (DVPRS)
timeFrame: 6-week
measure: Defense and Veteran's Pain Rating Scale (DVPRS)
timeFrame: 12-week
measure: Defense and Veteran's Pain Rating Scale (DVPRS)
timeFrame: 6-month
measure: University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: Baseline
measure: University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: 3-week
measure: University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: 6-week
measure: University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: 12-week
measure: University of Wisconsin Running Injury and Recovery Index (UWRI)
timeFrame: 6-month
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 3-week
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 6-week
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 12-week
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 6-month
measure: Cross-sectional area
timeFrame: Baseline
measure: Cross-sectional area
timeFrame: 12-week
measure: Cross Sectional area
timeFrame: 6-month
measure: Width
timeFrame: Baseline
measure: Width
timeFrame: 12-week
measure: Width
timeFrame: 6-month
measure: Degree of thickening
timeFrame: Baseline
measure: Degree of thickening
timeFrame: 12-week
measure: Degree of thickening
timeFrame: 6-month
measure: Relative neovascularity
timeFrame: Baseline
measure: Relative neovascularity
timeFrame: 12-week
measure: Relative neovascularity
timeFrame: 6-months
measure: Elastography
timeFrame: Baseline
measure: Elastography
timeFrame: 12-week
measure: Elastography
timeFrame: 6 Months
measure: Heel raises-Quantitative function in heel raises to fatigue.
timeFrame: Baseline
measure: Heel raises-Quantitative function in heel raises to fatigue.
timeFrame: 12-week
measure: Heel raises-Quantitative function in heel raises to fatigue.
timeFrame: 6 Months
measure: Hops
timeFrame: Baseline
measure: Hops
timeFrame: 12-week
measure: Hops
timeFrame: 6 Months
measure: Ankle range of motion
timeFrame: Baseline
measure: Ankle range of motion
timeFrame: 12-week
measure: Ankle range of motion
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Jeremy D Schroeder
role: PRINCIPAL_INVESTIGATOR
References: