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Recruiting
NCT05751785
Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Conditions: Achilles Tendinopathy
Sex: All
Ages: 18 Years – 64 Years
Phase: NA
Enrollment: 160
Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Location: United States
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 willResearchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.
Eligibility Criteria
Inclusion Criteria:DEERS EligibleBetween the ages of 18-64Currently Active Duty in any of the US Armed ForcesClinical 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 purposesAble to commit to 3-weeks of intervention and 6-months of follow-upExclusion Criteria:Primary insertional Achilles tendinopathyPlatelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 monthsReceived dry needling within the past 4 weeksPreviously completed the Silbernagel protocol for Achilles tendinopathy within the past 3 monthsReceived SWT within the past 3 months to their AchillesTattoo in the area of treatment (due to sensitivity to PBMT)Current use of pacemakerPatients with a known underlying cardiac disease that could be affected by SWTPatients with neuropathy affecting sensation to painCurrent 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 surgeryRecent 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 issuePreviously enrolled in the study for contralateral (opposite) legCurrently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy) as determined by hCG urine testDiagnosis 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
Source: ClinicalTrials.gov (NCT05751785). StuddyBuddy aggregates publicly available trial information.