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Completed

NCT Number: NCT05751785

Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

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.

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Key information

Conditions

Achilles Tendinopathy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

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.

Other names: SOC PT

Shockwave therapy

Device

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.

Other names: SWT

photobiomodulation therapy

Device

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.

Other names: PBMT

Primary outcomes

  1. Victorian Institute of Sports Assessment - Achilles (VISA-A)

    Time frame: Baseline

    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

  2. Victorian Institute of Sports Assessment - Achilles (VISA-A)

    Time frame: 3-week

    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

  3. Victorian Institute of Sports Assessment - Achilles (VISA-A)

    Time frame: 6-week

    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.

  4. Victorian Institute of Sports Assessment - Achilles (VISA-A)

    Time frame: 12-week

    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

  5. Victorian Institute of Sports Assessment - Achilles (VISA-A)

    Time frame: 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

  6. Lower Extremity Functional Scale (LEFS)

    Time frame: Baseline

    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.

  7. Lower Extremity Functional Scale (LEFS)

    Time frame: 3-week

    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.

  8. Lower Extremity Functional Scale (LEFS)

    Time frame: 6-week

    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.

  9. Lower Extremity Functional Scale (LEFS)

    Time frame: 12-week

    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.

  10. Lower Extremity Functional Scale (LEFS)

    Time frame: 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.

  11. Defense and Veteran's Pain Rating Scale (DVPRS)

    Time frame: Baseline

    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.

  12. Defense and Veteran's Pain Rating Scale (DVPRS)

    Time frame: 3-week

    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.

  13. Defense and Veteran's Pain Rating Scale (DVPRS)

    Time frame: 6-week

    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.

  14. Defense and Veteran's Pain Rating Scale (DVPRS)

    Time frame: 12-week

    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.

  15. Defense and Veteran's Pain Rating Scale (DVPRS)

    Time frame: 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.

  16. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: Baseline

    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.

  17. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: 3-week

    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.

  18. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: 6-week

    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.

  19. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: 12-week

    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.

  20. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: 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.

  21. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: Baseline

    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.

  22. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 3-week

    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.

  23. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 6-week

    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.

  24. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 12-week

    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.

  25. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 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.

  26. Cross-sectional Area

    Time frame: Baseline

    Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).

  27. Cross-sectional Area

    Time frame: 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).

  28. Cross Sectional Area

    Time frame: 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).

  29. Width

    Time frame: Baseline

    Measures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).

  30. Width

    Time frame: 12-week

    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).

  31. Width

    Time frame: 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).

  32. Degree of Thickening

    Time frame: Baseline

    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).

  33. Degree of Thickening

    Time frame: 12-week

    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).

  34. Degree of Thickening

    Time frame: 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).

  35. Relative Neovascularity

    Time frame: Baseline

    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.

  36. Relative Neovascularity

    Time frame: 12-week

    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.

  37. Relative Neovascularity

    Time frame: 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

  38. Elastography

    Time frame: Baseline

    Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.

  39. Elastography

    Time frame: 12-week

    Measures of interest include elastography. A study team member will assess ultrasound measures at 12 weeks for both limbs.

  40. Elastography

    Time frame: 6 Months

    Measures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.

  41. Heel Raises-Quantitative Function in Heel Raises to Fatigue.

    Time frame: Baseline

    Quantitative function in heel raises to fatigue on both limbs.

  42. Heel Raises-Quantitative Function in Heel Raises to Fatigue.

    Time frame: 12-week

    Quantitative function in heel raises to fatigue on both limbs.

  43. Heel Raises-Quantitative Function in Heel Raises to Fatigue.

    Time frame: 6 Months

    Quantitative function in heel raises to fatigue on both limbs.

  44. Hops

    Time frame: Baseline

    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.

  45. Hops

    Time frame: 12-week

    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.

  46. Hops

    Time frame: 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.

  47. Ankle Range of Motion (ROM)

    Time frame: Baseline

    Quantitative function in range of motion (ROM).

  48. Ankle Range of Motion (ROM)

    Time frame: 12-week

    Quantitative function in range of motion (ROM)

  49. Ankle Range of Motion (ROM)

    Time frame: 6 Months

    Quantitative function in range of motion (ROM)

Sponsors and collaborators

Lead sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Fed

Collaborators

  • Fort Belvoir Community Hospital
  • The Geneva Foundation

Registry information

Official study title

Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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