Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

NCT05751785 | Completed Results DMC FDA Device

• 1 other identifier: Photomedicine Project 10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (49)

• 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

  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

  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.

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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.

  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

  6-months

• Elastography

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

  Baseline

• Elastography

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

  12-week

• Elastography

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

  6 Months

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

  Quantitative function in heel raises to fatigue on both limbs.

  Baseline

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

  Quantitative function in heel raises to fatigue on both limbs.

  12-week

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

  Quantitative function in heel raises to fatigue on both limbs.

  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.

  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.

  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.

  6 Months

• Ankle Range of Motion (ROM)

  Quantitative function in range of motion (ROM).

  Baseline

• Ankle Range of Motion (ROM)

  Quantitative function in range of motion (ROM)

  12-week

• Ankle Range of Motion (ROM)

  Quantitative function in range of motion (ROM)

  6 Months

Study Arms (4)

Physical Therapy (PT) Only

ACTIVE COMPARATOR

Participants in the PT only arm will follow the PT program outlined above. Twice a week for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in person. In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person).

Other: Physical Therapy

PT + Photobiomodulation Therapy (PBMT)

ACTIVE COMPARATOR

The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above. A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.

Other: Physical Therapy; Device: Photobiomodulation Therapy

PT + Shockwave Therapy (SWT)

ACTIVE COMPARATOR

The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment described above. Twice a week, for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check- in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, however, this is not feasible, it may be conducted virtually; the second check-in of the week may occur virtually or in-person. In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.

Other: Physical Therapy; Device: Shockwave Therapy

PT + SWT and PBMT

ACTIVE COMPARATOR

The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described above. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF). In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).

Other: Physical Therapy; Device: Shockwave Therapy; Device: Photobiomodulation Therapy

Interventions

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.

Also known as: SOC PT

PT + Photobiomodulation Therapy (PBMT); PT + SWT and PBMT; PT + Shockwave Therapy (SWT); Physical Therapy (PT) Only

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.

Also known as: SWT

PT + SWT and PBMT; PT + Shockwave Therapy (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.

Also known as: PBMT

PT + Photobiomodulation Therapy (PBMT); PT + SWT and PBMT

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Musculoskeletal Injury Rehabilitation Research for Operational Readiness: lead
• Fort Belvoir Community Hospital: collaborator
• The Geneva Foundation: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities; Extracorporeal Shockwave Therapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Laser Therapy; Phototherapy

Results Point of Contact

• Title: Ms. Elizabeth Metzger, Senior Scientific Program Manager
• Organization: The Geneva Foundation

emetzger@genevausa.org

253-383-1398

Study Officials

• Jeremy D Schroeder

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: March 2, 2023
• Study Start: February 13, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)