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Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Therapy

Shockwave Therapy

Photobiomodulation Therapy

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Madigan Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Physical Therapy (PT) Only

PT + Photobiomodulation Therapy (PBMT)

PT + Shockwave Therapy (SWT)

PT + SWT and PBMT

Arm Description

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).

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.

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.

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).

Outcomes

Primary Outcome Measures

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

Symptoms severity specific to Achilles will be Victorian Institute of Sports Assessment - Achilles (VISA-A). The VISA-A is currently the only valid and reliable measure to assess function and pain in AT (validity, P<0.01; test-re-test reliability, r = 0.98). Rating scale between 0-10.

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

Lower Extremity Functional Scale (LEFS)

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Lower Extremity Functional Scale (LEFS)

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Lower Extremity Functional Scale (LEFS)

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Lower Extremity Functional Scale (LEFS)

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Lower Extremity Functional Scale (LEFS)

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Defense and Veteran's Pain Rating Scale (DVPRS)

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Defense and Veteran's Pain Rating Scale (DVPRS)

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Defense and Veteran's Pain Rating Scale (DVPRS)

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Defense and Veteran's Pain Rating Scale (DVPRS)

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Defense and Veteran's Pain Rating Scale (DVPRS)

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

University of Wisconsin Running Injury and Recovery Index (UWRI)

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running.

University of Wisconsin Running Injury and Recovery Index (UWRI)

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

University of Wisconsin Running Injury and Recovery Index (UWRI)

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

University of Wisconsin Running Injury and Recovery Index (UWRI)

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

University of Wisconsin Running Injury and Recovery Index (UWRI)

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

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

Patient-Reported Outcomes Measurement Information System (PROMIS-29) will be used to capture other aspects of non-disease specific measures of health-related domains (physical, mental and social health). Rating scale from 1-5.

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

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).

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).

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).

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).

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).

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).

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).

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).

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).

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 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI

Relative neovascularity

Elastography

Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs. The elastography evaluation should be conducted in two orthogonal planes at the area of maximal thickness/width, IAW manufacture guidance on elastography image collections.

Elastography

Heel raises-Quantitative function in heel raises to fatigue.

Quantitative function in heel raises to fatigue on both limbs.

Heel raises-Quantitative function in heel raises to fatigue.

Quantitative function in heel raises to fatigue on both limbs.

Heel raises-Quantitative function in heel raises to fatigue.

Quantitative function in heel raises to fatigue on both limbs.

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).

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).

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).

Ankle range of motion

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Ankle range of motion

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Ankle range of motion

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Secondary Outcome Measures

Full Information

NCT ID

NCT05751785

First Posted

January 27, 2023

Last Updated

February 27, 2023

Sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Collaborators

Fort Belvoir Community Hospital, The Geneva Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05751785

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Collaborators

Fort Belvoir Community Hospital, The Geneva Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Therapy (PT) Only

Arm Type

Active Comparator

Arm Description

Arm Title

PT + Photobiomodulation Therapy (PBMT)

Arm Type

Active Comparator

Arm Description

Arm Title

PT + Shockwave Therapy (SWT)

Arm Type

Active Comparator

Arm Description

Arm Title

PT + SWT and PBMT

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Physical Therapy

Other Intervention Name(s)

SOC PT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Shockwave Therapy

Other Intervention Name(s)

SWT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Photobiomodulation Therapy

Other Intervention Name(s)

PBMT

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline

Title

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

Description

Time Frame

3-week

Title

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

Description

Time Frame

6-week

Title

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

Description

Time Frame

12-week

Title

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

Description

Time Frame

6-month

Title

Lower Extremity Functional Scale (LEFS)

Description

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Time Frame

Baseline

Title

Lower Extremity Functional Scale (LEFS)

Description

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Time Frame

3-week

Title

Lower Extremity Functional Scale (LEFS)

Description

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Time Frame

6-week

Title

Lower Extremity Functional Scale (LEFS)

Description

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Time Frame

12-week

Title

Lower Extremity Functional Scale (LEFS)

Description

Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.

Time Frame

6-month

Title

Defense and Veteran's Pain Rating Scale (DVPRS)

Description

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Time Frame

Baseline

Title

Defense and Veteran's Pain Rating Scale (DVPRS)

Description

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Time Frame

3-week

Title

Defense and Veteran's Pain Rating Scale (DVPRS)

Description

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Time Frame

6-week

Title

Defense and Veteran's Pain Rating Scale (DVPRS)

Description

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Time Frame

12-week

Title

Defense and Veteran's Pain Rating Scale (DVPRS)

Description

Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.

Time Frame

6-month

Title

University of Wisconsin Running Injury and Recovery Index (UWRI)

Description

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running.

Time Frame

Baseline

Title

University of Wisconsin Running Injury and Recovery Index (UWRI)

Description

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

Time Frame

3-week

Title

University of Wisconsin Running Injury and Recovery Index (UWRI)

Description

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

Time Frame

6-week

Title

University of Wisconsin Running Injury and Recovery Index (UWRI)

Description

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

Time Frame

12-week

Title

University of Wisconsin Running Injury and Recovery Index (UWRI)

Description

The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.

Time Frame

6-month

Title

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

Description

Time Frame

Baseline

Title

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

Description

Time Frame

3-week

Title

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

Description

Time Frame

6-week

Title

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

Description

Time Frame

12-week

Title

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

Description

Time Frame

6-month

Title

Cross-sectional area

Description

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

Time Frame

Baseline

Title

Cross-sectional area

Description

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

Time Frame

12-week

Title

Cross Sectional area

Description

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

Time Frame

6-month

Title

Width

Description

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

Time Frame

Baseline

Title

Width

Description

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

Time Frame

12-week

Title

Width

Description

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

Time Frame

6-month

Title

Degree of thickening

Description

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).

Time Frame

Baseline

Title

Degree of thickening

Description

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).

Time Frame

12-week

Title

Degree of thickening

Description

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).

Time Frame

6-month

Title

Relative neovascularity

Description

Time Frame

Baseline

Title

Relative neovascularity

Description

Time Frame

12-week

Title

Relative neovascularity

Description

Time Frame

6-months

Title

Elastography

Description

Time Frame

Baseline

Title

Elastography

Description

Time Frame

12-week

Title

Elastography

Description

Time Frame

6 Months

Title

Heel raises-Quantitative function in heel raises to fatigue.

Description

Quantitative function in heel raises to fatigue on both limbs.

Time Frame

Baseline

Title

Heel raises-Quantitative function in heel raises to fatigue.

Description

Quantitative function in heel raises to fatigue on both limbs.

Time Frame

12-week

Title

Heel raises-Quantitative function in heel raises to fatigue.

Description

Quantitative function in heel raises to fatigue on both limbs.

Time Frame

6 Months

Title

Hops

Description

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).

Time Frame

Baseline

Title

Hops

Description

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).

Time Frame

12-week

Title

Hops

Description

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).

Time Frame

6 Months

Title

Ankle range of motion

Description

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Time Frame

Baseline

Title

Ankle range of motion

Description

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Time Frame

12-week

Title

Ankle range of motion

Description

Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be measured using a goniometer.

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeremy D Schroeder

Phone

253-968-2077

jeremy.d.schroeder.mil@health.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Rossi

Phone

551-404-1923

rrossi@genevausa.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeremy D Schroeder

Organizational Affiliation

Madigan Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Rossi

Phone

551-404-1923

rrossi@genevausa.org

First Name & Middle Initial & Last Name & Degree

Samantha McKee

Phone

229-412-4567

smckee@genevausa.org

First Name & Middle Initial & Last Name & Degree

Joseph W Galvin

First Name & Middle Initial & Last Name & Degree

Scott P Grogan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

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