Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05751785

Enrollment

Registered

2023-03-02

Start date

2023-02-13

Completion date

2024-11-14

Last updated

2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendinopathy

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.

Interventions

OTHERPhysical Therapy

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.

DEVICEShockwave Therapy

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.

DEVICEPhotobiomodulation Therapy

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Victorian Institute of Sports Assessment - Achilles (VISA-A)	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
Lower Extremity Functional Scale (LEFS)	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.
Defense and Veteran's Pain Rating Scale (DVPRS)	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.
University of Wisconsin Running Injury and Recovery Index (UWRI)	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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.
Cross-sectional Area	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).
Cross Sectional Area	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).
Width	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).
Degree of Thickening	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).
Relative Neovascularity	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.
Elastography	Baseline	Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.
Heel Raises-Quantitative Function in Heel Raises to Fatigue.	Baseline	Quantitative function in heel raises to fatigue on both limbs.
Hops	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.
Ankle Range of Motion (ROM)	Baseline	Quantitative function in range of motion (ROM).

Countries

United States

Participant flow

Recruitment details

A total of 48 participants consented to be in the study. However, 2 participants were withdrawn prior to randomization due to failing formal screening criteria. This left 46 participants to be randomized into a study arm assignment.

Pre-assignment details

Formal Screening (prior to study arm randomization): Post-consent, secondary exclusion of pregnancy will be determined by an hCG urine pregnancy test for females of child-bearing age and capacity. Additionally, all participants will be screened for insertional AT as the primary clinical diagnosis with a 3 part test. If the insertional AT component is identified as the primary source of Achilles pain, we formally withdrew the participants from the study prior to randomization.

Participants by arm

Arm	Count
Physical Therapy (PT) Only 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). 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.	11
PT + Photobiomodulation Therapy (PBMT) 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. Physical Therapy: 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. Photobiomodulation Therapy: 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.	11
PT + Shockwave Therapy (SWT) The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment. 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. Shockwave Therapy: 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.	12
PT + SWT and PBMT The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described. 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).	12
Total	46

Baseline characteristics

Characteristic	Physical Therapy (PT) Only	PT + Photobiomodulation Therapy (PBMT)	PT + Shockwave Therapy (SWT)	PT + SWT and PBMT	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	11 Participants	11 Participants	12 Participants	12 Participants	46 Participants
Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race/Ethnicity Asian or Pacific Islander	2 Participants	0 Participants	0 Participants	2 Participants	4 Participants
Race/Ethnicity, Customized Race/Ethnicity Black or African American (not Hispanic)	3 Participants	3 Participants	3 Participants	2 Participants	11 Participants
Race/Ethnicity, Customized Race/Ethnicity Hispanic	0 Participants	0 Participants	4 Participants	3 Participants	7 Participants
Race/Ethnicity, Customized Race/Ethnicity Other	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race/Ethnicity White (not Hispanic	6 Participants	7 Participants	5 Participants	5 Participants	23 Participants
Region of Enrollment United States	11 participants	11 participants	12 participants	12 participants	46 participants
Sex: Female, Male Female	2 Participants	2 Participants	4 Participants	3 Participants	11 Participants
Sex: Female, Male Male	9 Participants	9 Participants	8 Participants	9 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 10	0 / 12	0 / 12
other Total, other adverse events	8 / 11	8 / 10	9 / 12	7 / 12
serious Total, serious adverse events	4 / 11	2 / 10	2 / 12	0 / 12

Outcome results

Primary

Ankle Range of Motion (ROM)

Quantitative function in range of motion (ROM)

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Ankle Range of Motion (ROM)	14.89 degrees	Standard Deviation 3.14
PT + Photobiomodulation Therapy (PBMT)	Ankle Range of Motion (ROM)	13.80 degrees	Standard Deviation 6.29
PT + Shockwave Therapy (SWT)	Ankle Range of Motion (ROM)	10.60 degrees	Standard Deviation 3.58
PT + SWT and PBMT	Ankle Range of Motion (ROM)	10.80 degrees	Standard Deviation 3.37

Primary

Ankle Range of Motion (ROM)

Quantitative function in range of motion (ROM).

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Ankle Range of Motion (ROM)	12.18 degrees	Standard Deviation 4.39
PT + Photobiomodulation Therapy (PBMT)	Ankle Range of Motion (ROM)	12.40 degrees	Standard Deviation 4.18
PT + Shockwave Therapy (SWT)	Ankle Range of Motion (ROM)	12.67 degrees	Standard Deviation 9.74
PT + SWT and PBMT	Ankle Range of Motion (ROM)	12.18 degrees	Standard Deviation 4.04

Primary

Ankle Range of Motion (ROM)

Quantitative function in range of motion (ROM)

Time frame: 6 Months

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Ankle Range of Motion (ROM)	15.75 degrees	Standard Deviation 7.64
PT + Photobiomodulation Therapy (PBMT)	Ankle Range of Motion (ROM)	10.22 degrees	Standard Deviation 3.46
PT + Shockwave Therapy (SWT)	Ankle Range of Motion (ROM)	10.67 degrees	Standard Deviation 4.32
PT + SWT and PBMT	Ankle Range of Motion (ROM)	11.60 degrees	Standard Deviation 5.12

Primary

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).

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Cross-sectional Area	0.64 cm	Standard Deviation 0.11
PT + Photobiomodulation Therapy (PBMT)	Cross-sectional Area	0.65 cm	Standard Deviation 0.15
PT + Shockwave Therapy (SWT)	Cross-sectional Area	0.69 cm	Standard Deviation 0.29
PT + SWT and PBMT	Cross-sectional Area	0.85 cm	Standard Deviation 0.27

Primary

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).

Time frame: 12-week

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Cross-sectional Area	0.67 cm	Standard Deviation 0.42
PT + Photobiomodulation Therapy (PBMT)	Cross-sectional Area	0.71 cm	Standard Deviation 0.21
PT + Shockwave Therapy (SWT)	Cross-sectional Area	0.62 cm	Standard Deviation 0.22
PT + SWT and PBMT	Cross-sectional Area	1.50 cm	Standard Deviation 1.39

Primary

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).

Time frame: 6-month

Arm	Measure	Value (MEAN)	Dispersion
Physical Therapy (PT) Only	Cross Sectional Area	0.76 cm	Standard Deviation 0.38
PT + Photobiomodulation Therapy (PBMT)	Cross Sectional Area	0.74 cm	Standard Deviation 0.13
PT + Shockwave Therapy (SWT)	Cross Sectional Area	0.70 cm	Standard Deviation 0.33
PT + SWT and PBMT	Cross Sectional Area	0.80 cm	Standard Deviation 0.31

Primary