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NCT05751785

Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

Completed NA Results posted Last updated 22 July 2025
What this trial tests

NA trial testing Physical Therapy in Achilles Tendinopathy in 48 participants. Completed in 14 November 2024.

Timeline
13 February 2023
Primary endpoint
14 November 2024
14 November 2024

Quick facts

Lead sponsorMusculoskeletal Injury Rehabilitation Research for Operational Readiness
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment48
Start date13 February 2023
Primary completion14 November 2024
Estimated completion14 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Who can join

Adults 18 to 64, any sex, with Achilles Tendinopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Physical Therapy (PT) Only37.55± 15.56
PT + Photobiomodulation Therapy (PBMT)43.82± 18.88
PT + Shockwave Therapy (SWT)36.08± 20.55
PT + SWT and PBMT46.92± 13.17
Victorian Institute of Sports Assessment - Achilles (VISA-A) Primary · 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

GroupValue95% CI
Physical Therapy (PT) Only56.33± 19.86
PT + Photobiomodulation Therapy (PBMT)63.90± 12.91
PT + Shockwave Therapy (SWT)50.17± 16.92
PT + SWT and PBMT58.30± 18.25
Victorian Institute of Sports Assessment - Achilles (VISA-A) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only61.11± 23.80
PT + Photobiomodulation Therapy (PBMT)64± 14.75
PT + Shockwave Therapy (SWT)54.09± 17.35
PT + SWT and PBMT63.20± 19.59
Victorian Institute of Sports Assessment - Achilles (VISA-A) Primary · 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

GroupValue95% CI
Physical Therapy (PT) Only69.33± 17.67
PT + Photobiomodulation Therapy (PBMT)61.10± 20.63
PT + Shockwave Therapy (SWT)58.10± 16.21
PT + SWT and PBMT68.40± 15.90
Victorian Institute of Sports Assessment - Achilles (VISA-A) Primary · 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

GroupValue95% CI
Physical Therapy (PT) Only67.50± 19.51
PT + Photobiomodulation Therapy (PBMT)76.11± 20.37
PT + Shockwave Therapy (SWT)61.22± 18.21
PT + SWT and PBMT69± 18.99
Lower Extremity Functional Scale (LEFS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only47.91± 14.47
PT + Photobiomodulation Therapy (PBMT)50.10± 19.64
PT + Shockwave Therapy (SWT)46.75± 16.87
PT + SWT and PBMT59.55± 12.90
Lower Extremity Functional Scale (LEFS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only51.33± 18.76
PT + Photobiomodulation Therapy (PBMT)60.90± 19
PT + Shockwave Therapy (SWT)47.75± 17.58
PT + SWT and PBMT57.70± 17.60
Lower Extremity Functional Scale (LEFS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only60.78± 12.60
PT + Photobiomodulation Therapy (PBMT)62.11± 15.71
PT + Shockwave Therapy (SWT)55.27± 14.43
PT + SWT and PBMT64.30± 9.68
Lower Extremity Functional Scale (LEFS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only65.11± 14.47
PT + Photobiomodulation Therapy (PBMT)65.30± 15.30
PT + Shockwave Therapy (SWT)54.10± 18.18
PT + SWT and PBMT60.40± 18.58
Lower Extremity Functional Scale (LEFS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only62.38± 17.09
PT + Photobiomodulation Therapy (PBMT)64.89± 19.14
PT + Shockwave Therapy (SWT)62.33± 15.53
PT + SWT and PBMT67.10± 10.94
Defense and Veteran's Pain Rating Scale (DVPRS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only4.27± 1.66
PT + Photobiomodulation Therapy (PBMT)3.50± 2.87
PT + Shockwave Therapy (SWT)5.58± 2.29
PT + SWT and PBMT3.27± 1.96
Defense and Veteran's Pain Rating Scale (DVPRS) Primary · 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.

GroupValue95% CI
Physical Therapy (PT) Only2.67± 1.33
PT + Photobiomodulation Therapy (PBMT)2.50± 2.50
PT + Shockwave Therapy (SWT)4.17± 2.15
PT + SWT and PBMT2.60± 1.80

Adverse events — posted to ClinicalTrials.gov

Time frame: All participants were evaluated for adverse events at each follow-up visit during their participation in the study (at 3 weeks, 6 weeks, 3 months, and 6 months), and all reportable events, regardless of severity, were reported to the Principal Investigator and the IRB.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Physical Therapy (PT) Only
Serious: 4/11 (36%)
Deaths: 0/11
PT + Photobiomodulation Therapy (PBMT)
Serious: 2/10 (20%)
Deaths: 0/10
PT + Shockwave Therapy (SWT)
Serious: 2/12 (17%)
Deaths: 0/12
PT + SWT and PBMT
Serious: 0/12 (0%)
Deaths: 0/12

Serious adverse events (8 terms)

ReactionSystemPhysical Therapy (PT) OnlyPT + Photobiomodulation Th…PT + Shockwave Therapy (SWT)PT + SWT and PBMT
Shoulder SurgerySurgical and medical procedures
Neck SurgerySurgical and medical procedures
URIRespiratory, thoracic and mediastinal disorders
Achilles PainMusculoskeletal and connective tissue disorders
RhabdomyolysisMusculoskeletal and connective tissue disorders
AllergySkin and subcutaneous tissue disorders
Sprained AnkleInjury, poisoning and procedural complications
Emergency DepartmentSurgical and medical procedures
Other adverse events (65 terms — click to expand)

ReactionSystemPhysical Therapy (PT) OnlyPT + Photobiomodulation Th…PT + Shockwave Therapy (SWT)PT + SWT and PBMT
Achilles Pain in non-study legMusculoskeletal and connective tissue disorders
Cervical PainMusculoskeletal and connective tissue disorders
GoutMusculoskeletal and connective tissue disorders
Heel PainMusculoskeletal and connective tissue disorders
Pain in AchillesMusculoskeletal and connective tissue disorders
Knee InjuryInjury, poisoning and procedural complications
Aggravated AchillesMusculoskeletal and connective tissue disorders
Food poisonInjury, poisoning and procedural complications
Shoulder PainMusculoskeletal and connective tissue disorders
Foot and Achilles SorenessMusculoskeletal and connective tissue disorders
Increased Knee PainMusculoskeletal and connective tissue disorders
Sore CalfMusculoskeletal and connective tissue disorders
Running increases PainMusculoskeletal and connective tissue disorders
Cortisone InjectionSurgical and medical procedures
Aggravated AchillesMusculoskeletal and connective tissue disorders
Increased soreness from standingMusculoskeletal and connective tissue disorders
Increased soreness in AchillesMusculoskeletal and connective tissue disorders
Plantar fascia in non-study legMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Left Knee InjuryInjury, poisoning and procedural complications
InjuryInjury, poisoning and procedural complications
Treatment for PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Increased left Achilles PainMusculoskeletal and connective tissue disorders
Increased SorenessMusculoskeletal and connective tissue disorders
Increased Achilles PainMusculoskeletal and connective tissue disorders
Achilles PainMusculoskeletal and connective tissue disorders
Ankle SorenessMusculoskeletal and connective tissue disorders
Injection in the eyeEye disorders
SorenessMusculoskeletal and connective tissue disorders
Soreness, tenderness, and stiffness in a AchillesMusculoskeletal and connective tissue disorders
Increased SorenessMusculoskeletal and connective tissue disorders
Increased Achilles PainMusculoskeletal and connective tissue disorders
Increased PainMusculoskeletal and connective tissue disorders
Soreness in CalfMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Shoulder Surgery, Neck Surgery, URI, Achilles Pain, Rhabdomyolysis, Allergy, Sprained Ankle, Emergency Department.

Data from ClinicalTrials.gov NCT05751785 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Physical Therapy

Trials testing the same drug.

Other recruiting trials for Achilles Tendinopathy

Currently open trials in the same condition.

Other Musculoskeletal Injury Rehabilitation Research for Operational Readiness trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05751785.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing