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Completed

NCT Number: NCT04725513

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

This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

About this study

This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
  • Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
  • VISA-A <80 at baseline to be eligible

Exclusion criteria

  • Less than 3 months of symptoms
  • Primary insertional Achilles tendinopathy
  • Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
  • Have received SWT within the past 3 months to their Achilles
  • Prior injection within 3 months
  • Currently enrolled in PT for more than 4 weeks for their condition
  • Women who are pregnant.
  • known history of Achilles tendon tear
  • currently taking oral steroid or fluoroquinolone class of antibiotics

Treatment and study plan

Shockwave therapy

Device

Participants will receive shockwave therapy once a week for three weeks

photobiomodulation therapy

Device

Participants will receive photobiomodulation therapy twice a week for three weeks

Physical Therapy

Other

Participants will enroll in physical therapy and complete an at-home exercise protocol

Primary outcomes

  1. Calf Raises Performed to Fatigue and Inability to Continue

    Time frame: Difference from 0-3 months

    Calf raises performed to fatigue and inability to continue

  2. Ultrasound Measurements in Change of Cross Sectional Area

    Time frame: Difference from 0-3 months

    Changes in the cross-sectional area measured on ultrasound

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

    Time frame: change from baseline to 3 month follow-up measure

    Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Jan 12, 2026

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

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

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

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