CompletedNot Applicable

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

United States46 participantsStarted 2022-08-29

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Calf Raises Performed to Fatigue and Inability to Continue

Timeframe: Difference from 0-3 months

Ultrasound Measurements in Change of Cross Sectional Area

Timeframe: Difference from 0-3 months

Victorian Institute of Sports Assessment (VISA-A) Questionnaire

Timeframe: change from baseline to 3 month follow-up measure

Trial details

NCT IDNCT04725513

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

Results submitted2025-10-06

View on ClinicalTrials.gov More Achilles Tendinopathy trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Calf Raises Performed to Fatigue and Inability to Continue

Timeframe: Difference from 0-3 months

Ultrasound Measurements in Change of Cross Sectional Area

Timeframe: Difference from 0-3 months

Victorian Institute of Sports Assessment (VISA-A) Questionnaire

Timeframe: change from baseline to 3 month follow-up measure