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Combined Therapies for Achilles Tendinopathy
N/A
Waitlist Available
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 months
Awards & highlights
Study Summary
This trial is testing three different treatments for Achilles Tendinopathy. The treatments are physical therapy, shockwave therapy, and photobiomodulation.
Who is the study for?
This trial is for people with non-insertional Achilles tendinopathy who primarily run, averaging at least 10 miles per week, and have a VISA-A score below 80. It's not for those with insertional tendinopathy, pregnant women, or individuals currently in physical therapy for over four weeks. Also excluded are those who've had shockwave therapy or injections recently, have rheumatological diseases, symptomatic foot arthritis, other running injuries besides Achilles tendinopathy, or are on certain medications.Check my eligibility
What is being tested?
The study compares the effectiveness of three treatments: physical therapy (exercises), shockwave therapy (sound waves to promote healing), and photobiomodulation (light therapy) in managing Achilles tendon pain away from the heel bone. Participants will be randomly assigned to one treatment but can switch after three months if they choose.See study design
What are the potential side effects?
Potential side effects may include temporary pain or discomfort at the treatment site from physical exercises or shockwaves. Light therapy might cause skin irritation. The severity of side effects varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mid-portion Achilles tendinopathy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calf raises to fatigue
Ultrasound measurements
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Shockwave Therapy and Physical TherapyExperimental Treatment2 Interventions
Group II: Photobiomodulation, Shockwave Therapy and Physical TherapyExperimental Treatment3 Interventions
Group III: Physical Therapy OnlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photobiomodulation Therapy
2023
Completed Phase 2
~50
Shockwave Therapy
2018
N/A
~70
Find a Location
Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,969 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant.I have Achilles tendon pain where it attaches to the heel.I have had an Achilles tendon tear in the past.I have been diagnosed with mid-portion Achilles tendinopathy.I have a diagnosed rheumatic disease or a foot/ankle condition.I am currently taking oral steroids or antibiotics from the fluoroquinolone class.Before getting injured, you used to run as your main physical activity and you would run an average of 10 miles or more each week.I have been in physical therapy for my condition for over 4 weeks.I have not had any injections in the last 3 months.I have had shock wave therapy on my Achilles in the last 3 months.My symptoms started less than 3 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Therapy Only
- Group 2: Shockwave Therapy and Physical Therapy
- Group 3: Photobiomodulation, Shockwave Therapy and Physical Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are taking part in this research endeavor?
"Correct. On clinicaltrials.gov, it is evident that this research initiative commenced on August 29th 2022 and its details have been recently amended on September 19th 2022. The study requires 60 participants to be recruited from 1 location."
Answered by AI
Is this trial enrolling new participants?
"According to the details posted on clinicaltrials.gov, this research endeavour is actively seeking out participants; it was originally uploaded on August 29th 2022 and most recently updated nine days later."
Answered by AI
Does the research encompass people of all ages, or are there any age restrictions?
"This medical research requires patients to be aged 18-65. For those outside this range, there are three trials available for minors and fifty seven investigations open to seniors."
Answered by AI
Is there a way for me to participate in this medical research?
"To be eligible for inclusion in this trial, applicants must have achilles tendinopathy and fall within the age bracket of 18 to 65. A total of 60 participants are being accepted into the study."
Answered by AI
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