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Combination Therapies for Achilles Tendinopathy
N/A
Recruiting
Led By Jeremy D Schroeder
Research Sponsored by Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month
Awards & highlights
Study Summary
This trial aims to determine the best way to reduce pain and improve function in people with Achilles tendinopathy: standard of care PT, PT + PBMT, PT + SWT, or PT + SWT & PBMT.
Who is the study for?
Active duty US Armed Forces members aged 18-64 with a clinical diagnosis of mid-portion Achilles tendinopathy can join. They must be able to read English, commit to a 3-week treatment and 6-month follow-up. Exclusions include recent treatments like dry needling or shockwave therapy, tattoos in the treatment area, pacemaker use, certain heart diseases or medications, current sciatica symptoms, tendon injuries/surgery, other pain studies participation, pregnancy plans during the study period.Check my eligibility
What is being tested?
The trial is testing how well different combinations of physical therapy (PT) work for Achilles tendinopathy. It compares standard PT alone versus PT with low-level laser therapy (photobiomodulation), high-energy acoustic wave therapy (shockwave), and both therapies combined. The aim is to find out which method best improves function and reduces pain.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of treatment from shockwave or photobiomodulation therapies such as redness or swelling. There's also a risk of bruising from physical manipulation during PT sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ankle range of motion
Cross Sectional area
Cross-sectional area
+11 moreTrial Design
4Treatment groups
Active Control
Group I: PT + Shockwave Therapy (SWT)Active Control2 Interventions
The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment described above. Twice a week, 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 study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check- in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, however, this is not feasible, it may be conducted virtually; the second check-in of the week may occur virtually or in-person.
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.
Group II: PT + SWT and PBMTActive Control3 Interventions
The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described above. 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).
Group III: Physical Therapy (PT) OnlyActive Control1 Intervention
Participants in the PT only arm will follow the PT program outlined above. Twice a week 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 study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in person.
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).
Group IV: PT + Photobiomodulation Therapy (PBMT)Active Control2 Interventions
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.
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Who is running the clinical trial?
Musculoskeletal Injury Rehabilitation Research for Operational ReadinessLead Sponsor
3 Previous Clinical Trials
350 Total Patients Enrolled
The Geneva FoundationOTHER
30 Previous Clinical Trials
12,234 Total Patients Enrolled
1 Trials studying Achilles Tendinopathy
16 Patients Enrolled for Achilles Tendinopathy
Fort Belvoir Community HospitalFED
13 Previous Clinical Trials
2,096 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished the Silbernagel protocol for Achilles tendinopathy recently.I have had shock wave therapy on my Achilles in the last 3 months.I have a heart condition that could be worsened by shock wave therapy.I experience ongoing or recurring pain, numbness, or tingling in my lower body due to sciatica.I had a leg injury in the last 3 months that needed a doctor's care.I have undergone dry needling in the last 4 weeks.I haven't had PRP, steroid injections, or prolotherapy in the last 3 months.I have Achilles tendon pain near where it attaches to the heel.I have nerve damage that affects my ability to feel pain.I have had an Achilles tendon tear or surgery on it.I have a rheumatic disease or foot and ankle arthritis, but not Achilles tendinopathy.I am between 18 and 64 years old.I can commit to a 3-week treatment and 6-month follow-up.I have been diagnosed with mid-portion Achilles tendinopathy.I am not taking medications that make me sensitive to heat or light.
Research Study Groups:
This trial has the following groups:- Group 1: PT + Shockwave Therapy (SWT)
- Group 2: PT + SWT and PBMT
- Group 3: Physical Therapy (PT) Only
- Group 4: PT + Photobiomodulation Therapy (PBMT)
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.
Do I meet the prerequisites to join this experiment?
"In order to be considered for the study, applicants must possess a diagnosis of achilles tendinopathy and fall within the age range 18-64. The research is searching for roughly 160 individuals that meet these criteria."
Answered by AI
Is this trial still accepting participants?
"According to the data available on clinicaltrials.gov, enrollment is still open for this medical trial that was initially posted on January 26th 2023 and recently updated in February 27th 2023."
Answered by AI
Is there an age cap on the individuals who may participate in this clinical experiment?
"This study only accepts participants aged 18 to 64. There are similarly structured trials available for individuals under the age of majority, and 54 studies which target seniors above the age of 65."
Answered by AI
What is the aggregate number of participants participating in this trial?
"Affirmative. The information available on clinicaltrials.gov states that this investigation is actively recruiting. First shared online on January 26th, 2023 and last amended a month later, it seeks 160 volunteers to come from one location for participation."
Answered by AI
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