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Treatment Group: ESWT Arm for Post-Traumatic Stress Disorder (PTOA Knee Trial)

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

* Diagnosis of mild to moderate PTOA based on clinical diagnosis and confirmation with radiographic evidence by a medical professional prior to study enrollment

* Previous ACL reconstruction using patellar-tendon-bone autograft in the knee with PTOA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 4-month follow up with intermediate measure at 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.

Eligible Conditions

Post-Traumatic Stress Disorder
Knee Arthritis
Anterior Cruciate Ligament Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 4-month follow up with intermediate measure at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 4-month follow up with intermediate measure at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 4-month follow up with intermediate measure at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary study objectives

Bioimpedance

Biomarkers of oxidative stress and inflammation

Biomechanics

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group: ESWT ArmExperimental Treatment1 Intervention

All participants will review the exercise program prior to randomization and receiving treatment. Participants in the ESWT group will receive ESWT. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Radial and focused shockwave will be delivered to the knee and lower leg landmarks. The energy settings that will be used are consistent with mild to moderate ESWT which are commonly used in clinical practice to treat knee OA. During the ESWT treatment, a curtain will obscure participants from viewing their leg to blind them from treatment they are receiving. Standard protocol for the ESWT procedure will be followed, including safety assessment and monitoring. Additionally, the patient will be prescribed a post-ESWT exercise protocol that is part of the standard of care, which will be reviewed prior to first treatment and before treatment allocation is decided to minimize risk of bias.

Group II: Control Group: Sham ESWT ArmPlacebo Group1 Intervention

All participants will review the exercise program prior to randomization and receiving sham ESWT treatment. The standard operating procedures for ESWT will be followed and will include review of procedure protocol and post-procedure care. Participants will come into the office for three treatment visits separated by seven days +/- 7 days to account for ongoing challenges for respiratory illness and scheduling/traveling conflicts. After collecting baseline variables and after blood is drawn, they will receive sham ESWT administered by trained research personnel, using the OrthoPlus Ultra 100/radial D-Actor and Duolith SD1 T-Top focused shockwave devices. The device will be placed on the same landmarks as that of the ESWT treatment group; however, no shockwaves will be administered; rather, an audio recording that mimics the sound of shockwave will be played. A curtain will obscure participants from viewing their knee and the device to blind them from treatment they are receiving.

0 / 7Eligibility criteria met