Achilles Tendinopathy
Conditions
Brief summary
The purpose of this study is to compare the effectiveness of ultrasound guided brisement, brisement without ultrasound guidance and standard conservative treatment in patients who have been diagnosed with Achilles tendinosis. We are asking you to take part in this research study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed with Achilles tendinosis. About 100 people will take part in this research study, all at Brigham and Women's Hospital (BWH). To our knowledge, there has been very little research in the efficacy of the addition of briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our results will show which method is the most effective conservative treatment for Achilles tendinosis. This information will help doctors make decisions in the future.
Interventions
BIOLOGICALBrisement injection
An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.
PROCEDUREPhysical Therapy
Patients will receive a prescription for physical therapy.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will analyze the data as group 1 and 2, not knowing which group received what treatment.
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.
Exclusion criteria
* Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VISA - A | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| PROMIS | 6 weeks, 3 months, 6 months, 1 year |
| VAS Pain Scale | Weekly for 3 months, 6 months, 1 year |
Countries
United States
Outcome results
None listed