Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Study Overview
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Brief Summary
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Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p<0.05). In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

Detailed Description
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See brief summary

Official Title
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Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Corticosteroids
* Device: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years and older, but <75 years; VAS for pain > 30mm; Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3); Failure of conservative therapy of more than one month; Written informed consent; Available for the duration of the investigation. Exclusion Criteria: Previous surgery in the same region; Current other problem(s) in the affected extremity; Diabetes mellitus; Patient who received a local (CS) injection within 3 months from the baseline visit; Allergic or hypersensitive to CS or HA; Patients suffering (chronic) low back pain with or without sciatic pain; Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence >1); Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>Injectable hyaluronic acid. | Device: Hyaluronic acid<br>* Intra-bursal injection<br>* Other names: SportVis;|
| Active Comparator: Corticosteroids<br>Injectable corticosteroids. | Drug: Corticosteroids<br>* Intra-bursal injection<br>* Other names: Depo-Medrol 40mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for pain |  | 26 weeks after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 6, 12, 26 weeks | 
| VAS for pain |  | 6 and 12 weeks after administration |