Navigator vs Standard Needle Injection for Hip

Study Overview
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Brief Summary
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The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.

Official Title
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Phase II Study of Navigator vs Standard Needle Injection for Hip

Conditions
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Hip Pain Etiology Unknown

Intervention / Treatment
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* Drug: Celestone
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, ≥18 years of age, of any race or ethnicity; Capable of completing self-administered questionnaires; Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months; Candidate for a hip injection; Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee. Subjects are able to understand and speak English Exclusion Criteria: History of intra-articular injection within the last 3 months prior to the injection procedure; Complex regional pain syndrome; History of prior hip surgery; History of substance abuse; Known history of hypersensitivity to local anesthetics of the amide type; Contraindicated for Celestone (betamethasone sodium phosphate); Contraindicated for Lidocaine Hydrochloride; Is a prisoner or ward of the state; Are unable to meet the treatment and follow up protocol requirements.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Manual Needle Injection<br>2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon | Drug: Celestone<br>* 2cc<br>* Other names: Betamethasone Sodium Phosphate;Drug: Lidocaine<br>* 5cc<br>|
| Experimental: Navigator Injection<br>2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon | Drug: Celestone<br>* 2cc<br>* Other names: Betamethasone Sodium Phosphate;Drug: Lidocaine<br>* 5cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Pain as measured by VAS for both treatment groups |  | From 1 week to 12 weeks post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Patient Satisfaction |  | From 1 week to 12 weeks post-injection | 
| Drug Preparation Time |  | From 1 week to 12 weeks post-injection | 
| Hip Pain and Function |  | From 1 week to 12 weeks post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Pain, Hip Injection, Hip Fracture, Hip Bursitis, Hip Arthritis, Hip Sciatica