Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain

Completed

• Conditions: Hip Pain
• Interventions: Other: Assessment following hip injection

• Registration Number: NCT01390103
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Osteoarthritis patients with hip pain requiring hip injection
• Receiving hip injection
• BMI < 35

Exclusion Criteria

• BMI > 35
• severely impaired intellectual capacity
• dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Assessment following the hip injection	Assessment following hip injection	Assessment to evaluate the effect of the hip injection on biomechanics.

Primary Outcome Measures

Name	Time	Method
Determine the immediate biomechanical effect in patients that receive a hip injection.	The short-term biomechanical effects of the hip will be evaluated within 1 hour of the patient receiving the injection.	The biomechanical assessment of gait will consist of walking on a gait mat. The mat is a specialized pressure sensor system. Prior to data collection, each participant will walk across the mat three times for acclimation. The first assessment will include a walk at a self-selected, comfortable pace across the mat, repeated three times. The second assessment will include walking as quickly as possible, also repeated three times.

Secondary Outcome Measures

Name	Time	Method
Oswestry Hip Pain Disability Questionnaire	Baseline, Within 1 hour of hip injection, 2 weeks post-injection	Oswestry Hip Pain Disability Questionnaire. This a standard, well validated questionnaire to assess disability caused by hip pain. The questionnaire is a 10-item scale, ranging from 0 to 100%, to obtain a score for functional disability caused by hip pain.
Medical Outcomes Study (MOS) Short-Form Health Survey (SF-12)	Baseline, Within 1 hour of injection, 2 weeks post-injection	The SF-12 is a global health assessment questionnaire ranging from 0 to 100%, to score self-experienced health related to quality of life. Items are grouped into two domains from which an overall summary score, a physical component score and a mental component score can be derived. A high score on each of the scales reflects a high level of self-experienced health
10 centimeter Visual Analog Scale (VAS)	Baseline, Within 1 hour of injection, 2 weeks post-injection	Hip pain is a symptom that affects the overall Quality Of Life. Hip pain intensity will be self-assessed by a 10 cm visual analogue scale with terminal descriptors (anchors of 0 cm = no pain; 10 cm = worst possible pain). The VAS is an accepted outcome measure for chronic pain conditions.
Pain Provocative Maneuvers	Baseline, Within 1 hour of injection, 2 weeks pos-injection	All patients currently undergoing hip injections receive a basic physical exam including patient specific provocative maneuvers both before and after the injection. The loss of pain after injection of a local anesthetic is part of the routine treatment algorithm and the results will be correlated with other outcome measures

Trial Locations

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States