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

April 18, 2013 updated by: University of Florida
The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential subjects will be all patients receiving a hip injection for hip pain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Assessment following the hip injection
Assessment to evaluate the effect of the hip injection on biomechanics.
Assessment to evaluate the effect of the hip injection on biomechanics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the immediate biomechanical effect in patients that receive a hip injection.
Time Frame: 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.
The short-term biomechanical effects of the hip will be evaluated within 1 hour of the patient receiving the injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Hip Pain Disability Questionnaire
Time Frame: 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.
Baseline, Within 1 hour of hip injection, 2 weeks post-injection
Medical Outcomes Study (MOS) Short-Form Health Survey (SF-12)
Time Frame: 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
Baseline, Within 1 hour of injection, 2 weeks post-injection
10 centimeter Visual Analog Scale (VAS)
Time Frame: 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.
Baseline, Within 1 hour of injection, 2 weeks post-injection
Pain Provocative Maneuvers
Time Frame: 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
Baseline, Within 1 hour of injection, 2 weeks pos-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: MaryBeth Horodyski, PhD, University of Florida Departmen of Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 711-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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