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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Assessment following the hip injection
Assessment to evaluate the effect of the hip injection on biomechanics.
Other: Assessment following hip injection
Assessment to evaluate the effect of the hip injection on biomechanics.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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