- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01390103
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
Intervention / Treatment
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
-
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Florida
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Gainesville, Florida, United States, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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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.
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Assessment to evaluate the effect of the hip injection on biomechanics.
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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.
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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.
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Baseline, Within 1 hour of hip injection, 2 weeks post-injection
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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
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Baseline, Within 1 hour of injection, 2 weeks post-injection
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10 centimeter Visual Analog Scale (VAS)
Time Frame: Baseline, Within 1 hour of injection, 2 weeks post-injection
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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.
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Baseline, Within 1 hour of injection, 2 weeks post-injection
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Pain Provocative Maneuvers
Time Frame: Baseline, Within 1 hour of injection, 2 weeks pos-injection
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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
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Baseline, Within 1 hour of injection, 2 weeks pos-injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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