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

Hip Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390103
• Other study ID #: 711-2010
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: April 18, 2013
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Pain

Intervention

Other:
• Assessment following hip injection
Assessment to evaluate the effect of the hip injection on biomechanics.

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the immediate biomechanical effect in patients that receive a hip 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.	No
Secondary	Oswestry Hip Pain Disability Questionnaire	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	No
Secondary	Medical Outcomes Study (MOS) Short-Form Health Survey (SF-12)	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	No
Secondary	10 centimeter Visual Analog Scale (VAS)	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	No
Secondary	Pain Provocative Maneuvers	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	No