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Completed

NCT Number: NCT01390103

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

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

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Key information

Conditions

Hip Pain

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment following hip injection

Other

Assessment to evaluate the effect of the hip injection on biomechanics.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2011
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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