Hip PainNCT01390103
Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain
An observational study of Hip Pain, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Pain
- What is being tested?
- Assessment following hip injection
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential subjects will be all patients receiving a hip injection for hip pain.
Who may be able to join
- Osteoarthritis patients with hip pain requiring hip injection
- Receiving hip injection
- BMI < 35
Who cannot join
- BMI > 35
- severely impaired intellectual capacity
- dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.
- Conditions
- Hip Pain
- Being tested
- Assessment following hip injection
- Keywords
- hip pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment following hip injectionOther
Assessment to evaluate the effect of the hip injection on biomechanics.
| Study group | Role | What they receive |
|---|---|---|
| Assessment following the hip injection | Assessment to evaluate the effect of the hip injection on biomechanics. Receives: Other: Assessment following hip injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The short-term biomechanical effects of the hip will be evaluated within 1 hour of the patient receiving the injection.
Secondary outcomes (4)
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.
Measured: Baseline, Within 1 hour of hip injection, 2 weeks post-injection
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
Measured: Baseline, Within 1 hour of injection, 2 weeks post-injection
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.
Measured: Baseline, Within 1 hour of injection, 2 weeks post-injection
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
Measured: Baseline, Within 1 hour of injection, 2 weeks pos-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MaryBeth Horodyski, PhD, Study director, University of Florida Departmen of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390103
- Sponsor's protocol ID
- 711-2010
- Status last verified
- Apr 2013
- First submitted
- 5 Jul 2011
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain
- ClinicalTrials.gov ID
- NCT01390103
- Acronym / sponsor ID
- 711-2010
- Conditions
- Hip Pain
- Keywords
- hip pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to determine the effect of hip injections on hip biomechanics in patients with hip pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment following the hip injection | – | Other: Assessment following hip injectionAssessment to evaluate the effect of the hip injection on biomechanics. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be all patients receiving a hip injection for hip pain.
Key inclusion criteria (3 listed)
- Osteoarthritis patients with hip pain requiring hip injection
- Receiving hip injection
- BMI < 35
Key exclusion criteria (3 listed)
- BMI > 35
- severely impaired intellectual capacity
- dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment following hip injectionAssessment to evaluate the effect of the hip injection on biomechanics. | Other | Assessment following the hip injection |
Primary outcome
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.
4 secondary outcomes
Oswestry Hip Pain Disability Questionnaire
Time frame: 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
10 centimeter Visual Analog Scale (VAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryBeth Horodyski, PhD study director
University of Florida Departmen of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.