Patellofemoral Pain SyndromeNCT01637480
Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity
A study testing Lumbopelvic manipulation in people with Patellofemoral Pain Syndrome, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Lumbopelvic manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2014
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- history of spine, hip or knee surgery
- history of hip pathology or other knee condition
- current significant injury of any lower extremity joints
- pregnancy
- sign of nerve root compression
- osteoporosis or history of compression fracture
- Age- and gender- matched control participants will be recruited if they have no signs or symptoms of patellofemoral pain syndrome and have none of the exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Woman's University, School of Physical Therapy - Dallas Campus
Dallas, Texas, 75235
About this study
Official title: Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity in People With and Without Patellofemoral Pain Syndrome
The purpose of this study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in people without anterior knee pain.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Lumbopelvic manipulation
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic manipulationOther
High-velocity-low-amplitude thrust manipulation of the lumbopelvic region
| Study group | Role | What they receive |
|---|---|---|
| Patellofemoral Pain Syndrome | Experimental | Participants with Patellofemoral Pain Syndrome Receives: Other: Lumbopelvic manipulation |
| Healthy control | Active comparator | Age- and gender-matched participants without Patellofemoral Pain Syndrome Receives: Other: Lumbopelvic manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG)
Electromyography (EMG) onset time of the gluteus maximus, gluteus medius, vastus medialis oblique, and vastus lateralis muscles.
Measured: The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention.
Secondary outcomes (1)
Pain Visual Analog Scale (VAS)
Pain Visual Analog Scale (VAS) is a 100 mm continuous line between two end-points. The left end-point represents "no pain" and the right end-point represents the "worst pain imaginable".
Measured: The Pain Visual Analog Scale (VAS) will be assessed before and 45 min after the lower back treatment (lumbopelvic manipulation) for participants in the patellofemoral pain syndrome group on Day 2 only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ammar M Al Abbad, Master, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637480
- Sponsor's protocol ID
- 16882
- Status last verified
- Nov 2014
- First submitted
- 25 Jun 2012
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity in People With and Without Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT01637480
- Acronym / sponsor ID
- 16882
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jul 2012 (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 study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in people without anterior knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellofemoral Pain Syndrome | Experimental | Other: Lumbopelvic manipulationParticipants with Patellofemoral Pain Syndrome |
| Healthy control | Active comparator | Other: Lumbopelvic manipulationAge- and gender-matched participants without Patellofemoral Pain Syndrome |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- history of spine, hip or knee surgery
- history of hip pathology or other knee condition
- current significant injury of any lower extremity joints
- pregnancy
- sign of nerve root compression
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 |
|---|---|---|
| Lumbopelvic manipulationHigh-velocity-low-amplitude thrust manipulation of the lumbopelvic region | Other | Healthy control, Patellofemoral Pain Syndrome |
Primary outcome
Electromyography (EMG)
Time frame: The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention.
Electromyography (EMG) onset time of the gluteus maximus, gluteus medius, vastus medialis oblique, and vastus lateralis muscles.
1 secondary outcome
Pain Visual Analog Scale (VAS)
Time frame: The Pain Visual Analog Scale (VAS) will be assessed before and 45 min after the lower back treatment (lumbopelvic manipulation) for participants in the patellofemoral pain syndrome group on Day 2 only.
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 12 Jan 2015.
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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.
Ammar M Al Abbad, Master principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbopelvic manipulation in people with Patellofemoral Pain Syndrome, run by Texas Woman's University 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 0 inclusion and 7 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 12 Jan 2015. 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?
Electromyography (EMG) (time frame: The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention.). 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 12 Jan 2015.