Patellofemoral Pain SyndromeNCT01975311
Effect of Lower Back Treatment in People With Patellofemoral Pain Syndrome.
A study testing Lumbopelvic Manipulation and Passive lumbar spine flexion and extension 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 determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Lumbopelvic Manipulation and Passive lumbar spine flexion and extension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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
- No healthy volunteers
- Adult
Who may be able to join
- Insidious onset of symptoms of non-traumatic origin.
- Pain with patellar facet palpation or compression.
- anterior or retropatellar knee pain during at least two of the following activities: (a) ascending stairs, (b) descending stairs, (c) kneeling, (d) squatting, (e) hopping, (f) running, (j) jumping, (h) prolonged sitting for more than 20 minutes.
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.
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: Effect of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity, Pain Intensity, and Functional Activity in People With Patellofemoral Pain Syndrome.
The purpose of this study is to determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities as well as reduce the knee pain intensity and improve the functional activities in people with anterior knee pain.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Lumbopelvic Manipulation, Passive lumbar spine flexion and extension
- 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 non-specific lumbopelvic thrust manipulation
Passive lumbar spine flexion and extensionOther
Passive lumbar spine flexion and extension without reaching the physiological end feel for 1 min from a side lying position.
| Study group | Role | What they receive |
|---|---|---|
| Lumbopelvic Manipulation | Experimental | Participants in this group will receive lumboplevic manipulation twice within a week. Receives: Other: Lumbopelvic Manipulation |
| Passive lumbar spine flexion and extension | Placebo comparator | Participants in this group will receive passive lumbar spine flexion and extension for 1 min twice within a week. Receives: Other: Passive lumbar spine flexion and extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG) of the hip and knee muscle
EMG unit will be used to study the hip and knee muscle activities.
Measured: The EMG data will be collected within one week for all participants in both groups.
Secondary outcomes (2)
Pain Visual Analog Scale (VAS)
Measured: The pain VAS data will be collected within one week for all participants in both groups
Lower Extremity Functional Scale (LEFS)
Measured: The LEFS data will be collected within one week for all participants in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975311
- Sponsor's protocol ID
- 17284
- Status last verified
- Nov 2014
- First submitted
- 28 Oct 2013
- 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
- Effect of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity, Pain Intensity, and Functional Activity in People With Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT01975311
- Acronym / sponsor ID
- 17284
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Nov 2013 (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 determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities as well as reduce the knee pain intensity and improve the functional activities in people with anterior knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic Manipulation | Experimental | Other: Lumbopelvic ManipulationParticipants in this group will receive lumboplevic manipulation twice within a week. |
| Passive lumbar spine flexion and extension | Placebo comparator | Other: Passive lumbar spine flexion and extensionParticipants in this group will receive passive lumbar spine flexion and extension for 1 min twice within a week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Insidious onset of symptoms of non-traumatic origin.
- Pain with patellar facet palpation or compression.
- anterior or retropatellar knee pain during at least two of the following activities: (a) ascending stairs, (b) descending stairs, (c) kneeling, (d) squatting, (e) hopping, (f) running, (j) jumping, (h) prolonged sitting for more than 20 minutes.
Key exclusion criteria (6 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 non-specific lumbopelvic thrust manipulation | Other | Lumbopelvic Manipulation |
| Passive lumbar spine flexion and extensionPassive lumbar spine flexion and extension without reaching the physiological end feel for 1 min from a side lying position. | Other | Passive lumbar spine flexion and extension |
Primary outcome
Electromyography (EMG) of the hip and knee muscle
Time frame: The EMG data will be collected within one week for all participants in both groups.
EMG unit will be used to study the hip and knee muscle activities.
2 secondary outcomes
Pain Visual Analog Scale (VAS)
Time frame: The pain VAS data will be collected within one week for all participants in both groups
Lower Extremity Functional Scale (LEFS)
Time frame: The LEFS data will be collected within one week for all participants in both groups.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Passive lumbar spine flexion and extension 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 3 inclusion and 6 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. Some participants in this study may receive a placebo. 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) of the hip and knee muscle (time frame: The EMG data will be collected within one week for all participants in both groups.). 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.