Patellofemoral Pain SyndromeNCT03101956
Lumbar Manipulation for Hip and Muscle Strength
A study testing Lumbar Spine Manipulation in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- What is being tested?
- Lumbar Spine Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 21 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
- Anterior knee pain with squatting
- Agreed to be in the study and signed the informed consent document
Who cannot join
- Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
- Osteoporosis or recent fracture of the hip or spinal joints
- Spinal or hip joint surgery or prosthesis
- Knee surgery on the affected knee within the last 6 months
- Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
- Nervous system disease or disorder
Show all 13Show fewer
- Pregnant
- Lumbar nerve root compression (any of the following signs present)
- Positive straight leg raise (SLR) test less than 45°
- Marked paresis involving a major muscle group of the lower extremity
- Diminished, and asymmetric (lower than uninvolved side), lower extremity
- muscle stretch reflex
- Diminished or absent sensation to pinprick in any lower extremity dermatome
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial
The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions
Read the detailed description
This prospective, double-blind, randomized control trial clinical will use a multigroup pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within the biopsychosocial model and the International Classification of Functioning, Disability and Health (ICF) framework, this research will measure the outcomes between patellofemoral pain syndrome (PFPS), the health condition, and contextual factors, particularly personal factors. It will address personal factors such as gender and age but will not address environmental factors. This research includes tests and measures of two of the three levels of human functioning, or domains, impairments to body functions and structures and activity limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat range of morion (ROM) is an activity limitation-level measure.
- Being tested
- Lumbar Spine Manipulation, Lumbar Spine Manipulation Placebo
- Keywords
- Spine 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.
Lumbar Spine ManipulationProcedure or surgery
Also called Sidelying lumbosacral thrust joint manipulation
- The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
Lumbar Spine Manipulation PlaceboProcedure or surgery
Also called Sidelying lumbosacral thrust joint manipulation placebo
The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
| Study group | Role | What they receive |
|---|---|---|
| L/S Manipulation Study Group | Experimental | Not described Receives: Procedure: Lumbar Spine Manipulation |
| Control Group | Active comparator | Not described Receives: Procedure: Lumbar Spine Manipulation Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength using dynamometer
Hand-held dynamometry involves the use of a dynamometer that is held by a tester and applied to the tested segment of a patient's body.
Measured: 1 Day
Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems
Measured: 1 Day
Secondary outcomes (1)
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest
Numeric Pain Rating Scale
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Mar 2017
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
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.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D'Agati, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101956
- Sponsor's protocol ID
- 16-01718
- Status last verified
- Nov 2020
- First submitted
- 30 Mar 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Manipulation for Improving Hip and Knee Muscle Strength in Patients With Patellofemoral Pain Syndrome - A Randomized, Placebo-Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03101956
- Acronym / sponsor ID
- 16-01718
- Keywords
- Spine Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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 aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions
Detailed description
This prospective, double-blind, randomized control trial clinical will use a multigroup pretest-posttest control design with 1 treatment arm and 1 control arm. Interpreted within the biopsychosocial model and the International Classification of Functioning, Disability and Health (ICF) framework, this research will measure the outcomes between patellofemoral pain syndrome (PFPS), the health condition, and contextual factors, particularly personal factors. It will address personal factors such as gender and age but will not address environmental factors. This research includes tests and measures of two of the three levels of human functioning, or domains, impairments to body functions and structures and activity limitations. Muscle strength testing is an impairment-level measure and pain-free deep squat range of morion (ROM) is an activity limitation-level measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L/S Manipulation Study Group | Experimental | Procedure: Lumbar Spine Manipulation |
| Control Group | Active comparator | Procedure: Lumbar Spine Manipulation Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
- Anterior knee pain with squatting
- Agreed to be in the study and signed the informed consent document
Key exclusion criteria (13 listed)
- Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
- Osteoporosis or recent fracture of the hip or spinal joints
- Spinal or hip joint surgery or prosthesis
- Knee surgery on the affected knee within the last 6 months
- Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
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 |
|---|---|---|
| Lumbar Spine ManipulationAlso: Sidelying lumbosacral thrust joint manipulation• The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself. | Procedure or surgery | L/S Manipulation Study Group |
| Lumbar Spine Manipulation PlaceboAlso: Sidelying lumbosacral thrust joint manipulation placeboThe subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself. | Procedure or surgery | Control Group |
Primary outcome
Muscle Strength using dynamometer
Time frame: 1 Day
Hand-held dynamometry involves the use of a dynamometer that is held by a tester and applied to the tested segment of a patient's body.
Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Time frame: 1 Day
The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems
1 secondary outcome
Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest
Time frame: 1 Day
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 3 Nov 2020.
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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.
Michael D'Agati, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Spine Manipulation in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by NYU Langone Health 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 13 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 3 Nov 2020. 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?
Muscle Strength using dynamometer (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 3 Nov 2020.