- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02854774
Neural Mechanisms of Muscle Control in Individuals With Knee Pain
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Rationale: Two prior randomized controlled trials (RCT) have highlighted the importance of hip muscle activation and strengthening as a treatment strategy for patellofemoral pain (Khayambashi, 2014; Khayambashi, 2012). Here, we propose a pilot study to acquire preliminary data to power a larger study to reveal the neural mechanism underlying the effectiveness of this intervention to promote its evidence-based incorporation into clinical practice.
Intervention: 4 weeks of quadriceps muscle versus 4 weeks of hip strengthening exercises.
Purpose: To determine changes in brain functional connectivity related to pain reduction induced by the strengthening exercises.
Study population: Males and females with a history of unilateral knee pain.
Methodology: Functional magnetic resonance imaging (fMRI) will be used to quantify functional connectivity of brain regions related to hip muscle activation. Functional connectivity will be quantified before (pre) and after (post) 4 weeks of quadricep or hip muscle strengthening exercises.
Arms: As above, there are 2 arms. 4 weeks of quadriceps strengthening exercises (Arm 1) versus 4 weeks of hip strengthening exercises (Arm 2).
Outcomes: At the pre and post-intervention sessions in each participant, we will quantify the brain functional connectivity between hip muscle motor cortex and the 1) thalamus, 2) basal ganglia, and 3) insula, and 4) the periaqueductal gray. We will also quantify self-report of pain and biomechanical function of the knee and hip.
Follow-up: A six month follow-up is planned for this pilot study.
Analysis Plan and Statistics: Functional connectivity of hip muscle motor cortex will be extracted using standard statistical software for brain mapping. A repeated measures ANOVA will be used to assess change in functional connectivity in the hip and knee group. Pain decreases in the both groups will be quantified and reported.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90049
- University of Southern California
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pain located specifically around the patellofemoral articulation (vague or localized).
- Readily reproducible pain (3 out of 10 on a visual analog scale) with at least 2 of the following functional activities commonly associated with PFP: stair ascent or descent, squatting, kneeling, prolonged sitting, or isometric quadriceps contraction.
- Reports of pain greater than 3 months duration.
Exclusion Criteria:
- Previous history of knee surgery.
- History of traumatic patellar dislocation.
- Neurological involvement that would influence gait.
- Contraindications to MR imaging: implanted electronic devices (i.e. pacemaker), or metallic implants (i.e. aneurysm clips, fixation screws).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Knee muscle activation/strengthening
4 weeks of exercises focused on activation and strengthening of knee extensor muscles.
|
Activation of either muscles activating the knee or hip.
|
|
Aktiv komparator: Hip muscle activation/strengthening
4 weeks of exercises focused on activation and strengthening of hip extensor muscles.
|
Activation of either muscles activating the knee or hip.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain reduction measured using a visual analog scale (VAS) for knee pain
Tidsramme: 4 weeks and 6 months
|
Compared to baseline
|
4 weeks and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Brain function measured using fMRI
Tidsramme: 4 weeks
|
Compared to baseline
|
4 weeks
|
|
Muscle activation assessed with electromyographic (EMG) recordings
Tidsramme: 4 weeks
|
Activation of knee and hip muscles
|
4 weeks
|
|
Knee kinematics assessed with 3-dimensional motion capture
Tidsramme: 4 weeks
|
Body movement during a jumping task
|
4 weeks
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
- Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HS-16-00038
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Patellofemoralt smertesyndrom
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University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)AfsluttetPatellofemoralt smertesyndrom | Patellofemoral smerte (PFPS) | Patellofemoral smerte | Patellofemoral Pain, PfpForenede Stater
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Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Cardiff Metropolitan UniversityAfsluttetPatellofemoral Pain, PfpDet Forenede Kongerige
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Lauren EricksonAmerican College of Sports MedicineAfsluttetPatellofemoralt syndromForenede Stater
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