- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02854774
Neural Mechanisms of Muscle Control in Individuals With Knee Pain
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90049
- University of Southern California
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pain reduction measured using a visual analog scale (VAS) for knee pain
Tidsram: 4 weeks and 6 months
|
Compared to baseline
|
4 weeks and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Brain function measured using fMRI
Tidsram: 4 weeks
|
Compared to baseline
|
4 weeks
|
Muscle activation assessed with electromyographic (EMG) recordings
Tidsram: 4 weeks
|
Activation of knee and hip muscles
|
4 weeks
|
Knee kinematics assessed with 3-dimensional motion capture
Tidsram: 4 weeks
|
Body movement during a jumping task
|
4 weeks
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HS-16-00038
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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