- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03029260
Effects of Nervous System Mobilization
Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Aveiro, Portugal, 3810-193
- School of Health Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- naïve to nervous system mobilization;
Exclusion Criteria:
- Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Neural mobilization - tension
It is anticipated that 30 participants will be in this group.
They will receive tension type neural mobilization of the peroneal nerve in the dominant limb.
This will consist of positioning the lower limb with inversion and plantar flexion of the ankle, extension of the knee and maximum flexion of the hip without pain.
A physiotherapists will move the hip from this maximum position of flexion in direction to extension (for example if the participants reaches 80º of flexion the mobilization will be between 40º and 80º of flexion).
Each participant will receive four series of 10 mobilizations with 1 minute rest between series.
|
Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures. The intervention will be delivered in one session only. |
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Aktiv komparator: Neural mobilization - sliding
It is anticipated that 30 participants will be in this group.
They will receive sliding neural mobilization of the peroneal nerve in the dominant limb.
Each participant will receive four series of 10 mobilizations with 1 minute rest between series of the following combination of movement: from ankle dorsiflexion, knee extension and hip extension to ankle plantarflexion, knee and hip flexion.
|
Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures. The intervention will be delivered in one session only. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Range of motion of the Straight Leg Raising test
Tidsramme: Baseline
|
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
|
Baseline
|
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Range of motion of the Straight Leg Raising test
Tidsramme: Approximately 45 minutes after baseline measurements
|
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
|
Approximately 45 minutes after baseline measurements
|
|
Range of motion of the Straight Leg Raising test
Tidsramme: At least 24 hours after baseline measurements
|
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
|
At least 24 hours after baseline measurements
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heat threshold
Tidsramme: Baseline
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
Baseline
|
|
Heat threshold
Tidsramme: Approximately 45 minutes after baseline measurements
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
Approximately 45 minutes after baseline measurements
|
|
Heat threshold
Tidsramme: At least 24 hours after baseline measurements
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
At least 24 hours after baseline measurements
|
|
Cold threshold
Tidsramme: Baseline
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
Baseline
|
|
Cold threshold
Tidsramme: Approximately 45 minutes after baseline measurements
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
Approximately 45 minutes after baseline measurements
|
|
Cold threshold
Tidsramme: At least 24 hours after baseline measurements
|
This is measured with a QSense instrument, which has thermode that is attached to the skin.
The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it.
The temperature perceived is the test result.
|
At least 24 hours after baseline measurements
|
|
Pressure pain threshold
Tidsramme: Baseline
|
This is measured using a pressure pain algometer.
Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain.
The amount of pressure that the participants perceives as being painful is the test result.
|
Baseline
|
|
Pressure pain threshold
Tidsramme: Approximately 45 minutes after baseline measurements
|
This is measured using a pressure pain algometer.
Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain.
The amount of pressure that the participants perceives as being painful is the test result.
|
Approximately 45 minutes after baseline measurements
|
|
Pressure pain threshold
Tidsramme: At least 24 hours after baseline measurements
|
This is measured using a pressure pain algometer.
Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain.
The amount of pressure that the participants perceives as being painful is the test result.
|
At least 24 hours after baseline measurements
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Anabela Silva, PhD, University of Aveiro
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NSM01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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