Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
29. januar 2020 oppdatert av: Cid André Fidelis de Paula Gomes, University of Nove de Julho
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world.
The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA.
To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20).
12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus.
For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group.
A significance level of 5% will be adopted.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
São Paulo, Brasil, 01504-001
- University of Nove de Julho
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Exclusion Criteria:
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
- Cancer;
- Diabetes any acute adverse health condition;
- Signs of hip OA;
- Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Exercises with blood flow restriction
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
|
Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
|
|
Eksperimentell: Exercises with blood flow restriction + photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
|
Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
|
|
Placebo komparator: Blood flow restriction exercises + placebo photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
|
Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Placebo photobiomodulation - photobiomodulation device turned off.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional pain
Tidsramme: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
|
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
|
Stiffness
Tidsramme: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
|
Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
|
Physical functional
Tidsramme: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
|
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensity of pain
Tidsramme: Change from Baseline in The Numerical rating pain scale at 12 weeks
|
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
|
Change from Baseline in The Numerical rating pain scale at 12 weeks
|
|
Functional capacity for sitting and standing
Tidsramme: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
|
sitting-rising test
|
Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
|
|
Level of pressure pain
Tidsramme: Change from Baseline in ThePressure Pain Threshold at 12 weeks
|
Pressure Pain Threshold in the knee with algometer dynamometer.
|
Change from Baseline in ThePressure Pain Threshold at 12 weeks
|
|
Muscle skin temperature
Tidsramme: Change from Baseline in the muscle skin temperature at 12 weeks
|
Infrared thermography, thermal imaging.
Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
|
Change from Baseline in the muscle skin temperature at 12 weeks
|
|
Maximum voluntary isometric contraction
Tidsramme: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
|
A portable dynamometer will be used to assess muscle contraction.
|
Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. november 2020
Primær fullføring (Forventet)
1. november 2020
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
27. januar 2020
Først innsendt som oppfylte QC-kriteriene
27. januar 2020
Først lagt ut (Faktiske)
30. januar 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20123719.1.0000.5511
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .