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Effect of Physiotherapeutic Interventions on Quality of Life in Patients With Chronic Low Back Pain. (Study 2) (CLBP)

11. oktober 2018 oppdatert av: Robbert van Amstel, Vrije Universiteit Brussel

Effects of a Multimodal Intervention Based on the 4 Times T Orthopedic Rehabilitation Decision Tree on the Quality of Life in Non-specific Chronic Low Back Pain.

The purpose of this study is to investigate the effect on QoL, PI and the AROM° in patients with non-specific chronic low back pain. This after following an episode of 6 weeks 2 times a week physiotherapeutic back rehabilitation according to the 4 times T method by orthopaedic disorder ® (4MTOR®). The results in this research will be analyzed and reported. In this study, 7 dependent variables will be independently examined relative to 2 independent variables.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Ukjent

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Detaljert beskrivelse

The purpose of this small RCT is to investigate whether this is a good research design and procedure to measure the effect on QoL, PI and the AROM° in patients with NSP-CLBP. This after following an episode of 6 weeks twice a week physiotherapeutic back rehabilitation according to the 4MTOR®. The results in this research will also be analysed and reported. The research design and procedure will be useful when this small RCT shows that the 4MTOR® can positively influence the QoL,PI and the AROM° with a p value <α = 0.05 in NSP-CLBP patients.

Primary variable is the QoL these are measured using the EQ-5D-3L which consists of the EQ-5D-index and the EQ visual analogue scale (EQ-VAS). The EQ-5D-3L questionnaire is developed by Euroqol Group. Secondary outcome measures are the AROM° of the active trunk flexion and trunk extension measured with a bubble inclinometer. Also, the PI will be scored by the patient during flexion and extension by means of the Verbal Pain Scale scaled 0-10 (VRS). The outcomes will be measured within 12 weeks in all participants. The measurements take place during week 0 the baseline measurement (W0), week 3 the intermediate measurement (W3) week 7 the post measurement (W7) and finally week 12 follow up measurement (W12). All participants were fully informed for the research and agreed by signing the "informed consent" . The research was approved by the Committee of Medical Ethics University Hospital University of Brussels, B.U.N. 143201627110.

Inclusion and exclusion criteria. Participants are included when they meet the following criteria: NSP-CLBP from 12 weeks and longer that are continuously present (with and without recurrent complaints), Age between 20 and 60 years and not yet treated by the 4MTOR®. Participants are excluded when they meet the following criteria: Radiological disturbing pain beyond knee, extremely serious neurological disorder symptoms, overall malaise, spinal cord malignancy, unexplained weight loss, prolonged corticosteroid use, osteoporotic vertebral fracture, spondylitis ankylopoetics, spinal stenosis, rheumatic arthritis, vertebral fracture and severe deformity of the spinal cord.

Recruitment. Patients recruitment: The subjects are recruited from orthopedic hospitals departments in Utrecht the Netherlands. Participants will be asked if they want to refer NSP-CLBP patients for this research and by advertisement in an Dutch-language newspaper (Appendix II). Also, NSP-CLBP patients who applied for physical therapy were asked if they wanted to participate in this research. A call form has been prepared for this purpose (Appendix III). All subjects were asked if they would like to participate in this research. The subjects has been authorized to perform medical physiotherapeutic treatment. This has been done by signing a statement of agreement, as previously stated. Personal data will not be included in this research and are protected by researchers and the Committee of Medical Ethics University Hospital University of Brussels.

Therapist recruitment Experimental intervention group: This physiotherapist has been educated and qualified in the KNGF accredited multimodal intervention according to the 4MTOR®. The physiotherapist has at least 2 years of work experience with the use of the 4MTOR® decision tree.

Therapist recruitment SHAM intervention group: This is Health Care registered physiotherapist and has at least 3 years work experience and is familiar with the KNGF Low Back pain, 2013 guidelines (KNGF_LBP). Both therapists were informed about their work protocol and have agreed to the implementation of the interventions by signing an informed consent.

In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises).

The participants in the Sham group (SGR) received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique was applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze32 and Evidence Based Practice Therapy (Appendix III). The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®.

Primary:

- EQ 5d-5L questionnaire

Secondary:

Thoracolumbo-pelvic flexion, inclinometry Thoracolumbo-pelvic extension, inclinometry (note 5 x for measurement errors) Isolated lumbar flexion, inclinometry Verbal pain score flexion, VRS 0-10 Verbal pain score extension, VRS 0-10

Research design. This research is a one way, Mixed, real experimental design One way design (Independent Groups variables). Mixed Design: Baseline Week 0 - Week 3 - Week 7-Week 12 Within groups: difference in time Between groups: difference between groups.

The sample analysis was performed for the RM-ANOVA using the Gpower © program. The RM-ANOVA power analysis with the following values: Power .95, Alpha 0.50, Sample size effect f2 = .24 resulted in a minimum of 40 participants. 20% will be added on the total N=48 for the possibility of dropouts. The CLBP participants are divided into two groups, each group holding twenty-five participants.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Forventet)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
50

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studer Kontakt Backup

  • Navn: Peter P Vaes, PhD
  • Telefonnummer: +32 +322 477 43 26
  • E-post: pvaes@vub.be

Studiesteder

  • Belgia
    • Brussels
      • Jette, Brussels, Belgia, 1090
        • Rekruttering
        • Peter Vaes
        • Ta kontakt med:

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

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

20 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Participants are included when they meet the following criteria:

  • NSP-CLBP from 12 weeks and longer that are continuously present (with and without recurrent complaints)
  • Age between 20 and 60 years
  • Not yet treated by the 4MTOR®.

Exclusion Criteria:

Participants are excluded when they meet the following criteria:

  • Radiological disturbing pain beyond knee
  • Extremely serious neurological disorder symptoms
  • Overall malaise
  • Spinal cord malignancy
  • Unexplained weight loss
  • Prolonged corticosteroid use
  • Osteoporotic vertebral fracture
  • Spondylitis ankylopoetics
  • Spinal stenosis
  • Rheumatic arthritis
  • Vertebral fracture
  • Severe deformity of the spinal cord

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: Faktoriell oppgave
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: experimental group (EGR)

Physical therapy intervention.

In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises).
Annen: Fysioterapi intervensjon

I forsøksgruppen (EGR) vil behandlingsmetoden 4MTOR® bli brukt for LBP. Denne 4MTOR® bruker følgende trinn i et beslutningstre: T1-testing (fysioterapeutisk undersøkelse), T2-utløsning (manuelle teknikker), T3-taping (elastisk tape) og T4-trening (medisinske rehabiliteringsøvelser).

Deltakerne i SGR mottok en falsk multimodal fysioterapeutisk intervensjon som kontrollintervensjon, der sham-teknikk ble brukt. Intervensjonene bestod i å kombinere Sham manuelle intervensjoner, elastiske tape i henhold til Kaze32 og Evidence Based Practice Therapy (vedlegg III). Protokollen i SGR følger lignende trinn: testing, taping, triggering og trening som 4MTOR®.
Sham-komparator: Sham group (SGR)

Physical therapy intervention.

The participants in the SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze and Evidence Based Practice Therapy. The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®.
Annen: Fysioterapi intervensjon

I forsøksgruppen (EGR) vil behandlingsmetoden 4MTOR® bli brukt for LBP. Denne 4MTOR® bruker følgende trinn i et beslutningstre: T1-testing (fysioterapeutisk undersøkelse), T2-utløsning (manuelle teknikker), T3-taping (elastisk tape) og T4-trening (medisinske rehabiliteringsøvelser).

Deltakerne i SGR mottok en falsk multimodal fysioterapeutisk intervensjon som kontrollintervensjon, der sham-teknikk ble brukt. Intervensjonene bestod i å kombinere Sham manuelle intervensjoner, elastiske tape i henhold til Kaze32 og Evidence Based Practice Therapy (vedlegg III). Protokollen i SGR følger lignende trinn: testing, taping, triggering og trening som 4MTOR®.

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
First measurment: Quality of life, EQ-5D-3L-index
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)

The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p<α=0.05.

Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3)
Second measurment: Quality of life, EQ-5D-3L-index
Tidsramme: Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)

The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p<α=0.05..

Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
Third measurment: Quality of life, EQ-5D-3L-index
Tidsramme: Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)

The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p<α=0.05.

Within time: W0-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
Fourth measurment: Quality of life, EQ-5D-3L-index
Tidsramme: Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)

The EQ-5D-3L-index will analyze the participants Quality of life (QoL). Each question in the EQ-5D-3L-index includes one dimension of QoL: mobility, self-care, daily activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels ( having no problems, having some or moderate problems, being unable to do/having extreme problems) and gets a separate score.The scores can be combined in combination with an assessment of the health status they represent, this rating is expressed in weight or utility (1,000 = no problems at all) to (-0,329= extreme problems). Description of the QoL can be transformed into a QoL assessment by means of a formula. These ratings are based on judgments of the general population of all possible combinations of QoL on the different dimensions. An improvement in quality of life will be assumed when p<α=0.05.

Within time: W7-W12 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
First measurment: EQ- visual analogue scale (VAS)
Tidsramme: Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W3 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Time Frame: Timespad registration: Week 0/baseline measurement (W0) - week 3/intermediate measurement (W3)
Second measurment: EQ- visual analogue scale (VAS)
Tidsramme: Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W3-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 3/intermediate measurement (W3), week 7/ post measurement (W7)
Third measurment: EQ- visual analogue scale (VAS)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W0-W7 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 0/baseline measurement (W0)- Week 7/ post measurement (W7)
Fourth measurment: EQ- visual analogue scale (VAS)
Tidsramme: Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)
The EQ VAS records the respondent's self-rated health on a 20 cm vertical (0-100 score), visual analogue scale with endpoints labelled 'the best health (100) you can imagine' and 'the worst health you can imagine (0) '. This information can be used as a quantitative measure of health as judged by the individual respondents. An improvement in quality of life will be assumed when p<α=0.05. For the EQ-VAS we used the minimum important change (MIC) for VAS 15 points Within time: W7-W12 Between groups: EGR versus SGR. The results are shown for all variables in a table.
Timespad registration: Week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
AROM° thoracolumbar-pelvic flexion (TLPF)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

AROM° Thoracolumbar-pelvic flexion. The inclinometer placed on L1 / T12 with the tape between the inclinometer arcus and was set to 0°. During the test, the investigator kept the inclinometer on L1 / T12 while instructing the subject to bend forward with the arms in hanging position.

The changes in our variables will be analyzed within time and between groups.

Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
AROM° thoracolumbar- pelvic extension (TLPE)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

AROM° Thoracolumbar-pelvic extension. The inclinometer placed on L1 / T12 with the tape between the inclinometer arcus and was set to 0 °. During the test, the investigator kept the inclinometer on L1 / T12 while instructing the subject to put his hands on his pelvis and bend backward.

The changes in our variables will be analyzed within time and between groups.

Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
AROM° isolated lumbar flexion(ILF)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

AROM° Isolated lumbar flexion test. The inclinometer was moved to labeled S1 / S2 and the inclinometer was set to 0 °. During the test, the investigator held the inclinometer on S1 / S2 while instructing the subject to bend forward. The formula ∑▒〖T12/L1〗 - S1/S2 was used.

The changes in our variables will be analyzed within time and between groups.

Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Pain intensity flexion (0-10)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Before the participant gave a PI number to the active flexion or extension, the VRS scale was shown. Thereafter the movement was performed as described in the protocol. After completing the active flexion or extension, the participant gave a VRS score regarding the PI.

The changes in our variables will be analyzed within time and between groups.

Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)
Pain intensity extension (0-10)
Tidsramme: Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

. Before the participant gave a PI number to the active flexion or extension, the VRS scale was shown. Thereafter the movement was performed as described in the protocol. After completing the active flexion or extension, the participant gave a VRS score regarding the PI.

The changes in our variables will be analyzed within time and between groups.

Within time: W0-W3, W0-W7, W3-W7, and W7-W12. Between groups: EGR versus SGR. The results are shown for all variables in a table. The analysis for all variables is significant when p<α=0.05.
Timespad registration: Week 0/baseline measurement (W0), week 3/intermediate measurement (W3), week 7/ post measurement (W7) and week 12 follow up measurement (W12)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
Vrije Universiteit Brussel

Samarbeidspartnere

Samarbeidspartnere

En annen organisasjon enn sponsoren som gir støtte til en klinisk studie. Denne støtten kan omfatte aktiviteter knyttet til finansiering, design, implementering, dataanalyse eller rapportering.
The EuroQol Research Foundation
This research is supported by the Fysio Science Institute® and is a non-profit institution.
Committee of Medical Ethics University Hospital University of Brussels, B.U.N. 143201627110.
Ethias liability policy: 45.147.458, insurance for the experiment on human subjects.

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Studieleder: Peter P Vaes, PhD, University of Brussels, faculty of Rehabilitation science and physical therapy, faculty of Pharmacy and medicine, Brussels, Belgium

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 (Faktiske)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
31. oktober 2017

Primær fullføring (Forventet)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
31. desember 2018

Studiet fullført (Forventet)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
31. desember 2018

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
2. oktober 2017

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
12. oktober 2017

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
13. oktober 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
12. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
11. oktober 2018

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • EBP4MTOR02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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. .

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Forhold

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