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LOw Level of Activity (LOLA): Education and Exercise-based Intervention for Low Back Pain (LOLA)

31 marca 2021 zaktualizowane przez: University of the Balearic Islands

Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)

Chronic pain of moderate to severe intensity occurs in 19% of adult Europeans. Non-specific low-back pain is one of the most prevalent symptoms and the main cause of disability in industrialized countries, generating significant public health expenditure on health and occupational care. The combination of pain neurophysiology education and therapeutic exercise has shown positive effects in patients with chronic non-specific low back pain. Mobile health tools (mHealth) are proposed as a cost-effective alternative to continuously record the daily activities of patients and to provide rapid feedback to users and clinicians, reducing visits to clinics. A 4-week (8-session) education and exercise-based intervention will be carried out in a group of patients with non-specific chronic low back pain using two modalities: (1) face-to-face guided by a health professional or (2) self-managed through BackFit App. The sample will be divided into two groups and will be evaluated before (pre), after (post) and 3 months (follow-up) after the intervention.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The objectives of this study are:

  1. To assess the influence of a 4-week (8 sessions) intervention based on education (about pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and cognitive functioning (selective attention), as primary variable outcomes, and on physical condition (balance and range of movement), affective and cognitive symptoms (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain interference and self-reported clinical pain, as secondary variable outcomes, in patients with non-specific chronic low back pain.
  2. To evaluate the effectiveness of a mobile health application developed by researchers (BackFit App) to carry out the intervention, in comparison with a supervised intervention by a health professional.

The hypotheses of the study are:

  1. This intervention based on education and physical exercise will increase PPT and improve selective attention.
  2. This intervention will also improve physical condition, self-reported clinical pain, affective and cognitive symptoms and pain interference presented by patients with chronic low back pain.
  3. The intervention performed with BackFit App will be as effective as that supervised by a health professional.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

59

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
    • Illes Balears
      • Palma, Illes Balears, Hiszpania, 07122
        • University of the Balearic Islands

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 59 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Subjects between 18 and 59 years, with non-specific low back pain for more than 6 weeks and which have experienced at least 3 episodes of low back pain lasting more than 1 week during the year prior to the study, and, at the time of evaluation and/or intervention, presenting pain of mild/moderate intensity (not exceeding 5 out of 10 in a Visual Analogue Scale (VAS)).

Exclusion Criteria:

  • High functional impairment compromising activities such as walking, sitting or getting up from a chair.
  • Pain at the time of evaluation and/or intervention greater than 5 (out of 10) in a VAS.
  • Presence of irradiated pain (sciatic type) or referred to lower extremities.
  • History of spine surgery, spinal or pelvic fracture
  • Hospitalization for serious trauma or injuries due to traffic accidents.
  • History of osteoarthritis in the lower extremities.
  • History of any systematic diseases with involvement of the locomotor system.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: face-to-face
A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using face-to-face modality guided by a health professional.
Inny: face-to-face protocol
The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).
Eksperymentalny: self-managed
A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using self-managed modality through BackFit App.
Inny: self-managed protocol
Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cognitive functioning assessment.
Ramy czasowe: Up to 4 weeks.
Cognitive functioning was assessed by recording electroencephalographic activity during a computerized version of the Flanker task, which measures selective attention, under two experimental conditions: congruent flanks (arrows) with the target (pointing in the same direction as the central arrow) and incongruent (pointing the opposite direction).Regarding Resting EEG a Fast Fourier Transform (FFT) analysis has been made (delta, theta, "Alpha" and beta 1, 2 and 3. The EEG during the "Flanker task" was analyzed by means of a "Cluster-based analysis". Primary outcome measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Up to 4 weeks.
Heart Rate Variability (HRV)
Ramy czasowe: Up to 4 weeks.
Heart Rate Variability (HRV) has been analyzed from ECG data. Primary outcome Measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Up to 4 weeks.
Pressure pain thresholds (PPT).
Ramy czasowe: Up to 12 weeks.
To evaluate Pressure pain thresholds (PPT )(with a maximum of 5kg/cm2) will be applied pressure on the erector spinae and index finger with an algometer (area 1cm2). Primary outcome measures were recorded in a counterbalanced order and were measured at baseline, 4 and 12 weeks.
Up to 12 weeks.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Balance
Ramy czasowe: Up to 12 weeks.
Mono and bipedal static balance will be measured with the Wii balance board. Measurements will be performed after 15 minutes of rest once the subject arrives at baseline, 4 and 12 weeks.
Up to 12 weeks.
Range of movement
Ramy czasowe: Up to 12 weeks.
Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and 12 weeks.
Up to 12 weeks.
Clinical pain
Ramy czasowe: Up to 12 weeks.
Clinical pain will be measured with Visual Analog Scale (VAS) (0-10cm) This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater pain intensity.
Up to 12 weeks.
Pain interference
Ramy czasowe: Up to 12 weeks.
Pain interference data will be collected with the Spanish version of Oswestry Disability Index (ODI) (0-100%). This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater functional disability.
Up to 12 weeks.
Affective symptoms (Mood)
Ramy czasowe: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Mood, often associated to chronic pain, will be assessed by the Spanish versions of Profile of Mood States (POMS) questionnaire.

The POMS questionnaire (Ranges from 0-200) assesses six mood subscales: tension-anxiety (0-36), anger-hostility (0-48), vigor (0-32), fatigue (0-28), depression (0-60) and confusion (0-28).

High vigor scores reflect a good mood or emotion. Low scores in the other subscales reflect a good mood or emotion
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Affective symptoms (anxiety)
Ramy czasowe: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Anxiety, often associated to chronic pain, will be assessed by the State Trait Anxiety Inventory (STAI) questionnaire. State (0-30) and Trate (0-30). Higher scores indicates greater anxiety.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (catastrophizing)
Ramy czasowe: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Other cognitive symptoms, such as catastrophyzing, will be assessed using the Spanish version of Pain Catastrophizing Scale (PCS)(Ranges from 0-52), a 13-item scale where low scores show little catastrophization, and high values, high catastrophization.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (fear-avoidance beliefs)
Ramy czasowe: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Other cognitive symptoms, such as fear-avoidance beliefs will be also assessed using Fear Avoidance Beliefs Questionnaire (FABQ).(ranges from 0-96) Higher scores indicate more strongly held fear avoidance beliefs.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (kinesiophobia)
Ramy czasowe: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Other cognitive symptoms, such as kinesiophobia (or fear of movement) will be also assessed using the spanish version of Tampa Scale for Kinesiophobia (TSK).

It consists of 11 items scored from 1 (strongly disagree) to 4 (strongly agree). The higher the score, the higher the degree of kinesiophobia.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of the Balearic Islands

Współpracownicy

Ministerio de Economía y Competitividad, Spain

Śledczy

  • Główny śledczy: Carolina Sitges, PhD, University of Balearic Islands, Department of Psychology

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 marca 2019

Zakończenie podstawowe (Rzeczywisty)

11 lutego 2020

Ukończenie studiów (Rzeczywisty)

11 lutego 2020

Daty rejestracji na studia

Pierwszy przesłany

10 lipca 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 września 2020

Pierwszy wysłany (Rzeczywisty)

6 października 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 kwietnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PSI2015-66295

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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