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

31 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

59

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 59 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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).
Expérimental: 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.
Autre: self-managed protocol
Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cognitive functioning assessment.
Délai: 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)
Délai: 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).
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Balance
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of the Balearic Islands

Collaborateurs

Ministerio de Economía y Competitividad, Spain

Les enquêteurs

  • Chercheur principal: Carolina Sitges, PhD, University of Balearic Islands, Department of Psychology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 mars 2019

Achèvement primaire (Réel)

11 février 2020

Achèvement de l'étude (Réel)

11 février 2020

Dates d'inscription aux études

Première soumission

10 juillet 2020

Première soumission répondant aux critères de contrôle qualité

29 septembre 2020

Première publication (Réel)

6 octobre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PSI2015-66295

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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