NCT04576611

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of the Balearic Islands · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	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).
OTHER	self-managed protocol	Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Timeline

• Start date: 2019-03-06
• Primary completion: 2020-02-11
• Completion: 2020-02-11
• First posted: 2020-10-06
• Last updated: 2021-04-02

Locations

1 site across 1 country: Spain