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

University of the Balearic Islands

Status: Completed

Conditions: Low Back Pain

Treatments: Other: self-managed protocol; Other: face-to-face protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04576611

PSI2015-66295

Details and patient eligibility

About

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.

Full description

The objectives of this study are:

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. 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:

This intervention based on education and physical exercise will increase PPT and improve selective attention. 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. The intervention performed with BackFit App will be as effective as that supervised by a health professional.

Enrollment: 59 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

face-to-face

Experimental group

Description:

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.

Treatment:

Other: face-to-face protocol

self-managed

Experimental group

Description:

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.

Treatment:

Other: self-managed protocol