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

NCT ID: NCT04576611

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2020-02-11

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

face-to-face protocol

Intervention Type: OTHER

The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).

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.

Group Type: EXPERIMENTAL

self-managed protocol

Intervention Type: OTHER

Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Interventions

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).

Intervention Type: OTHER

self-managed protocol

Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

University of the Balearic Islands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolina Sitges, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Balearic Islands, Department of Psychology

Locations

University of the Balearic Islands

Palma, Balearic Islands, Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16550447 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28359011 (View on PubMed)

Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.

Reference Type: BACKGROUND

PMID: 29138049 (View on PubMed)

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Reference Type: BACKGROUND

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Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.

Reference Type: BACKGROUND

PMID: 21989632 (View on PubMed)

Sitges C, Terrasa JL, Garcia-Dopico N, Segur-Ferrer J, Velasco-Roldan O, Crespi-Palmer J, Gonzalez-Roldan AM, Montoya P. An Educational and Exercise Mobile Phone-Based Intervention to Elicit Electrophysiological Changes and to Improve Psychological Functioning in Adults With Nonspecific Chronic Low Back Pain (BackFit App): Nonrandomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Mar 15;10(3):e29171. doi: 10.2196/29171.

Reference Type: DERIVED

PMID: 35289758 (View on PubMed)

Other Identifiers

PSI2015-66295

Identifier Type: -

Identifier Source: org_study_id