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

NCT04576611 | Completed

• 1 other identifier: PSI2015-66295
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Mobile Applications; Muscle and Stretching Exercises; Physical Exercise; Behavior

Outcome Measures

Primary Outcomes (3)

• Cognitive functioning assessment.

  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)

  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).

  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.

Secondary Outcomes (9)

• Balance

  Up to 12 weeks.

• Range of movement

  Up to 12 weeks.

• Clinical pain

  Up to 12 weeks.

• Pain interference

  Up to 12 weeks.

• Affective symptoms (Mood)

  Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Study Arms (2)

face-to-face

EXPERIMENTAL

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.

Other: face-to-face protocol

self-managed

EXPERIMENTAL

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.

Other: self-managed protocol

Interventions

face-to-face protocol OTHER

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

face-to-face

self-managed protocol OTHER

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

self-managed

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

University of the Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

Related Publications (8)

• Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.

  PMID: 16095934 BACKGROUND

• van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.

  PMID: 16550447 BACKGROUND

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 BACKGROUND

• Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.

  PMID: 28359011 BACKGROUND

• 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.

  PMID: 29138049 BACKGROUND

• Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.

  PMID: 25090974 BACKGROUND

• 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.

  PMID: 21989632 BACKGROUND

• 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.

  PMID: 35289758 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Sitges, PhD

  University of Balearic Islands, Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: October 6, 2020
• Study Start: March 6, 2019
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)