Clinical trial NCT04576611: LOw Level of Activity (LOLA): Education and Exercise-based Intervention for Low Back Pain
Official title: Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Mobile Applications
Muscle and Stretching Exercises
Physical Exercise
Behavior
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-10-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cognitive functioning assessment.
timeFrame: Up to 4 weeks.
measure: Heart Rate Variability (HRV)
timeFrame: Up to 4 weeks.
measure: Pressure pain thresholds (PPT).
timeFrame: Up to 12 weeks.
Secondary outcomes:
measure: Balance
timeFrame: Up to 12 weeks.
measure: Range of movement
timeFrame: Up to 12 weeks.
measure: Clinical pain
timeFrame: Up to 12 weeks.
measure: Pain interference
timeFrame: Up to 12 weeks.
measure: Affective symptoms (Mood)
timeFrame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
measure: Affective symptoms (anxiety)
timeFrame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
measure: Cognitive symptoms (catastrophizing)
timeFrame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
measure: Cognitive symptoms (fear-avoidance beliefs)
timeFrame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
measure: Cognitive symptoms (kinesiophobia)
timeFrame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Other outcomes:
Locations:
city: Palma
country: Spain
facility: University of the Balearic Islands
state: Illes Balears
Study officials:
affiliation: University of Balearic Islands, Department of Psychology
name: Carolina Sitges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.