Clinical trial NCT04685837: New Technologies in the Management of Lumbopelvic Pain
Official title: Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Rehabilitation
Exercise
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem.

Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years.
* Non-specific low back pain less than 12 weeks of evolution.
* Knowledge of new information and communication technologies.
* Internet access.

Exclusion Criteria:

* Inflammatory pathologies of the locomotor system.
* Infectious processes.
* Oncological processes.
* Neurodegenerative diseases.
* Pain with neuropathic characteristics.
* Fractures.
* Lack of fluency in Spanish.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary outcomes:
measure: Change in Pain perception
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Disability
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Physical Activity
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Kinesiophobia
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Sleep Quality
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Catastrophism
timeFrame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
measure: Change in Lumbar motor control
timeFrame: Baseline, 2 months (primary timepoint).
measure: Change in Lumbar motor control
timeFrame: Baseline, 2 months (primary timepoint).
measure: Change in Intramuscular contraction capacity erector muscles
timeFrame: Baseline, 2 months (primary timepoint).
measure: Change in Intramuscular contraction capacity erector muscles
timeFrame: Baseline, 2 months (primary timepoint).
measure: Change in Intramuscular contraction capacity hip flexor muscles
timeFrame: Baseline, 2 months (primary timepoint).
measure: Change in Intramuscular contraction capacity extensor flexor muscles
timeFrame: Baseline, 2 months (primary timepoint).
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro de Fisioterapia Villatoro-Luque
Study officials:
affiliation: University of Jaén
name: Francisco Villatoro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waddell G, Burton AK. Concepts of rehabilitation for the management of low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):655-70. doi: 10.1016/j.berh.2005.03.008.
citation: Macedo LG, Maher CG, Hancock MJ, Kamper SJ, McAuley JH, Stanton TR, Stafford R, Hodges PW. Predicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial. Phys Ther. 2014 Nov;94(11):1543-54. doi: 10.2522/ptj.20140014. Epub 2014 Jul 10.
citation: Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
citation: Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.
citation: Dario AB, Moreti Cabral A, Almeida L, Ferreira ML, Refshauge K, Simic M, Pappas E, Ferreira PH. Effectiveness of telehealth-based interventions in the management of non-specific low back pain: a systematic review with meta-analysis. Spine J. 2017 Sep;17(9):1342-1351. doi: 10.1016/j.spinee.2017.04.008. Epub 2017 Apr 13.
citation: Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.
citation: Mbada CE, Olaoye MI, Dada OO, Ayanniyi O, Johnson OE, Odole AC, Ishaya GP, Omole OJ, Makinde MO. Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. Int J Telerehabil. 2019 Jun 12;11(1):41-58. doi: 10.5195/ijt.2019.6260. eCollection 2019 Spring.
citation: del Pozo-Cruz B, Gusi N, del Pozo-Cruz J, Adsuar JC, Hernandez-Mocholi M, Parraca JA. Clinical effects of a nine-month web-based intervention in subacute non-specific low back pain patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):28-39. doi: 10.1177/0269215512444632. Epub 2012 May 31.
citation: Peterson S, Kuntz C, Roush J. Use of a modified treatment-based classification system for subgrouping patients with low back pain: Agreement between telerehabilitation and face-to-face assessments. Physiother Theory Pract. 2019 Nov;35(11):1078-1086. doi: 10.1080/09593985.2018.1470210. Epub 2018 May 3.
citation: Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.
citation: Cuesta Vargas AI, Rodríguez Moya A. Frecuencia de uso de escalas de dolor, incapacidad fisica y calidad de vida en el estudio de lumbalgia con intervenciones fisioterápicas. Fisioterapia 2008; 30(4), 204-208.
citation: Flórez García MT, García Pérez MA, García Pérez F, et al. Adaptación transcultural a la población española de la escala de incapacidad por dolor lumbar de Oswestry. Rehab (Madr). 1995; 29:138-45.
citation: Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.
citation: Hita-Contreras F, Martinez-Lopez E, Latorre-Roman PA, Garrido F, Santos MA, Martinez-Amat A. Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014 Jul;34(7):929-36. doi: 10.1007/s00296-014-2960-z. Epub 2014 Feb 8.