New Technologies in the Management of Lumbopelvic Pain

Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Exercise; Rehabilitation
• Intervention / Treatment: Other: therapeutic exercise

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alcalá De Henares, Spain
    • Centro de Fisioterapia Villatoro-Luque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tele-rehabilitation group; The participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.	Other: therapeutic exercise; As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin. The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group. On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application. On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks. At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.
EXPERIMENTAL: Face to face group; Participants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.	Other: therapeutic exercise; As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin. The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group. On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application. On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks. At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Using the SF-12 Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain perception	Using the Visual Analog Scale (VAS) from 0 to 10	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Disability	Using the Oswestry Disability Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Physical Activity	Using the Baecke Physical Activity Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Kinesiophobia	Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Sleep Quality	Using the Pittsburgh Sleep Quality Index	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Catastrophism	Using the Pain catastrophizing scale from 0 to 56	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Lumbar motor control	Using the Rocking backward test.	Baseline, 2 months (primary timepoint).
Change in Lumbar motor control	Using the knee extended test.	Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles	Using the Double straight-leg raise test.	Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles	Using the Ito test.	Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity hip flexor muscles	Using the Hip flexion test supine position and sitting position	Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity extensor flexor muscles	Using the Hip extension test prone position	Baseline, 2 months (primary timepoint).

Collaborators and Investigators

• Sponsor: Alexander Achalandabaso
• Investigators: Principal Investigator: Francisco Villatoro, University of Jaén

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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;(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2020
• Primary Completion (ACTUAL): April 15, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEID/HU/2020/48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No