New Technologies in the Management of Lumbopelvic Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685837
• Other study ID #: CEID/HU/2020/48
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Exercise
• Low Back Pain
• Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro de Fisioterapia Villatoro-Luque	Alcalá De Henares

Sponsors (1)

Lead Sponsor	Collaborator
Alexander Achalandabaso

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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.

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. Review. — View Citation

del Pozo-Cruz B, Gusi N, del Pozo-Cruz J, Adsuar JC, Hernandez-Mocholí 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. — View 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.

Gómez-Pérez L, López-Martínez AE, Ruiz-Párraga 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. — View 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;(3):CD000335. Review. — View Citation

Hita-Contreras F, Martínez-López E, Latorre-Román PA, Garrido F, Santos MA, Martínez-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. — View 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. — View 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. — View Citation

Palacín-Marín 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. — View 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. — View 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. — View Citation

Vilagut G, Valderas JM, Ferrer M, Garin O, López-García 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. Spanish. — View 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	Using the SF-12 Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Pain perception	Using the Visual Analog Scale (VAS) from 0 to 10	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Disability	Using the Oswestry Disability Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Physical Activity	Using the Baecke Physical Activity Questionnaire	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Kinesiophobia	Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Sleep Quality	Using the Pittsburgh Sleep Quality Index	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Catastrophism	Using the Pain catastrophizing scale from 0 to 56	Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary	Change in Lumbar motor control	Using the Rocking backward test.	Baseline, 2 months (primary timepoint).
Secondary	Change in Lumbar motor control	Using the knee extended test.	Baseline, 2 months (primary timepoint).
Secondary	Change in Intramuscular contraction capacity erector muscles	Using the Double straight-leg raise test.	Baseline, 2 months (primary timepoint).
Secondary	Change in Intramuscular contraction capacity erector muscles	Using the Ito test.	Baseline, 2 months (primary timepoint).
Secondary	Change in Intramuscular contraction capacity hip flexor muscles	Using the Hip flexion test supine position and sitting position	Baseline, 2 months (primary timepoint).
Secondary	Change in Intramuscular contraction capacity extensor flexor muscles	Using the Hip extension test prone position	Baseline, 2 months (primary timepoint).