New Technologies in the Management of Lumbopelvic Pain

NCT04685837 | Completed

• 1 other identifier: CEID/HU/2020/48
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  Using the SF-12 Questionnaire

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

Secondary Outcomes (12)

• Change in Pain perception

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

• Change in Disability

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

• Change in Physical Activity

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

• Change in Kinesiophobia

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

• Change in Sleep Quality

  Baseline, 2 months (primary timepoint), 3 months after intervention commencement.

Study Arms (2)

Tele-rehabilitation group

EXPERIMENTAL

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

Face to face group

EXPERIMENTAL

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

Interventions

therapeutic exercise OTHER

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.

Face to face group; Tele-rehabilitation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexander Achalandabaso: lead

Study Sites (1)

Centro de Fisioterapia Villatoro-Luque

Alcalá de Henares, Spain

Location

Related Publications (14)

• 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.

  PMID: 15949782 BACKGROUND

• 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.

  PMID: 25013000 BACKGROUND

• 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.

  PMID: 16034851 BACKGROUND

• 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.

  PMID: 24283249 BACKGROUND

• 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.

  PMID: 28412562 BACKGROUND

• 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.

  PMID: 23238489 BACKGROUND

• 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.

  PMID: 31341546 BACKGROUND

• 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.

  PMID: 22653374 BACKGROUND

• 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.

  PMID: 29723124 BACKGROUND

• 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.

  PMID: 18570798 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20926355 BACKGROUND

• 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.

  PMID: 24509897 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Francisco Villatoro

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapy doctor

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 28, 2020
• Study Start: December 21, 2020
• Primary Completion: April 15, 2021
• Study Completion: June 15, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)