Effectiveness of Therapeutic Exercise App Adding a Face-to-face Physical Therapist in Low Back Pain

NCT04975568 | Completed

• 1 other identifier: CI 19/514-E
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms slightly improve. The value of personalized therapeutic exercised programs in patients suffering LBP has been shown nowadays, improving symptomatology and quality of life. New technologies help patients to engage more in treatment, while time that health education make people "active patients". The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days with a physical therapist .

Conditions

Low Back Pain

Keywords

Physiotherapy; Mobile Applications; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale

  Intensity of low back pain (measured by Pain Intensity- Numerical Rating Scale ( PI-NRS)) at rest. It will be valued three times with 1 min between the three valuations. 1 item, minimum value 0 and maximum value 10, and 10 is the worse value and the average will be recorded.

  12 weeks treatment

Secondary Outcomes (3)

• Number of participants with improve degree of Low Back pain disability based in Oswestry test

  At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment

• Number of participants with improve degree of quality of life based in Spanish version of the Short Form Health Survey

  At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment

• Level of physical therapy intervention satisfaction based in Spanish version of the Patient Satisfaction Questionnaire

  12 weeks treatment

Study Arms (2)

Therapeutic Exercise Controlled Through App With face-to-face

EXPERIMENTAL

3 months treatment using app for HTEP and 6 people therapeutic exercise group every 15 days

Other: App and face-to-face physical therapy; Other: App physical therapy

Therapeutic Exercise Controlled Through App

ACTIVE COMPARATOR

3 months treatment using app for HTEP

Other: App physical therapy

Interventions

App and face-to-face physical therapy OTHER

Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. During the app used they will have 6 face-to-face sessions in 6 people groups with a physical Therapist in a 3 months period

Therapeutic Exercise Controlled Through App With face-to-face

App physical therapy OTHER

Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites.

Therapeutic Exercise Controlled Through App; Therapeutic Exercise Controlled Through App With face-to-face

Eligibility Criteria

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

You may qualify if:

• ≥ 18 and ≤ 65 years old.
• Suffering low back pain.
• In a subacute and chronic phase

You may not qualify if:

• Non signature of the informed consent
• Red Flags are risk factors detected in low back pain patients' past medical history and symptomatology and are associated with a higher risk of serious disorders causing low back pain compared to patients without these characteristics.
• Yellow Flags are psychosocial factors that increase the risk of developing, or perpetuating chronic pain and long-term disability (including) work-loss associated with low back pain.
• Pregnancy and lactation
• Serious trauma or back surgery before the study
• Illness or dysfunction of balance
• Visual dysfunction.
• Neurological illness, dysfunction or pain.
• Inability to stand up and sit without help
• Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal instructions (e.g. Illiteracy, dementia or blindness) or read, understand and use an app

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS: collaborator

Study Sites (1)

Jose Javier López Marcos

Madrid, 28917, Spain

Location

Related Publications (21)

• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014 Jun;15(6):569-85. doi: 10.1016/j.jpain.2014.03.005. Epub 2014 Apr 29.

  PMID: 24787228 BACKGROUND

• Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.

  PMID: 11172169 BACKGROUND

• Mesas AE, Gonzalez AD, Mesas CE, de Andrade SM, Magro IS, del Llano J. The association of chronic neck pain, low back pain, and migraine with absenteeism due to health problems in Spanish workers. Spine (Phila Pa 1976). 2014 Jul 1;39(15):1243-53. doi: 10.1097/BRS.0000000000000387.

  PMID: 24825151 BACKGROUND

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 BACKGROUND

• Lotzke H, Jakobsson M, Gutke A, Hagstromer M, Brisby H, Hagg O, Smeets R, Lundberg M. Patients with severe low back pain exhibit a low level of physical activity before lumbar fusion surgery: a cross-sectional study. BMC Musculoskelet Disord. 2018 Oct 11;19(1):365. doi: 10.1186/s12891-018-2274-5.

  PMID: 30305065 BACKGROUND

• da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29.

  PMID: 28355981 BACKGROUND

• Hanney WJ, Masaracchio M, Liu X, Kolber MJ. The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature. PLoS One. 2016 Jun 10;11(6):e0156799. doi: 10.1371/journal.pone.0156799. eCollection 2016.

  PMID: 27285608 BACKGROUND

• Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017 Sep;23(9):733-740. doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6.

  PMID: 28328396 BACKGROUND

• Chao DY, Lin TM, Ma WY. Enhanced Self-Efficacy and Behavioral Changes Among Patients With Diabetes: Cloud-Based Mobile Health Platform and Mobile App Service. JMIR Diabetes. 2019 May 10;4(2):e11017. doi: 10.2196/11017.

  PMID: 31094324 BACKGROUND

• Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5.

  PMID: 30431384 BACKGROUND

• Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.

  PMID: 31167489 BACKGROUND

• Bedson J, Hill J, White D, Chen Y, Wathall S, Dent S, Cooke K, van der Windt D. Development and validation of a pain monitoring app for patients with musculoskeletal conditions (The Keele pain recorder feasibility study). BMC Med Inform Decis Mak. 2019 Jan 25;19(1):24. doi: 10.1186/s12911-019-0741-z.

  PMID: 30683106 BACKGROUND

• Chhabra HS, Sharma S, Verma S. Smartphone app in self-management of chronic low back pain: a randomized controlled trial. Eur Spine J. 2018 Nov;27(11):2862-2874. doi: 10.1007/s00586-018-5788-5. Epub 2018 Oct 15.

  PMID: 30324496 BACKGROUND

• Machado GC, Pinheiro MB, Lee H, Ahmed OH, Hendrick P, Williams C, Kamper SJ. Smartphone apps for the self-management of low back pain: A systematic review. Best Pract Res Clin Rheumatol. 2016 Dec;30(6):1098-1109. doi: 10.1016/j.berh.2017.04.002. Epub 2017 May 25.

  PMID: 29103552 BACKGROUND

• Durall CJ, Udermann BE, Johansen DR, Gibson B, Reineke DM, Reuteman P. The effects of preseason trunk muscle training on low-back pain occurrence in women collegiate gymnasts. J Strength Cond Res. 2009 Jan;23(1):86-92. doi: 10.1519/JSC.0b013e31818b93ac.

  PMID: 19057402 BACKGROUND

• Hewett TE, Myer GD, Ford KR. Reducing knee and anterior cruciate ligament injuries among female athletes: a systematic review of neuromuscular training interventions. J Knee Surg. 2005 Jan;18(1):82-8. doi: 10.1055/s-0030-1248163.

  PMID: 15742602 BACKGROUND

• McGill SM, Hughson RL, Parks K. Lumbar erector spinae oxygenation during prolonged contractions: implications for prolonged work. Ergonomics. 2000 Apr;43(4):486-93. doi: 10.1080/001401300184369.

  PMID: 10801082 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.

  PMID: 29321111 BACKGROUND

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 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

Related Links

• Chapter 4. European guidelines for the management of chronic nonspecific low back pain. European Spine Journal : Official Publication of the European Spine Society
• Instituto nacional de estadística. Mujeres y Hombres en España.
• Instituto nacional de estadística
• Adaptación y validación de un cuestionario para medir la satisfacción del tratamiento de fisioterapia en atención primaria

MeSH Terms

Conditions

Low Back Pain

Interventions

Amyloid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jose Javier Lopez Marcos, Master

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 23, 2021
• Study Start: April 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 7, 2022

Record last verified: 2021-04

Locations

ES (1)