Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Comparison of Cost and Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266366
• Other study ID #: CE-IP00562
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perform a cost-utility analysis in patients with chronic low back pain through electroanalgesia treatment and exercises administered by telemedicine program versus face-to-face program

Description:

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the cost- effectiveness of a face-to- face rehabilitation program vs a telemedicine program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: October 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 67 Years

Eligibility

Inclusion Criteria:

• Low back pain = 3 months.

• Age between 30 and 67 years old.

• Not being receiving physical therapy.

Exclusion Criteria:

• Presence of lumbar stenosis.

• Diagnosis of spondylolisthesis.

• Diagnosis of fibromyalgia.

• Treatment with corticosteroids or oral medication in recent weeks.

• History of spine surgery.

• Contraindication of analgesic electrical therapy.

• Have previously received a treatment of electrical analgesia or exercise.

• Central or peripheral nervous system disease.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Face-to-Face Rehabilitation program
In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.
• Telemedicine program
It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.

Locations

Country	Name	City	State
Spain	Universidad de Almería	Almería	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Almeria	Funding: Junta de Andalucía

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available. — View Citation

Becker A, Held H, Redaelli M, Strauch K, Chenot JF, Leonhardt C, Keller S, Baum E, Pfingsten M, Hildebrandt J, Basler HD, Kochen MM, Donner-Banzhoff N. Low back pain in primary care: costs of care and prediction of future health care utilization. Spine (Phila Pa 1976). 2010 Aug 15;35(18):1714-20. doi: 10.1097/brs.0b013e3181cd656f. — View Citation

Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005. — View Citation

Froud R, Patterson S, Eldridge S, Seale C, Pincus T, Rajendran D, Fossum C, Underwood M. A systematic review and meta-synthesis of the impact of low back pain on people's lives. BMC Musculoskelet Disord. 2014 Feb 21;15:50. doi: 10.1186/1471-2474-15-50. — View Citation

GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Jensen CE, Riis A, Petersen KD, Jensen MB, Pedersen KM. Economic evaluation of an implementation strategy for the management of low back pain in general practice. Pain. 2017 May;158(5):891-899. doi: 10.1097/j.pain.0000000000000851. — View Citation

Khadilkar A, Milne S, Brosseau L, Robinson V, Saginur M, Shea B, Tugwell P, Wells G. Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003008. doi: 10.1002/14651858.CD003008.pub2. — View 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. — View Citation

Petersen T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with subacute or chronic low back pain: A randomized controlled trial. Spine (Phila Pa 1976). 2002 Aug 15;27(16):1702-9. doi: 10.1097/00007632-200208150-00004. — View Citation

Schaafsma FG, Whelan K, van der Beek AJ, van der Es-Lambeek LC, Ojajarvi A, Verbeek JH. Physical conditioning as part of a return to work strategy to reduce sickness absence for workers with back pain. Cochrane Database Syst Rev. 2013 Aug 30;2013(8):CD001822. doi: 10.1002/14651858.CD001822.pub3. — View Citation

Von Korff M, Moore JC. Stepped care for back pain: activating approaches for primary care. Ann Intern Med. 2001 May 1;134(9 Pt 2):911-7. doi: 10.7326/0003-4819-134-9_part_2-200105011-00016. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Roland Morris Disability Questionnaire (RMDQ).	This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline in disability. Oswestry Low Back Pain Disability Idex.	It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome.	At baseline, at 8 weeks and at 6 months.
Secondary	Change from baseline in pain intensity. Visual analogue scale.	A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their kinesiophobia on a 4-point scale ranging from strongly disagree to strongly agree.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline on Quality of Life. SF-36 Health questionnaire.	SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.	At baseline, at 8 weeks and at 6 months
Secondary	Change from Mcquade Test	It measures the isometric endurance of trunk flexion muscles.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline in lumbar mobility flexion.	For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).	At baseline, at 8 weeks and at 6 months
Secondary	Changes from baseline in Lumbar electromyography.	The degree of electromyographic activation of the lumbar paravertebral musculature will be carried out by using a set of electrodes of 3x7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baselina in range of motion	This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baselina in lumbar segmental mobility	This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline in indirect non-medical costs	sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level.	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline in direct medical costs	costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products	At baseline, at 8 weeks and at 6 months
Secondary	Change from baseline direct non-medical costs	The patient expenses in transportation	At baseline, at 8 weeks and at 6 months