A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain

A Study Protocol Randomised Feasibility Trial Comparing a Home Rehabilitation Program Versus e-Health Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Non-specific Low Back Pain

The aim of this randomized controlled trial is to evaluate the feasibility and effectiveness of providing an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the McKenzie Method for patients with chronic low back pain in primary care, compared with the same home rehabilitation program but without the support of an electronic program.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Home Rehabilitation Program; Other: e-Health program

Detailed 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 effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 04001
    • Almeria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Low back pain ≥ 3 months.
• Age between 30 and 67 years old.
• Score ≥ 4 points on the Roland Morris Disability Questionnaire.
• 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.
• Agoraphobia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home rehabilitation program; It consists in a home rehabilitation program. Patients will recieve electroanalgesia with TENS and an exercise program following the McKenzie method. At first and second sessions, patients will be instructed on how to use electroanalgesia and how to perform the exercises. Then, patients will perform the therapy at home. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions	Other: Home Rehabilitation Program; It consists in a home rehabilitation program 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.
Active Comparator: e-Health program; It consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions	Other: e-Health 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline the acceptability and demand of the e-Health intervention for patients and physiotherapists in comparison with the home rehabilitation program for the optimization of their design, development and delivery	The extent to which participants who have received the intervention through a web application consider that the content and support materials (web application and initial learning sessions) are appropriate and satisfactory to obtain the expected results.The extent to which the physiotherapists who have administered the intervention consider that the training, content and support materials are appropriate.Brief questionnaire developed for this trial* 10-items Patients rate their acceptability and demand of treatment received and trial participation, including the burden of outcome measure completion. Measured with 10-point numeric rating scales ranging from not at all satisfactory to extremely satisfactory	At baseline, immediate post-treatment and 6 months
Change from baseline the feasibility of the trial procedures	The extent to which participants believe that their eligibility, outcome measures, follow-up and intervention by the physiotherapist have been satisfactory. The extent to which physiotherapists who have participated in the trial consider recruitment, outcome measures, evaluation follow-ups and appropriate and satisfactory intervention procedures.Brief questionnaire developed for this trial* 4-items Measured with 10-point numeric rating scales ranging from not at all helpful to extremely helpful	At baseline, immediate post-treatment and 6 months
Change from baseline adaptation of the e-Health intervention and the trial procedures for to randomized clinical trial definitive	The extent to which the content of the e-health intervention, support materials and learning classes should be modified to improve their acceptability and implementation for a future definitive trial The extent to which recruitment, follow-up procedures and the number and outcome measures should be modified during / at the end of the trial to improve its acceptability and implementation for a definitive future trial.Brief questionnaire developed for this trial* 11-items Measured using yes/no responses	At baseline, immediate post-treatment and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Roland Morris Disability Questionnaire	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
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
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
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
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.The higher the score, the higher the quality of life	At baseline, at 8 weeks and at 6 months
Change from Mcquade Test.	It measures the isometric endurance of trunk flexion muscles in seconds.	At baseline, at 8 weeks and at 6 months
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
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
Change from baselina in range of motion and 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

Collaborators and Investigators

• Sponsor: Universidad de Almeria
• Investigators: Principal Investigator: Adelaida María Castro-Sánchez, PhD, Almeria University

Publications and helpful links

General Publications

• Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
• Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
• 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.
• 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.
• 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.
• Elfering A, Semmer N, Birkhofer D, Zanetti M, Hodler J, Boos N. Risk factors for lumbar disc degeneration: a 5-year prospective MRI study in asymptomatic individuals. Spine (Phila Pa 1976). 2002 Jan 15;27(2):125-34. doi: 10.1097/00007632-200201150-00002.
• Haladay DE, Miller SJ, Challis J, Denegar CR. Quality of systematic reviews on specific spinal stabilization exercise for chronic low back pain. J Orthop Sports Phys Ther. 2013 Apr;43(4):242-50. doi: 10.2519/jospt.2013.4346. Epub 2013 Jan 14.
• 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.
• Descarreaux M, Normand MC, Laurencelle L, Dugas C. Evaluation of a specific home exercise program for low back pain. J Manipulative Physiol Ther. 2002 Oct;25(8):497-503. doi: 10.1067/mmt.2002.127078.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; Randomized Controlled Trial; e-health; exercise program; electroanalgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PC-0185-2017

Drug and device information, study documents

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