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

NCT04283370 | Completed

• 1 other identifier: PC-0185-2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

low back pain; electroanalgesia; exercise program; e-health; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change from baseline in Roland Morris Disability Questionnaire

  At baseline, at 8 weeks and at 6 months

• Change from baseline in disability. Oswestry Low Back Pain Disability Idex.

  At baseline, at 8 weeks and at 6 months

• Change from baseline in pain intensity. Visual analogue scale.

  At baseline, at 8 weeks and at 6 months

• Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

  At baseline, at 8 weeks and at 6 months

• Change from baseline on Quality of Life. SF-36 Health questionnaire.

  At baseline, at 8 weeks and at 6 months

Study Arms (2)

Home rehabilitation program

EXPERIMENTAL

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

e-Health program

ACTIVE COMPARATOR

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

Interventions

Home Rehabilitation Program OTHER

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.

Home rehabilitation program

e-Health program OTHER

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.

e-Health program

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Almeria University

Almería, 04001, Spain

Location

Related Publications (10)

• 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.

  PMID: 11346328 BACKGROUND

• 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.

  PMID: 23990391 BACKGROUND

• 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.

  PMID: 21374895 BACKGROUND

• 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.

  PMID: 10872758 BACKGROUND

• 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.

  PMID: 11805656 BACKGROUND

• 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.

  PMID: 23321935 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

• 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.

  PMID: 12381971 BACKGROUND

• 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.

  PMID: 12195058 BACKGROUND

• 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.

  PMID: 18843638 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Adelaida María Castro-Sánchez, PhD

  Almeria University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 25, 2020
• Study Start: September 5, 2020
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ES (1)