Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain

NCT03469024 | Completed

• 1 other identifier: CFS/apg
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The main objetive of this study is to analyze the effectiveness of a home rehabilitaton program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise of patients with chronic low back pain.

Conditions

Low Back Pain

Keywords

Low back pain; Electroanalgesia; Exercise program; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline, at 8 weeks and at 6 months

Secondary Outcomes (8)

• 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

• Change from Mcquade Test.

  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
• Junta de Andalucia: collaborator

Study Sites (1)

University of Almería

Almería, Andalusia, 04120, 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

  Universidad de Almeria

  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: PhD

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: May 1, 2018
• Primary Completion: October 15, 2020
• Study Completion: April 15, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ES (1)