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

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT03469024
• Lead Sponsor: Universidad de Almeria

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.

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 Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-05-01
• Primary Completion: 2020-10-15
• Study Completion: 2021-04-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).	At baseline, at 8 weeks and at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity. Visual analogue scale.	At baseline, at 8 weeks and at 6 months	A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Change from baseline in lumbar mobility flexion.	At baseline, at 8 weeks and at 6 months	For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.	At baseline, at 8 weeks and at 6 months.	It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	At baseline, at 8 weeks and at 6 months	Is a 17-item questionnaire that measures the fear of movement and (re)injury.
Change from Mcquade Test.	At baseline, at 8 weeks and at 6 months	It measures the isometric endurance of trunk flexion muscles.
Change from baseline on Quality of Life. SF-36 Health questionnaire.	At baseline, at 8 weeks and at 6 months	. SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Changes from baseline in Lumbar electromyography.	At baseline, at 8 weeks and at 6 months	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.
Change from baselina in range of motion and lumbar segmental mobility	At baseline, at 8 weeks and at 6 months	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.

Trial Locations

Locations (1)

University of Almería; 🇪🇸 Almería, Andalucía, Spain