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

Primary Purpose

Chronic Low-back Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Home Rehabilitation Program

e-Health program

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring low back pain, electroanalgesia, exercise program, e-health, Randomized Controlled Trial

Eligibility Criteria

30 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Almeria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home rehabilitation program

e-Health program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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

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

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.

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

Change from Mcquade Test.

It measures the isometric endurance of trunk flexion muscles in seconds.

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).

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.

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.

Full Information

NCT ID

NCT04283370

First Posted

February 10, 2020

Last Updated

September 20, 2023

Sponsor

Universidad de Almeria

1. Study Identification

Unique Protocol Identification Number

NCT04283370

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 5, 2020 (Actual)

Primary Completion Date

April 30, 2021 (Actual)

Study Completion Date

October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low-back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home rehabilitation program

Arm Type

Experimental

Arm Description

Arm Title

e-Health program

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Home Rehabilitation Program

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

e-Health program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Time Frame

At baseline, immediate post-treatment and 6 months

Title

Change from baseline the feasibility of the trial procedures

Description

Time Frame

At baseline, immediate post-treatment and 6 months

Title

Change from baseline adaptation of the e-Health intervention and the trial procedures for to randomized clinical trial definitive

Description

Time Frame

At baseline, immediate post-treatment and 6 months

Secondary Outcome Measure Information:

Title

Change from baseline in Roland Morris Disability Questionnaire

Description

Time Frame