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Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Face-to-Face Rehabilitation program

Telemedicine program

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Electroanalgesia, McKenzie Method, Telemedicine, Study protocol for a Randomized clinical 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.
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.

Sites / Locations

Universidad de Almería

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Face-to Face rehabilitation program

Telemedicine Program

Arm Description

Electroanalgesia therapy and the McKenzie exercise protocol will be applied by six therapists with more than 10 years of experience. This program will be developed in the rehabilitation service of the study health centers. 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 8 weeks, with a total of 24 sessions

Outcomes

Primary Outcome Measures

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.Ranging from 0 points- better to 24 points- worse disability

Secondary Outcome Measures

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.

Change from Mcquade Test

It measures the isometric endurance of trunk flexion muscles.

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

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.

Change from baselina in lumbar segmental mobility

Change from baseline in indirect non-medical costs

sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level.

Change from baseline in direct medical costs

costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products

Change from baseline direct non-medical costs

The patient expenses in transportation

Full Information

NCT ID

NCT04266366

First Posted

February 7, 2020

Last Updated

November 29, 2022

Sponsor

Universidad de Almeria

Collaborators

Funding: Junta de Andalucía

1. Study Identification

Unique Protocol Identification Number

NCT04266366

Brief Title

Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

Official Title

Comparison of Cost and Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Almeria

Collaborators

Funding: Junta de Andalucía

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Perform a cost-utility analysis in patients with chronic low back pain through electroanalgesia treatment and exercises administered by telemedicine program versus face-to-face 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 cost- effectiveness of a face-to- face rehabilitation program vs a telemedicine 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

Low Back Pain

Keywords

Low back pain, Electroanalgesia, McKenzie Method, Telemedicine, Study protocol for a Randomized clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Study protocol for a double blinded two-arm randomized controlled trial

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Face-to Face rehabilitation program

Arm Type

Active Comparator

Arm Description

Arm Title

Telemedicine Program

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Face-to-Face Rehabilitation program

Intervention Description

In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.

Intervention Type

Other

Intervention Name(s)

Telemedicine 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

Change from baseline in Roland Morris Disability Questionnaire (RMDQ).

Description

Time Frame

At baseline, at 8 weeks and at 6 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

At baseline, at 8 weeks and at 6 months.

Title

Change from baseline in pain intensity. Visual analogue scale.

Description

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

Time Frame

At baseline, at 8 weeks and at 6 months

Title

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

Description

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.

Time Frame

At baseline, at 8 weeks and at 6 months

Title

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

Description

SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from Mcquade Test

Description

It measures the isometric endurance of trunk flexion muscles.

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baseline in lumbar mobility flexion.

Description

For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Changes from baseline in Lumbar electromyography.

Description

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baselina in range of motion

Description

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baselina in lumbar segmental mobility

Description

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baseline in indirect non-medical costs

Description

sick leave days due to low back pain and labor absenteeism costs in terms of workdays lost due to illness at salary level.

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baseline in direct medical costs

Description

costs of visits to primary care, emergency visits, home help received as a result of disability related to LBP, diagnostic tests and pharmaceutical products

Time Frame

At baseline, at 8 weeks and at 6 months

Title

Change from baseline direct non-medical costs

Description

The patient expenses in transportation

Time Frame

At baseline, at 8 weeks and at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

67 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Low back pain ≥ 3 months. Age between 30 and 67 years old. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adelaida María Castro-Sánchez, PhD

Organizational Affiliation

Almería University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad de Almería

City

Almería

State/Province

Andalucía

ZIP/Postal Code

04120

Country

Spain

12. IPD Sharing Statement

Citations:

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11346328

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Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain

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