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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home Rehabilitation Program
e-Health program
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Electroanalgesia, Exercise program, 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.
  • 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

  • University of Almería

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 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.

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.
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
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.
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 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

First Posted
March 12, 2018
Last Updated
September 20, 2023
Sponsor
Universidad de Almeria
Collaborators
Funding: Junta de Andalucía
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1. Study Identification

Unique Protocol Identification Number
NCT03469024
Brief Title
Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain
Official Title
Comparison of Effectiveness of a Home Rehabilitation Program vs an e-Healt 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
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
April 15, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

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, Exercise program, Randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home rehabilitation program
Arm Type
Experimental
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
Arm Title
e-Health program
Arm Type
Active Comparator
Arm Description
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
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
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Description
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.
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.
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
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.
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
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.
Time Frame
At baseline, at 8 weeks and at 6 months
Title
Change from baselina in range of motion and lumbar segmental mobility
Description
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.
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
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida María Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Almería
City
Almería
State/Province
Andalucía
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
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11346328
Citation
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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.
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Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain

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