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New Technologies in the Management of Lumbopelvic Pain

Primary Purpose

Low Back Pain, Rehabilitation, Exercise

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
therapeutic exercise
Sponsored by
Alexander Achalandabaso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-65 years.
  • Non-specific low back pain less than 12 weeks of evolution.
  • Knowledge of new information and communication technologies.
  • Internet access.

Exclusion Criteria:

  • Inflammatory pathologies of the locomotor system.
  • Infectious processes.
  • Oncological processes.
  • Neurodegenerative diseases.
  • Pain with neuropathic characteristics.
  • Fractures.
  • Lack of fluency in Spanish.

Sites / Locations

  • Centro de Fisioterapia Villatoro-Luque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tele-rehabilitation group

Face to face group

Arm Description

The participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.

Participants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.

Outcomes

Primary Outcome Measures

Change in Quality of Life
Using the SF-12 Questionnaire

Secondary Outcome Measures

Change in Pain perception
Using the Visual Analog Scale (VAS) from 0 to 10
Change in Disability
Using the Oswestry Disability Questionnaire
Change in Physical Activity
Using the Baecke Physical Activity Questionnaire
Change in Kinesiophobia
Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44
Change in Sleep Quality
Using the Pittsburgh Sleep Quality Index
Change in Catastrophism
Using the Pain catastrophizing scale from 0 to 56
Change in Lumbar motor control
Using the Rocking backward test.
Change in Lumbar motor control
Using the knee extended test.
Change in Intramuscular contraction capacity erector muscles
Using the Double straight-leg raise test.
Change in Intramuscular contraction capacity erector muscles
Using the Ito test.
Change in Intramuscular contraction capacity hip flexor muscles
Using the Hip flexion test supine position and sitting position
Change in Intramuscular contraction capacity extensor flexor muscles
Using the Hip extension test prone position

Full Information

First Posted
December 17, 2020
Last Updated
July 20, 2021
Sponsor
Alexander Achalandabaso
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1. Study Identification

Unique Protocol Identification Number
NCT04685837
Brief Title
New Technologies in the Management of Lumbopelvic Pain
Official Title
Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexander Achalandabaso

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
Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem. Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Rehabilitation, Exercise

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tele-rehabilitation group
Arm Type
Experimental
Arm Description
The participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.
Arm Title
Face to face group
Arm Type
Experimental
Arm Description
Participants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator.
Intervention Type
Other
Intervention Name(s)
therapeutic exercise
Intervention Description
As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin. The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group. On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application. On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks. At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.
Primary Outcome Measure Information:
Title
Change in Quality of Life
Description
Using the SF-12 Questionnaire
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary Outcome Measure Information:
Title
Change in Pain perception
Description
Using the Visual Analog Scale (VAS) from 0 to 10
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Disability
Description
Using the Oswestry Disability Questionnaire
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Physical Activity
Description
Using the Baecke Physical Activity Questionnaire
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Kinesiophobia
Description
Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Sleep Quality
Description
Using the Pittsburgh Sleep Quality Index
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Catastrophism
Description
Using the Pain catastrophizing scale from 0 to 56
Time Frame
Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Title
Change in Lumbar motor control
Description
Using the Rocking backward test.
Time Frame
Baseline, 2 months (primary timepoint).
Title
Change in Lumbar motor control
Description
Using the knee extended test.
Time Frame
Baseline, 2 months (primary timepoint).
Title
Change in Intramuscular contraction capacity erector muscles
Description
Using the Double straight-leg raise test.
Time Frame
Baseline, 2 months (primary timepoint).
Title
Change in Intramuscular contraction capacity erector muscles
Description
Using the Ito test.
Time Frame
Baseline, 2 months (primary timepoint).
Title
Change in Intramuscular contraction capacity hip flexor muscles
Description
Using the Hip flexion test supine position and sitting position
Time Frame
Baseline, 2 months (primary timepoint).
Title
Change in Intramuscular contraction capacity extensor flexor muscles
Description
Using the Hip extension test prone position
Time Frame
Baseline, 2 months (primary timepoint).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-65 years. Non-specific low back pain less than 12 weeks of evolution. Knowledge of new information and communication technologies. Internet access. Exclusion Criteria: Inflammatory pathologies of the locomotor system. Infectious processes. Oncological processes. Neurodegenerative diseases. Pain with neuropathic characteristics. Fractures. Lack of fluency in Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Villatoro
Organizational Affiliation
University of Jaén
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Fisioterapia Villatoro-Luque
City
Alcalá De Henares
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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15949782
Citation
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New Technologies in the Management of Lumbopelvic Pain

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