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Positional Device Aimed at Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

25 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with low back pain

Exclusion Criteria:

  • patients with a history of vertebral surgery
  • patients with spinal tumors
  • patients with intervertebral disc infections
  • patients with vertebral fractures
  • patients with severe osteoporosis
  • patients with ankylosing processes of the spine
  • patients with heart diseases

Sites / Locations

  • Universidade do Estado do Pará

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pelvic suspension device

Arm Description

A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material.

Outcomes

Primary Outcome Measures

Lumbar dynamometry
The dynamometer is an instrument used to assess muscle strength in individuals with normal health status and/or in the process of rehabilitation (EICHINGER et al., 2015). The lumbar dynamometer has the function of measuring the isometric strength of the extensor musculature of the Lumbar spine. The participant is positioned standing on the platform of the equipment with total extension of knees, trunk in flexion with about 120º and the head accompanies the extension of the trunk, the hands hold the dynamometer bar positioned previously. For learning, the participant performs two to three subm maxima contractions. Then, the maximum contraction is requested in 3 attempts with one minute of rest
Photogrammetric goniometry
Active mobility of the lumbar spine will be evaluated by means of photogrammetry with the same instruments of postural assessment. The flexion, extension, and lateral flexion movements on the right and left will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
April 27, 2021
Sponsor
Universidade Metodista de Piracicaba
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1. Study Identification

Unique Protocol Identification Number
NCT04513730
Brief Title
Positional Device Aimed at Patients With Low Back Pain
Official Title
Development of a Positional Device Aimed at Patients With Reduced Mobility and Functional Capacity Due to Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The project aims to idealize a pelvic suspension device as an auxiliary physiotherapeutic resource for patients with reduced mobility and functional capacity, which should favor autonomous and independent performance in personal, social and work tasks of the target population. This is a controlled clinical trial study. The research sample will be composed of patients of both sexes, aged 21 to 65 years, diagnosed with low back pain, referred to UEAFTO/UEPA, through the SUS care network. The research participants will be evaluated by posture, active mobility and muscle strength of the spine, evaluation of pain intensity and functional capacity. A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material. Participants will be submitted to 10 sessions of use of the device, after which they will be reevaluated through the same procedures. The information collected will be analyzed through the Graphpad prism software. To compare measured values, the Shapiro-Wilk test will be used for normality distribution. Student's t-tests will be used for the treatment of variables with normal distribution, and Fisher's and Mann-Whitney's exact tests for variables without normal distribution. It is expected to collaborate in the social integration, labor and quality of life of people affected by low back pain, as well as to promote the development of low-cost technologies in the routine of Physiotherapy and public health in the State of Pará.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A device originally designed with the function of keeping the user in a comfortable position of pelvic suspension, in dorsal decubitus, with fixation in the popliteal region and ankles was built to promote lumbar traction. The device is designed in auto CAD software with 2d technical representations and 3d electronic model. It consists of a structure of PVC pipes and fittings and padded material at the support points. The structure design was based on anthropometric models according to Felisberto and Paschoarelli (2000). Participants belonging to both groups will receive information about the procedures performed including the objectives, risks and benefits and study protocol Participants belonging to the intervention group will be submitted to 10 pelvic suspension technique sessions using the functional prototype of the device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pelvic suspension device
Arm Type
Experimental
Arm Description
A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
A device originally designed with the function of keeping the user in a comfortable position of pelvic suspension, in dorsal decubitus, with fixation in the popliteal region and ankles was built to promote lumbar traction. The device is designed in autoCAD software with 2d technical representations and 3d electronic model. It consists of a structure of pipes and fittings and padded material at the support points.
Primary Outcome Measure Information:
Title
Lumbar dynamometry
Description
The dynamometer is an instrument used to assess muscle strength in individuals with normal health status and/or in the process of rehabilitation (EICHINGER et al., 2015). The lumbar dynamometer has the function of measuring the isometric strength of the extensor musculature of the Lumbar spine. The participant is positioned standing on the platform of the equipment with total extension of knees, trunk in flexion with about 120º and the head accompanies the extension of the trunk, the hands hold the dynamometer bar positioned previously. For learning, the participant performs two to three subm maxima contractions. Then, the maximum contraction is requested in 3 attempts with one minute of rest
Time Frame
post treatment in 3 days
Title
Photogrammetric goniometry
Description
Active mobility of the lumbar spine will be evaluated by means of photogrammetry with the same instruments of postural assessment. The flexion, extension, and lateral flexion movements on the right and left will be evaluated.
Time Frame
post treatment in 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with low back pain Exclusion Criteria: patients with a history of vertebral surgery patients with spinal tumors patients with intervertebral disc infections patients with vertebral fractures patients with severe osteoporosis patients with ankylosing processes of the spine patients with heart diseases
Facility Information:
Facility Name
Universidade do Estado do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66055-490
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32517498
Citation
Mataran-Penarrocha GA, Lara Palomo IC, Antequera Soler E, Gil-Martinez E, Fernandez-Sanchez M, Aguilar-Ferrandiz ME, Castro-Sanchez AM. Comparison of efficacy of a supervised versus non-supervised physical therapy exercise program on the pain, functionality and quality of life of patients with non-specific chronic low-back pain: a randomized controlled trial. Clin Rehabil. 2020 Jul;34(7):948-959. doi: 10.1177/0269215520927076. Epub 2020 Jun 10.
Results Reference
result
PubMed Identifier
31780447
Citation
Hayden JA, Wilson MN, Stewart S, Cartwright JL, Smith AO, Riley RD, van Tulder M, Bendix T, Cecchi F, Costa LOP, Dufour N, Ferreira ML, Foster NE, Gudavalli MR, Hartvigsen J, Helmhout P, Kool J, Koumantakis GA, Kovacs FM, Kuukkanen T, Long A, Macedo LG, Machado LAC, Maher CG, Mehling W, Morone G, Peterson T, Rasmussen-Barr E, Ryan CG, Sjogren T, Smeets R, Staal JB, Unsgaard-Tondel M, Wajswelner H, Yeung EW; Chronic Low Back Pain IPD Meta-Analysis Group. Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials. Br J Sports Med. 2020 Nov;54(21):1277-1278. doi: 10.1136/bjsports-2019-101205. Epub 2019 Nov 28.
Results Reference
result
PubMed Identifier
31547140
Citation
Calatayud J, Escriche-Escuder A, Cruz-Montecinos C, Andersen LL, Perez-Alenda S, Aiguade R, Casana J. Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. Int J Environ Res Public Health. 2019 Sep 20;16(19):3509. doi: 10.3390/ijerph16193509.
Results Reference
result
PubMed Identifier
31133917
Citation
Suso-Ribera C, Camacho-Guerrero L, Osma J, Suso-Vergara S, Gallardo-Pujol D. A Reduction in Pain Intensity Is More Strongly Associated With Improved Physical Functioning in Frustration Tolerant Individuals: A Longitudinal Moderation Study in Chronic Pain Patients. Front Psychol. 2019 Apr 26;10:907. doi: 10.3389/fpsyg.2019.00907. eCollection 2019.
Results Reference
result
PubMed Identifier
30784788
Citation
Arguisuelas MD, Lison JF, Domenech-Fernandez J, Martinez-Hurtado I, Salvador Coloma P, Sanchez-Zuriaga D. Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized controlled trial. Clin Biomech (Bristol, Avon). 2019 Mar;63:27-33. doi: 10.1016/j.clinbiomech.2019.02.009. Epub 2019 Feb 14.
Results Reference
result

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Positional Device Aimed at Patients With Low Back Pain

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