Positional Device Aimed at Patients With Low Back Pain

Low Back Pain Clinical Trial

Official title:

Development of a Positional Device Aimed at Patients With Reduced Mobility and Functional Capacity Due to Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513730
• Other study ID #: F110821
• Status: Completed
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Rehabilitation
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.

Locations

Country	Name	City	State
Brazil	Universidade do Estado do Pará	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Arguisuelas MD, Lisón JF, Doménech-Fernández J, Martínez-Hurtado I, Salvador Coloma P, Sánchez-Zuriaga D. Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized co — View Citation

Calatayud J, Escriche-Escuder A, Cruz-Montecinos C, Andersen LL, Pérez-Alenda S, Aiguadé R, Casaña 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). pii: E3509. doi: — View 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, M — View Citation

Matarán-Peñarrocha GA, Lara Palomo IC, Antequera Soler E, Gil-Martínez E, Fernández-Sánchez M, Aguilar-Ferrándiz ME, Castro-Sánchez AM. Comparison of efficacy of a supervised versus non-supervised physical therapy exercise program on the pain, functionali — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	post treatment in 3 days
Primary	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.	post treatment in 3 days