Positional Device Aimed at Patients With Low Back Pain

NCT04513730 | Completed DMC

• 1 other identifier: F110821
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

pelvic suspension device

EXPERIMENTAL

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.

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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.

pelvic suspension device

Eligibility Criteria

• Age: 25 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with low back pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead

Study Sites (1)

Universidade do Estado do Pará

Belém, Pará, 66055-490, Brazil

Location

Related Publications (5)

• 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.

  PMID: 32517498 RESULT

• 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.

  PMID: 31780447 RESULT

• 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.

  PMID: 31547140 RESULT

• 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.

  PMID: 31133917 RESULT

• 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). 2019 Mar;63:27-33. doi: 10.1016/j.clinbiomech.2019.02.009. Epub 2019 Feb 14.

  PMID: 30784788 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Human Movement Department

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: August 11, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

BR (1)