Assessment of All Spine Segments ın Individuals With Low Back Pain

NCT06276322 | Recruiting

• 1 other identifier: HU-FTR-SZK-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives.

Conditions

Low Back Pain

Keywords

Rehabilitation; Kinematics; Activities of Daily Living

Outcome Measures

Primary Outcomes (4)

• Evaluation of the kinematics of the all spine during walking

  Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for walking. Angular data in the atlanto-occipital, C7-T1, T8-T9, T12-L1, L3-L4, and L5-S1 segments will be recorded in 3-dimensional. Participants will walk on a 10-meter walking path.

  two months

• Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects

  Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Bending Forward and Lifting Objects. The box (5 kilograms ) will be centered 15 centimeter in front of the participants' toes. Spinal kinematics will be analyzed from bending forward to lift the box, to holding the box in front of the hips and standing straight.

  two months

• Evaluation of the kinematics of the all spine during Standing from Sitting

  Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Standing from Sitting. Participants will stand up with their arms crossed over their chest at their preferred pace.

  two months

• Evaluation of the kinematics of the all spine during Climbing Step

  Kinematic evaluations of functional activities will be performed using MVN Awinda (XSens Technologies B.V. Enschede, Netherlands) Inertial measurement unit sensors for Climbing Step. Each participant will be asked to step onto a single 24 centimeter tall rectangular step placed \~13 centimeter from the big toe at a self-selected pace

  two months

Secondary Outcomes (4)

• Spine Normal Joint Movement evaluation

  two months

• Pain intensity: Visual Analog Scale

  two months

• Oswestry Disability Index

  two months

• Fear of movement: Tampa Kinesiophobia Scale

  two months

Study Arms (2)

Low Back Pain Group

EXPERIMENTAL

Low back pain group will be evaluated the kinematics of all spine segments in 3 planes while performing the tasks that patients with chronic low back pain often describe as painful in their daily lives,

Other: Low back pain group

Healthy Group

ACTIVE COMPARATOR

Healthy Group's results will be compared them with low back pain group

Other: Healthy group

Interventions

Low back pain group OTHER

The low back pain group will be evaluated the kinematics of all spine segments in 3 planes while performing the tasks that patients with chronic low back pain often describe as painful in their daily lives such as walking, stepping up, standing up, bending and lifting. Using Inertial Measurement Sensors that provide valid and reliable will evaluate the kinematics of all spine

Low Back Pain Group

Healthy group OTHER

Low back pain kinematics compare them with asymptomatic kontrols

Healthy Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For the low back pain group:
• Individuals aged 18-55 with non-specific chronic low back pain
• Individuals who have been experiencing pain for more than 3 months
• Individuals whose pain intensity is above 3 on the Visual Analog Scale
• For the healthy group:
• \- Individuals aged 18-55 with no history of low back pain lasting more than 1 week for 6 months prior to the study

You may not qualify if:

• Current rheumatological or neurological diseases
• Recent or current pregnancy
• History of tumors or spine fractures
• Known spinal defects or surgery history
• Body mass index over 30 kg/m²

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe university

Ankara, Altındağ, 06050, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• Mitchell K, Porter M, Anderson L, Phillips C, Arceo G, Montz B, Levy S, Gombatto SP. Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study. BMC Musculoskelet Disord. 2017 Aug 25;18(1):369. doi: 10.1186/s12891-017-1721-z.

  PMID: 28841866 BACKGROUND

• Gombatto SP, Brock T, DeLork A, Jones G, Madden E, Rinere C. Lumbar spine kinematics during walking in people with and people without low back pain. Gait Posture. 2015 Oct;42(4):539-44. doi: 10.1016/j.gaitpost.2015.08.010. Epub 2015 Sep 3.

  PMID: 26380913 BACKGROUND

• Papi E, Bull AMJ, McGregor AH. Spinal segments do not move together predictably during daily activities. Gait Posture. 2019 Jan;67:277-283. doi: 10.1016/j.gaitpost.2018.10.031. Epub 2018 Oct 29.

  PMID: 30391750 BACKGROUND

• Laird RA, Keating JL, Ussing K, Li P, Kent P. Does movement matter in people with back pain? Investigating 'atypical' lumbo-pelvic kinematics in people with and without back pain using wireless movement sensors. BMC Musculoskelet Disord. 2019 Jan 18;20(1):28. doi: 10.1186/s12891-018-2387-x.

  PMID: 30658610 BACKGROUND

• Saito H, Watanabe Y, Kutsuna T, Futohashi T, Kusumoto Y, Chiba H, Kubo M, Takasaki H. Spinal movement variability associated with low back pain: A scoping review. PLoS One. 2021 May 24;16(5):e0252141. doi: 10.1371/journal.pone.0252141. eCollection 2021.

  PMID: 34029347 BACKGROUND

• Dogan M, Kocak M, Onursal Kilinc O, Ayvat F, Sutcu G, Ayvat E, Kilinc M, Unver O, Aksu Yildirim S. Functional range of motion in the upper extremity and trunk joints: Nine functional everyday tasks with inertial sensors. Gait Posture. 2019 May;70:141-147. doi: 10.1016/j.gaitpost.2019.02.024. Epub 2019 Feb 25.

  PMID: 30875600 BACKGROUND

• Papi E, Bull AMJ, McGregor AH. Is there evidence to use kinematic/kinetic measures clinically in low back pain patients? A systematic review. Clin Biomech (Bristol). 2018 Jun;55:53-64. doi: 10.1016/j.clinbiomech.2018.04.006. Epub 2018 Apr 11.

  PMID: 29684790 BACKGROUND

• Fong DT, Chan YY. The use of wearable inertial motion sensors in human lower limb biomechanics studies: a systematic review. Sensors (Basel). 2010;10(12):11556-65. doi: 10.3390/s101211556. Epub 2010 Dec 16.

  PMID: 22163542 BACKGROUND

• Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.

  PMID: 27262182 BACKGROUND

• Christe G, Aussems C, Jolles BM, Favre J. Patients With Chronic Low Back Pain Have an Individual Movement Signature: A Comparison of Angular Amplitude, Angular Velocity and Muscle Activity Across Multiple Functional Tasks. Front Bioeng Biotechnol. 2021 Nov 15;9:767974. doi: 10.3389/fbioe.2021.767974. eCollection 2021.

  PMID: 34869281 BACKGROUND

• Christe G, Rochat V, Jolles BM, Favre J. Lumbar and thoracic kinematics during step-up: Comparison of three-dimensional angles between patients with chronic low back pain and asymptomatic individuals. J Orthop Res. 2020 Jun;38(6):1248-1256. doi: 10.1002/jor.24575. Epub 2020 Jan 7.

  PMID: 31879969 BACKGROUND

• Aartun E, Axen I, Mior S, Roe Y, Hondras M, Kretz L, Cote P. Contextualizing the lived experiences of patients with low back pain from different countries according to the ICF framework. J Rehabil Med. 2021 May 11;53(5):jrm00189. doi: 10.2340/16501977-2819.

  PMID: 33778896 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sümeyye Zehra Güler, MSc

  +90 5079320390

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Zehra Güler, MSc

CONTACT

5079320390; zhrkzlk1906@gmail.com

Sevil Bilgin, Prof.

CONTACT

530 243 16 84; sevil.bilgin@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Low back pain group and healthy group

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 23, 2024
• Study Start: December 1, 2023
• Primary Completion: March 20, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)