NCT05174091

Brief Summary

Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. NSLBP creates many health problems due to uncertainties in both its diagnosis and treatment. Due to the health problems and decreased functional activities of the individual, it creates a socioeconomic burden on both the individual and the country. NSLBP ranks 6th in the distribution of the economic burden caused by diseases to developed and developing societies. It is difficult to calculate how much burden it puts on the country's economy both directly (health institutions) and indirectly (loss of working days). However, in 1996 in the United States (USA), the economic burden of NSLBP patients is estimated to be between 18.5 and 28.2 million.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

December 13, 2021

Last Update Submit

July 20, 2022

Conditions

Keywords

FunctionalMovementScreenCoreEndurancePhysical capacity

Outcome Measures

Primary Outcomes (2)

  • Functional Movement Screening (FMS) (Functional Movement Patterns)

    FMS will be used to evaluate the quality of 7 functional movement patterns with the goal of identifying movement limitations and asymmetries. The FMS consists of 7 individual test items including the deep squat, in-line lunge, hurdle step, shoulder flexibility, push-up, straight leg raise, and rotary trunk stability assessment. Each of these 7 test items is graded on a scale of 0-3; thus, the lowest and highest possible overall FMS scores are 0 and 21, respectively.

    1 day

  • Spinal Mobility

    Spinal mobility will be measured with a computer-assisted portable electromechanical device (the Spinal Mouse System, Idiag, Fejraltorf, Switzerland). Measurements will be made with the participant's back naked. Spinous processes between C7 and S3 of the individual will be marked before spinal mouse measurement is made. The C7 spinous process is located between the two rounds of the spinal mouse. It will go down to the S3 vertebra with a speed of 6.7 cm/sec, which measures without disturbing the patient's position. Then, the same measurements will be made between the C7 spinous process and the S3 spinous process while the person is in the position of maximum flexion, extension and right-left lateral flexion.

    1 day

Secondary Outcomes (9)

  • Oswetry Disability Index

    1 day.

  • Functional Reach Test

    1 day.

  • Two Minutes Step Test

    1 day.

  • Time Up and Go Test

    1 day.

  • The Trunk Flexor Endurance Test

    1 day

  • +4 more secondary outcomes

Study Arms (2)

With Non- Spesific Low Back Pain

FMS, Spinal mobility, Core Endurance, Physical Capacity.

Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity

Without Non- Spesific Low Back Pain

FMS, Spinal mobility, Core Endurance, Physical Capacity.

Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity

Interventions

Due to the difficulties in the diagnosis and treatment of NSLBP, it has been causing many problems such as limitation of activation, socioeconomic burden, and biopsychosocial factors for years. It is thought that the effectiveness of treatment will increase if the needs and problems of individuals with NSLBP are clearly revealed beforehand. Although there are studies on core endurance and physical capacities in individuals with NSLBP in the literature, the number of studies examining functional movement analysis and spinal mobility in individuals with NSLBP is very few. Therefore, aim of this research is to compare functional movement analysis, physical capacity, core endurance, and spinal mobility in individuals with and without NSLBP. With the results we will reveal, we aim to contribute to the evaluation and treatment of patients with NSLBP. Thus, the negative effects of this pathology, which causes serious labor and financial losses, can be minimized.

With Non- Spesific Low Back PainWithout Non- Spesific Low Back Pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-65, • having pain between the last rib and inferior gluteal region more than 3 months

You may qualify if:

  • Being between the ages of 18-65,
  • getting more than 24 points in the minimental test,
  • having pain between the last rib and inferior gluteal region,
  • being diagnosed with NSLBP, presence of low back pain for more than 3 months, -volunteering to participate in the study.
  • Being between the ages of 18-65,
  • getting over 24 points in the minimental test,
  • not having low back pain in the last 3 months,
  • volunteering to participate in the study were determined.

You may not qualify if:

  • uncontrollable hypertension and heart disease,
  • uncontrollable neurological and metabolic disease,
  • trauma history in the last 6 months,
  • serious musculoskeletal problem and other pathology that may adversely affect balance,
  • severe mental involvement, lower extremity amputation,
  • presence of nerve pressure, non-voluntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykent University

Istanbul, Beylikdüzü, 34100, Turkey (Türkiye)

Location

Related Publications (4)

  • Ahmadi H, Adib H, Selk-Ghaffari M, Shafizad M, Moradi S, Madani Z, Partovi G, Mahmoodi A. Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial. Clin Rehabil. 2020 Dec;34(12):1449-1457. doi: 10.1177/0269215520947069. Epub 2020 Jul 29.

    PMID: 32723088BACKGROUND
  • Kellis E, Adamou G, Tzilios G, Emmanouilidou M. Reliability of spinal range of motion in healthy boys using a skin-surface device. J Manipulative Physiol Ther. 2008 Oct;31(8):570-6. doi: 10.1016/j.jmpt.2008.09.001.

    PMID: 18984239BACKGROUND
  • Vachalathiti R, Sakulsriprasert P, Kingcha P. Decreased Functional Capacity in Individuals with Chronic Non-Specific Low Back Pain: A Cross-Sectional Comparative Study. J Pain Res. 2020 Aug 5;13:1979-1986. doi: 10.2147/JPR.S260875. eCollection 2020.

    PMID: 32801853BACKGROUND
  • Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther. 2006 May;1(2):62-72.

    PMID: 21522216BACKGROUND

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 30, 2021

Study Start

December 1, 2021

Primary Completion

April 30, 2022

Study Completion

June 1, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations