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RecruitingNCT06537219Updated Aug 5, 2024

Changes in Thoracolumbar Fascia Stiffness and Pain Parameters in Young Patients With Chronic Low Back Pain

An observational study in Pain, Back Pain and Fascia, sponsored by Atılım University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by Atılım University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.

Read the detailed description

Non-specific low back pain has become a serious public health problem in latest years. The prevalence of low back pain is reported to be 84% in lifetime (1). Recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions .

This study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group.

Both groups underwent assessments related to pain properties. Specifically, the Numerical Pain Scale(NMS) will be used to assess subjective pain intensity(4), the Digital Algometer for assessing pressure pain treshold(5), the Pain Sensitivity Scale(PSS) pain sensitivity(6) and the Myotonometer MyotonPRO biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the TFL at the level of Lumbal 1,3 vertebrae(L1,L3) and under 12th costa (7-10). SPSS 23.0 will be used for statistical analysis. p\<0.05 is considered statistically significant.

02

Conditions studied

  • Pain
  • Back Pain
  • Fascia

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Keywords

  • non-spesific back pain
  • thoracolumbar fascia
  • stiffness
  • pain thresold
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Academic staff and university students at Atılım University will constitude the study population.

Sample size is calculated with 85% power. 50 participants( 25 experiment,25 control group) will be included in the study

Inclusion criteria

  • chronic back pain participants more than 3 months

Exclusion criteria

Exclusion Criteria:

  • Those with orthopaedic, neurological and systemic diseases will be excluded from the study.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • back pain group

    participants with chronic back pain( pain duration at least 3 months) aged between 18 and 50 years , male and female participanst will be included in the study. Those with orthopaedic, neurological and systemic diseases will be excluded from the study.

    Other: Assessment

  • control group

    healty male and female participants aged between 18 and 50 years

    Other: Assessment

Interventions

  • OtherAssessment

    Assessment of pain severity,pain thresold of the fascia, pain sensitivity

05

What researchers measure

Primary outcomes

  1. Numerical Pain Scale(NMS

    pain assessment

    Time frame: 1 month

  2. Fascia stiffness

    thoracolumbar fascia stiffness assessment

    Time frame: 1month

  3. the Pain Sensitivity Scale(PSS)

    Pain sensitivity assessment

    Time frame: month

06

Study locations

1 of 1 sites recruiting
  • Atılım University
    Ankara, 06830, Turkey
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06537219
Lead sponsor
Atılım University
Responsible party
NAİME ULUG (Assistant Professor, Atılım University) — Principal investigator
First posted
Aug 5, 2024
Start date
Jul 15, 2024
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 15, 2024 (estimated)
Last update
Aug 5, 2024

Study contacts

Naime Uluğ, PT,PhD
Contact
ulugnaime@gmail.com
05365434409
Süleyman Korkusuz, PT,PhD
Contact
suleyman.korkusuz@atilim.edu.tr
05388675480

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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