The Impact Of Fascia Thickness on Chronic Low Back Pain

Relationships of Fascia Thickness With Pain, Flexibility, Disability and Depression in Individuals With Chronic Low Back Pain

This study aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP).

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Pain, Chronic; Disability Physical
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

This study investigates the role of the thoracolumbar fascia (TLF) in chronic low back pain (CLBP) persisting for more than one year. Specifically, the researchers aim to examine the relationships between various factors in individuals with CLBP, including the thickness of the perimuscular and subcutaneous regions in the lumbar and hamstring regions. The relationship with functional tests of the lower back and lower limbs will also be analysed. In addition, the intensity of the pain experienced by the participants, the extent to which the pain restricts their daily activities, and depression scores will be assessed. Through this analysis, the researchers aim to gain a deeper understanding of TLF's involvement in CLBP and its impact on the overall well-being of affected individuals.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34959
    • Istanbul Okan University
  • İstanbul
    • Tuzla, İstanbul, Turkey
      • Emine Atıcı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Getting a diagnosis of low back pain

Description

Inclusion Criteria:

• The absence of LBP in the last 12 months,
• A body mass index (BMI) of 18.5 to 30,
• An age between 30 and 50 years.

Exclusion Criteria:

• History of musculoskeletal diseases,
• a history of back and lower limb surgery,
• the use of anti-inflammatory drugs and steroids

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Low back pain; Fascia thickness of individuals with chronic low back pain will be measured by ultrasound and the relationship with pain, flexibility, disability and depression will be analysed.

Diagnostic test: Ultrasound; To investigate the thickness of the fascia tissue, the subjects will undergo an ultrasound examination using a clinical ultrasound system (S9, SonoScape Corporation, made in China) with a linear 5-14 MHz array of L14-5/38. The transducer with a cross-section of 6.24 cm2 will be aimed at points 2 cm lateral to the midline of the L2 and L3 vertebrae on both sides of the spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	The Visual Analog Scale, a 100 mm long scale marked at every 10 mm and ranging from 0 to 10, will be used to assess the level of pain. Patients mark their own pain level on this scale, scoring between 0 and 10, where 0 indicates "no pain" and 10 represents "the worst possible pain"	baseline
Straight Leg Raise Test (SLR)	The Straight Leg Raise Test is a physiotherapy method used to determine the range of motion of the hip joint. The patient lies supine. They are instructed to lift one leg as high as possible without bending the knee. The leg that remains on the ground should not lift, and its knee should remain extended. The point reached by the raised leg is measured with a goniometer. The same procedure is repeated for the other leg . Normally, the hip flexion angle is 90 degrees; a range of 70-90 degrees is considered normal in adults. An angle below 70 degrees indicates restriction.	baseline
Lumbar Extensor Shortening Assessment	This physiotherapy method is used to evaluate the shortening of the extensor muscles in the lumbar region. The patient lies supine with their arms in a reverse 'T' position. They are instructed to flex both hips and knees and draw them towards their abdomen. The distance between the knees and the chest is recorded	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire (RMDQ)	The Turkish version of the Roland Morris Disability Questionnaire will be used to measure disability. The RMDQ, first published in 1983, assesses the disability level of individuals with back pain(23). It consists of 24 items, including physical ability/activity (15 items), sleep/rest (3 items), psychosocial (2 items), home management (2 items), eating (1 item), and pain frequency (1 item). The original 24-item questionnaire has been shortened to 18-item and 23-item versions and adapted for use in other countries . It was adapted into Turkish by Küçükdeveci et al. in 2001. Each positive response corresponds to one point on the scale, addressing daily activities potentially restricted by back pain. Each "Yes" answer scores 1 point, and each "No" answer scores 0 points, with the final score being the sum of these points. The total score ranges from 0 to 24, with higher scores indicating greater disability .	baseline
Beck Depression Inventory	The Turkish version of the Beck Depression Inventory, developed by Beck and colleagues, will be used. Adapted into Turkish by Hisli N. in 1988, the inventory consists of 21 questions, each separately scored to obtain a total score. The possible scores range from 0 to 63. Scores of 0-9 indicate minimal depression, 10-16 mild depression, 17-29 moderate depression, and 30-63 severe depression	baseline

Collaborators and Investigators

• Sponsor: Okan University
• Investigators: Study Director: Emine Atıcı, Okan University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 24, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Low Back Pain
• Other Study ID Numbers: 26.10.2022/159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No