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Completed

NCT Number: NCT06572007

The Impact Of Fascia Thickness on 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).

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emine Atıcı, Tuzla, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: baseline

    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"

  2. Straight Leg Raise Test (SLR)

    Time frame: baseline

    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.

  3. Lumbar Extensor Shortening Assessment

    Time frame: baseline

    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

Secondary outcomes

  1. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: baseline

    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 .

  2. Beck Depression Inventory

    Time frame: baseline

    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

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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