The Impact Of Fascia Thickness on Chronic Low Back Pain

Completed

• Conditions: Low Back Pain; Disability Physical; Pain, Chronic
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT06572007
• Lead Sponsor: Okan University

Brief Summary

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).

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 Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-24
• Study First Posted: 2024-08-26
• Study Start: 2024-09-15
• Status Verified: 2024-10
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low back pain	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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"
Lumbar Extensor Shortening Assessment	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
Straight Leg Raise Test (SLR)	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.

Secondary Outcome Measures

Name	Time	Method
Roland Morris Disability Questionnaire (RMDQ)	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 .
Beck Depression Inventory	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

Trial Locations

Locations (2)

Emine Atıcı; 🇹🇷 Tuzla, İstanbul, Turkey

Istanbul Okan University; 🇹🇷 Istanbul, Turkey