Ireland
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Recruiting Not applicable

Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided 5% Dextrose Injection in Chronic Low Back Pain

NCT07241559 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2026-05-07

Condition(s) studied

Chronic Low Back Pain

Investigational drug(s) / intervention(s)

5% dextrose injectionMyofascial Release

5% dextrose injection: 10 mL of 5% dextrose solution will be injected into the target area.

Myofascial Release: Patients in this group will receive thoracolumbar fascia mobilization. A total of six sessions of myofascial release therapy will be administered twice per week for three weeks.

Study summary

The aim of this study is to investigate the effects of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection on pain, range of motion, disability, quality of life, proprioception, and fascial thickness and echogenicity in patients with nonspecific chronic low back pain.

-Primary Objective: The primary objective is to evaluate the effects of these interventions on pain, functional status and range of motion.

-Secondary Objective: The secondary objective is to assess the long-term effects on quality of life, proprioception, fascial thickness, and echogenicity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female patients aged 18 to 65 years 2. Presence of low back pain lasting longer than 3 months 3. No adequate response to medical treatment 4. Voluntary participation in the study Exclusion Criteria: 1. Age below 18 or above 65 years 2. Body mass index (BMI) greater than 30 kg/m² 3. Pregnancy or breastfeeding 4. Presence of coagulation disorders 5. History of spinal surgery 6. Presence of inflammatory or malignant diseases 7. Local infection at the spine or injection site 8. Presence of lumbar disc pathology causing radiculopathy 9. Presence of spinal stenosis, spondylolysis, or spondylolisthesis 10. Participation in physical therapy or any manual therapy within the past 6 months 11. Receiving lumbar injections within the past 6 months 12. History of allergy to injection materials 13. Refusal to participate in the study

Primary outcome measure(s)

  • Visual Analog Scale (VAS) — Baseline, after 1 month and 3 month changes
    Patients' back pain scores will be recorded using a VAS (Visual Analog Scale). The VAS method used to assess pain intensity is a scale from 0 (no pain) to 10 (unbearable pain), with the patient selecting the number that corresponds to their pain.
  • Lumbar spine range of motion (ROM) — Baseline, after 1 month and 3 month changes
    Lumbar spine range of motion (ROM) was assessed using a dual digital inclinometer and the Modified Schober Test. For inclinometer measurements, a Baseline® Digital Inclinometer (Fabrication Enterprises Inc., USA) was used. Participants stood with feet shoulder-width apart and knees extended. The spinous processes of T12 and S1 were palpated and marked as reference points. One inclinometer was placed on T12 and the other on S1, and both were zeroed in the neutral position. Participants performed lumbar flexion, extension, and lateral flexion slowly without knee flexion or pelvic rotation. Lumbar ROM was calculated as the difference between the angular readings at T12 and S1. Each movement was measured three times and the mean value was used for analysis. Lumbar flexion was also assessed using the Modified Schober Test.
  • Functional Status Assessment (Oswestry Disability Index - ODI) — Baseline, after 1 month and 3 month changes
    Functional status was assessed using the Oswestry Disability Index (ODI), one of the most commonly used and validated questionnaires for evaluating disability related to low back pain. The ODI consists of 10 sections, each addressing a different aspect of daily living affected by back pain, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or homemaking. Each item is scored on a 6-point Likert scale ranging from 0 (no disability) to 5 (maximum disability). The total score is calculated by summing the responses, dividing by the maximum possible score, and multiplying by 100 to obtain a percentage of disability. Higher scores indicate greater functional limitation. Participants completed the ODI questionnaire at baseline and after the intervention to assess changes in functional status over time.

Trial sites (1)

FacilityCityRegionStatus
Ankara Training and Research Hospital Ankara Altındağ Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07241559 on ClinicalTrials.gov ↗ ← All trials in Turkey