Chronic Low Back Pain
Conditions
Keywords
Dextrose Injection, Mobilization, Thoracolumbar Fascia
Brief 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.
Detailed description
This study aims to compare the effectiveness of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection in individuals with nonspecific chronic low back pain. The study will evaluate the impact of these interventions on pain intensity, lumbar range of motion, functional disability, quality of life, proprioception, and the structural characteristics of the thoracolumbar fascia. The primary objective is to determine how these treatment approaches influence pain severity, functional status, and lumbar mobility. The secondary objective is to explore their potential long-term effects on quality of life, lumbar proprioception, and thoracolumbar fascia morphology, including fascial thickness and echogenicity. Participants will be assigned to one of three groups. The first group will receive thoracolumbar fascia mobilization using standardized myofascial release techniques applied to the thoracolumbar fascia region. The intervention will be administered twice per week for three weeks, for a total of six treatment sessions. The procedure will be performed by the research team using standardized myofascial release techniques aimed at improving fascial mobility and reducing soft tissue restrictions. The second group will undergo ultrasound-guided thoracolumbar interfascial injection with 5% dextrose. The procedure will be performed in the prone position using a high-resolution ultrasound device with a linear probe to identify the relevant paraspinal structures. A needle will be advanced into the interfascial plane of the posterior layer of the thoracolumbar fascia under ultrasound guidance, and 10 mL of 5% dextrose solution will be injected after confirming the absence of vascular puncture. Participants in the third group will receive a combination of both interventions, including thoracolumbar fascia mobilization and ultrasound-guided interfascial dextrose injection, according to the protocols described above. Outcome assessments will include pain intensity measured by the Visual Analog Scale (VAS), lumbar range of motion assessed with a digital inclinometer and the Modified Schober Test, and functional disability evaluated using the Oswestry Disability Index (ODI). Additional secondary outcomes will include quality of life measured with the Short Form-12 Health Survey (SF-12), ultrasound-based evaluation of thoracolumbar fascia thickness and echogenicity, and lumbar proprioception assessed through an active joint position sense test. All outcome measures will be recorded at baseline and at follow-up evaluations at one and three months after the intervention. Participants eligible for inclusion in this study will be male or female patients aged between 18 and 65 years who have experienced low back pain lasting longer than three months and have not achieved adequate improvement with medical treatment. Participation in the study will be voluntary. Participants will be excluded if they are younger than 18 years or older than 65 years, have a body mass index (BMI) greater than 30 kg/m², are pregnant or breastfeeding, have coagulation disorders, have a history of spinal surgery, have inflammatory or malignant diseases, have a local infection at the spine or injection site, have lumbar disc pathology causing radiculopathy, have spinal stenosis, spondylolysis, or spondylolisthesis, have participated in physical therapy or any manual therapy within the past six months, have received lumbar injections within the past six months, have a history of allergy to injection materials, or refuse to participate in the study.
Interventions
10 mL of 5% dextrose solution will be injected into the target area.
PROCEDUREMyofascial 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.
Sponsors
Ankara City Hospital Bilkent
Ankara Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessment | Baseline, after 1 month and 3 month changes | Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12), a validated and widely used self-reported questionnaire designed to evaluate overall health status. The SF-12 measures both physical and mental health components, summarized as the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Participants completed the SF-12 questionnaire at baseline and after the intervention. Each item was scored according to the standardized SF-12 scoring algorithm, and results were converted into normalized scores (mean = 50, standard deviation= 10) to allow comparison with general population norms. Higher scores indicate better perceived health status and quality of life. The SF-12 has been validated for use in musculoskeletal and chronic pain populations and is suitable for evaluating treatment-related changes in functional health and well-being. |
| Thoracolumbar Fascia Thickness and Echogenicity Assessment | Baseline, after 1 month and 3 month changes | Thoracolumbar fascia (TLF) morphology was evaluated using ultrasound imaging, following the methodology described by Langevin et al. The ultrasound probe was positioned transversely at the L2-L3 interspinous level, where the thoracolumbar fascia lies parallel to the skin surface. High-resolution B-mode ultrasound images of the thoracolumbar fascia were obtained and recorded for each participant under standardized conditions. The thickness and echogenicity of the fascia were analyzed using ImageJ® software (National Institutes of Health, USA), a freely available image processing program. Fascial thickness was measured as the distance between the superficial and deep fascial borders, and echogenicity was quantified using grayscale intensity analysis within a standardized region of interest (ROI). All ultrasound assessments were performed by the same experienced physiatrist to ensure measurement reliability. |
| Lumbar Proprioception Assessment | Baseline, after 1 month and 3 month changes | Lumbar proprioception was evaluated using an active joint position sense test performed in the sitting position. Participants were seated comfortably with their pelvis stabilized and were instructed to move their trunk from a neutral starting position to a predetermined target angle in the sagittal plane (flexion or extension). After reaching the target position, participants maintained the posture for a few seconds to familiarize themselves with it, then returned to the starting (neutral) position. Following three practice trials involving maximal flexion and extension, each participant was asked to reproduce the target position without visual feedback. The repositioning error-the difference between the target angle and the angle reproduced by the participant-was measured using a universal goniometer. Three measurements were obtained, and the mean repositioning error was recorded for analysis. Smaller errors indicated better proprioceptive accuracy. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBarış NACIR, Professor Doctor
CONTACTBüşra ALÇIN, Medical Doctor
PRINCIPAL_INVESTIGATORBüşra ALÇIN, Medical Doctor
Ankara Training and Research Hospital
STUDY_DIRECTORNida KOÇER NAZLIGÜL, Medical Doctor
Ankara Training and Research Hospital
STUDY_DIRECTORBarış NACIR
Ankara Training and Research Hospital
Outcome results
None listed