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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara City Hospital Bilkent

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged 18 to 65 years

Presence of low back pain lasting longer than 3 months

No adequate response to medical treatment

Voluntary participation in the study

Disqualifiers

Age below 18 or above 65 years

Body mass index (BMI) greater than 30 kg/m²

Pregnancy or breastfeeding

Presence of coagulation disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5% dextrose injection

    Drug

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

  • Myofascial Release

    Procedure/Surgery

    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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Thoracolumbar Fascia Mobilization GroupActive comparator 1 intervention
Group B: Thoracolumbar Interfascial 5% Dextrose Injection GroupActive comparator 1 intervention
Group C: Combined Therapy GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS)

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.

Time frame
Baseline, after 1 month and 3 month changes
2

Lumbar spine range of motion (ROM)

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.

Time frame
Baseline, after 1 month and 3 month changes
3

Functional Status Assessment (Oswestry Disability Index - ODI)

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.

Time frame
Baseline, after 1 month and 3 month changes

Secondary outcomes

1

Quality of Life Assessment

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.

Time frame
Baseline, after 1 month and 3 month changes
2

Thoracolumbar Fascia Thickness and Echogenicity Assessment

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.

Time frame
Baseline, after 1 month and 3 month changes
3

Lumbar Proprioception Assessment

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.

Time frame
Baseline, after 1 month and 3 month changes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Ankara Training and Research Hospital

Collaborator