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

Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Procedure: Myofascial Release; Drug: 5% dextrose injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barış NACIR, Professor Doctor; Phone Number: +905327278724; Email: drbarisnacir@gmail.com
• Study Contact Backup: Name: Büşra ALÇIN, Medical Doctor; Phone Number: +905413528952; Email: drbusraalcin@gmail.com

Study Locations

• Turkey (Türkiye)
  • Altındağ
    • Ankara, Altındağ, Turkey (Türkiye), 06230
      • Recruiting
      • Ankara Training and Research Hospital
      • Contact: Barış NACIR, Professor Doctor; Phone Number: +905327278724; Email: drbarisnacir@gmail.com
      • Contact: Büşra ALÇIN, Medical Doctor; Phone Number: +905413528952; Email: drbusraalcin@gmail.com
      • Principal Investigator: Büşra ALÇIN, Medical Doctor
      • Sub-Investigator: Nida KOÇER NAZLIGÜL, Medical Doctor
      • Sub-Investigator: Barış NACIR, Professor Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracolumbar Fascia Mobilization Group; 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.	Procedure: 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.; Other Names: Thoracolumbar Fascia Mobilization
Active Comparator: Thoracolumbar Interfascial 5% Dextrose Injection Group; Patients in this group will receive ultrasound-guided thoracolumbar interfascial 5% dextrose injection. After being informed about the procedure, the patient will be placed in the prone position on the examination table, with a small pillow placed under the abdomen to allow relaxation of the lumbar muscles. Axial scanning will be performed using a Logiq 9 (GE Medical Systems®) ultrasound device equipped with a linear probe (7-12 MHz, "ZONARE"), and the probe will be positioned at the level of the L3 spinous process. The multifidus, longissimus, and iliocostalis muscles will be visualized. A 21-gauge (0.80 × 38 mm) needle will then be inserted from lateral to medial into the interfascial plane of the posterior layer of the thoracolumbar fascia using an in-plane technique. After confirming negative aspiration (to rule out vascular puncture), 10 mL of 5% dextrose solution will be injected into the target area.	Drug: 5% dextrose injection; 10 mL of 5% dextrose solution will be injected into the target area.; Other Names: Ultrasound-Guided 5% Dextrose Injection
Active Comparator: Combined Therapy Group; Patients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.	Procedure: 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.; Other Names: Thoracolumbar Fascia Mobilization; Drug: 5% dextrose injection; 10 mL of 5% dextrose solution will be injected into the target area.; Other Names: Ultrasound-Guided 5% Dextrose Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, after 1 month and 3 month changes
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.	Baseline, after 1 month and 3 month changes
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.	Baseline, after 1 month and 3 month changes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, after 1 month and 3 month changes
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.	Baseline, after 1 month and 3 month changes
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.	Baseline, after 1 month and 3 month changes

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Collaborators: Ankara Training and Research Hospital
• Investigators: Principal Investigator: Büşra ALÇIN, Medical Doctor, Ankara Training and Research Hospital; Study Director: Nida KOÇER NAZLIGÜL, Medical Doctor, Ankara Training and Research Hospital; Study Director: Barış NACIR, Ankara Training and Research Hospital

Publications and helpful links

General Publications

• Langevin HM, Fox JR, Koptiuch C, Badger GJ, Greenan-Naumann AC, Bouffard NA, Konofagou EE, Lee WN, Triano JJ, Henry SM. Reduced thoracolumbar fascia shear strain in human chronic low back pain. BMC Musculoskelet Disord. 2011 Sep 19;12:203. doi: 10.1186/1471-2474-12-203.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mobilization; Thoracolumbar Fascia; Dextrose Injection
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Carbohydrates; Rehabilitation; Sugars; Hexoses; Monosaccharides; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Glucose; Myofascial Release Therapy
• Other Study ID Numbers: 2025/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No