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

NCT07241559 | Recruiting

• 1 other identifier: 2025/5
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Dextrose Injection; Mobilization; Thoracolumbar Fascia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• Quality of Life Assessment

  Baseline, after 1 month and 3 month changes

• Thoracolumbar Fascia Thickness and Echogenicity Assessment

  Baseline, after 1 month and 3 month changes

• Lumbar Proprioception Assessment

  Baseline, after 1 month and 3 month changes

Study Arms (3)

Thoracolumbar Fascia Mobilization Group

ACTIVE COMPARATOR

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

Thoracolumbar Interfascial 5% Dextrose Injection Group

ACTIVE COMPARATOR

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

Combined Therapy Group

ACTIVE COMPARATOR

Patients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.

Drug: 5% dextrose injection; Procedure: Myofascial Release

Interventions

5% dextrose injection DRUG

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

Also known as: Ultrasound-Guided 5% Dextrose Injection

Combined Therapy Group; Thoracolumbar Interfascial 5% Dextrose Injection Group

Myofascial Release PROCEDURE

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.

Also known as: Thoracolumbar Fascia Mobilization

Combined Therapy Group; Thoracolumbar Fascia Mobilization Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age below 18 or above 65 years
• Body mass index (BMI) greater than 30 kg/m²
• Pregnancy or breastfeeding
• Presence of coagulation disorders
• History of spinal surgery
• Presence of inflammatory or malignant diseases
• Local infection at the spine or injection site
• Presence of lumbar disc pathology causing radiculopathy
• Presence of spinal stenosis, spondylolysis, or spondylolisthesis
• Participation in physical therapy or any manual therapy within the past 6 months
• Receiving lumbar injections within the past 6 months
• History of allergy to injection materials
• Refusal to participate in the study

Sponsors & Collaborators

• Ankara Training and Research Hospital: collaborator
• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 21929806 BACKGROUND

MeSH Terms

Interventions

Glucose; Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Büşra ALÇIN, Medical Doctor

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Nida KOÇER NAZLIGÜL, Medical Doctor

  Ankara Training and Research Hospital

  STUDY DIRECTOR

• Barış NACIR

  Ankara Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Barış NACIR, Professor Doctor

CONTACT

+905327278724; drbarisnacir@gmail.com

Büşra ALÇIN, Medical Doctor

CONTACT

+905413528952; drbusraalcin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)