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Chronic Low Back PainNCT07241559

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

A study testing 5% dextrose injection and Myofascial Release in people with Chronic Low Back Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Low Back Pain
What is being tested?
5% dextrose injection and Myofascial Release
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Barış NACIR, Professor Doctor contact

+905327278724

drbarisnacir@gmail.com

Büşra ALÇIN, Medical Doctor contact

+905413528952

drbusraalcin@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Training and Research Hospital

    Ankara, Altındağ, 06230

    Büşra ALÇIN, Medical Doctor, +905413528952, drbusraalcin@gmail.com

    Barış NACIR, Professor Doctor, +905327278724, drbarisnacir@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
5% dextrose injection, Myofascial Release
Keywords
Dextrose Injection, Mobilization, Thoracolumbar Fascia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5% dextrose injectionDrug

    Also called Ultrasound-Guided 5% Dextrose Injection

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

  • Myofascial ReleaseProcedure or surgery

    Also called Thoracolumbar Fascia Mobilization

    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 groups in NCT07241559
Study groupRoleWhat they receive
Thoracolumbar Fascia Mobilization GroupActive comparatorPatients 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.
Receives: Procedure: Myofascial Release
Thoracolumbar Interfascial 5% Dextrose Injection GroupActive comparatorPatients 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.
Receives: Drug: 5% dextrose injection
Combined Therapy GroupActive comparatorPatients in this group will receive both myofascial release therapy and ultrasound-guided thoracolumbar interfascial 5% dextrose injection as described above.
Receives: Drug: 5% dextrose injection; Procedure: Myofascial Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, after 1 month and 3 month changes

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, after 1 month and 3 month changes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start1 Nov 2025
  3. Primary completion1 Apr 2026
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241559
Sponsor's protocol ID
2025/5
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21929806

Questions about this trial

What is this clinical trial studying?

A study testing 5% dextrose injection and Myofascial Release in people with Chronic Low Back Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barış NACIR, Professor Doctor (+905327278724, drbarisnacir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: Baseline, after 1 month and 3 month changes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07241559, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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Clinical Trial NCT07241559 | AzTrials