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Thoracic PainNCT07775274

Sodium Hyaluronate for Myofascial Thoracic Pain

A study testing Sodium Hyaluronate Injection and Saline Injections in people with Thoracic Pain and Back Pain, run by EPC Education s.r.o..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To determine whether the addition of sodium hyaluronate to standard ultrasoundguided lidocaine injection provides superior and sustained pain relief compared with standard lidocaine injection alone in patients with suspected myofascial or nonspecific thoracic back pain. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Thoracic Pain, Back Pain
What is being tested?
Sodium Hyaluronate Injection and Saline Injections
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
31 Aug 2026to 20 Feb 2029
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Thoracic back pain as the primary complaint
  • Clinically significant myofascial contribution, defined by at least two of the following:
  • Localized tenderness
  • Paravertebral muscle spasm
  • Trigger points
  • Reduced skin or fascial mobility
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  • Persistent pain despite at least 6 weeks of conservative treatment
  • Absence of more specific causes of pain, as determined by clinical examination and additional investigations when indicated
  • Age over 18 years
  • Conditions to be excluded prior to enrollment include:
  • Neuropathic pain patterns, including:
  • Cervical or thoracic radicular pain
  • Intercostal neuralgia
  • Dorsal scapular neuralgia
  • Other neuralgias of thoracic region
  • Pleural pain patterns
  • Ischemic pain patterns (e.g., ischemic heart disease)
  • Predominantly postural pain associated with female sex and osteopenia suggestive of vertebral compression fractures

Who cannot join

  • Lack of written informed consent
  • Active malignancy
  • Recent trauma
  • Age > 70 years
  • Local or systemic infection
  • Presence of another more likely pain etiology
Show all 9Show fewer
  • Severe scoliosis and/or significant chest wall deformity
  • History of thoracic or upper abdominal surgery
  • History of spinal surgery of any kind

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Michal Matias, MD, FIPP contact

+420602246127

matias@europainclinics.com

About this study

Official title: Sodium Hyaluronate for Myofascial Thoracic Pain: A Randomized Double-blind Controlled Trial

To determine whether the addition of sodium hyaluronate to standard ultrasoundguided lidocaine injection provides superior and sustained pain relief compared with standard lidocaine injection alone in patients with suspected myofascial or nonspecific thoracic back pain.

Read the detailed description

The myofascial complex is increasingly recognized as a potential source of thoracic back pain. Sodium hyaluronate is a key component of synovial fluid and has more recently been recognized as an important element of interfascial spaces. The hypothesized mechanism of action of sodium hyaluronate differs from that of local anesthetic agents and is expected to influence outcome timing. Sodium hyaluronate is a key determinant of interfascial lubrication and viscoelastic behavior, facilitating low-friction gliding between adjacent fascial layers. Experimental and biomechanical studies suggest that alterations in sodium hyaluronate concentration or molecular organization may increase interfascial shear resistance, potentially contributing to nociceptive input through abnormal tissue strain and impaired movement patterns. Restoration of sodium hyaluronate is therefore postulated to improve fascial sliding and mechanical load distribution rather than producing immediate analgesia. Although corticosteroids are used by some clinicians as part of injection-based management of spinal and myofascial pain, they were intentionally not included in the present study. The primary objective of this trial was to evaluate the incremental effect of interfascial sodium hyaluronate on pain and function while minimizing pharmacological confounding and potential long-term tissue effects. This trial is designed as a superiority study evaluating the incremental benefit of sodium hyaluronate compared to normal saline added to standard lidocaine injection, which reflects current clinical practice. For this purpose, a clear, colorless, viscoelastic 1% sodium hyaluronate saline solution (10 mg/ml) in a sterile package for single use, was used. Participants will be randomized in a 1:1 ratio by computer-generated random sequence into two groups. Group 1. Interventional - (4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate) or Group 2. - control group receiving standard lidocaine injection with saline (4 mL of 1% lidocaine followed by 12 ml of normal saline). Group 2. is a control group with no sodium hyaluronate administration; however, the administration of lidocaine represents a standard procedure, so patients will not be left without treatment even in this study arm. All procedures will be performed by two experienced physicians using a standardized technique. Patients will be positioned prone in the procedure room. The transverse processes at the level corresponding to maximal tenderness will be identified using ultrasound guidance.

Being tested
Sodium Hyaluronate Injection, Saline Injections
Keywords
myofascial complex, sodium hyaluronate, ultrasound-guided, thoracic back pain
Medical subject headings
Chest Pain, Back Pain

What participants receive

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

  • Sodium Hyaluronate InjectionOther

    Sodium hyaluronate injections added to standard lidocaine injection.

  • Saline InjectionsOther

    Normal saline added to standard lidocaine injection, which reflects current clinical practice.

Study groups in NCT07775274
Study groupRoleWhat they receive
Group 1Experimental4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate
Receives: Other: Sodium Hyaluronate Injection
Group 2Active comparator4 mL of 1% lidocaine followed by 12 mL of normal saline
Receives: Other: Saline Injections

What is being measured

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

  1. Numeric Rating Scale (NRS) for Pain

    Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain

    Measured: 1, 3, and 6 months

Secondary outcomes (3)
  1. EQ-5D standardized questionnaire used to measure health-related quality of life

    EQ index, Scale from 0 (state equivalent to death) to 1 (full health); Scale 0 - 100, where 0 (state equivalent to death) and 100 (full health)

    Measured: 1, 3, and 6 months

  2. Pain, Enjoyment of Life, and General Activity (PEG) Assessment

    Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)

    Measured: 1, 3, and 6 months

  3. Global Rating of Change (GRC)

    Retrospective assessment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement)

    Measured: 1, 3, and 6 months

Timeline

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

  1. First posted20 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2029 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07775274
Sponsor's protocol ID
KS_EPCcz_2026/003
Status last verified
Jul 2026
First submitted
17 Aug 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sodium Hyaluronate Injection and Saline Injections in people with Thoracic Pain and Back Pain, run by EPC Education s.r.o..

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 18 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Michal Matias, MD, FIPP (+420602246127, matias@europainclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale (NRS) for Pain (time frame: 1, 3, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Aug 2026.

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