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..
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
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- 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.
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.
- Conditions
- Thoracic Pain, Back Pain
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate Receives: Other: Sodium Hyaluronate Injection |
| Group 2 | Active comparator | 4 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.
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)
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
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
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.
- First posted20 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Hyaluronate for Myofascial Thoracic Pain: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07775274
- Acronym / sponsor ID
- KS_EPCcz_2026/003
- Conditions
- Thoracic Pain, Back Pain
- Keywords
- myofascial complex, sodium hyaluronate, ultrasound-guided, thoracic back pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2029 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Sodium Hyaluronate Injection4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate |
| Group 2 | Active comparator | Other: Saline Injections4 mL of 1% lidocaine followed by 12 mL of normal saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Thoracic back pain as the primary complaint
- Clinically significant myofascial contribution, defined by at least two of the following:
- 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
Key exclusion criteria (9 listed)
- Lack of written informed consent
- Active malignancy
- Recent trauma
- Age > 70 years
- Local or systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Hyaluronate InjectionSodium hyaluronate injections added to standard lidocaine injection. | Other | Group 1 |
| Saline InjectionsNormal saline added to standard lidocaine injection, which reflects current clinical practice. | Other | Group 2 |
Primary outcome
Numeric Rating Scale (NRS) for Pain
Time frame: 1, 3, and 6 months
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
3 secondary outcomes
EQ-5D standardized questionnaire used to measure health-related quality of life
Time frame: 1, 3, and 6 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Time frame: 1, 3, and 6 months
Global Rating of Change (GRC)
Time frame: 1, 3, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.