An interventional study of Sodium Hyaluronate Injection and Saline Injections in Thoracic Pain and Back Pain, sponsored by EPC Education s.r.o.. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by EPC Education s.r.o. · Not applicable, Interventional, and Treatment
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.
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.
388 studies on the registry are indexed under Chest Pain; 64 are open to participants now.
This study's planned enrollment of 100 is below the median of 129 across 204 interventional studies indexed under Chest Pain.
Browse Chest Pain studies →EPC Education s.r.o. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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myofascial contribution, defined by at least two of the following:
Conditions to be excluded prior to enrollment include:
Neuropathic pain patterns, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate
Other: Sodium Hyaluronate Injection
4 mL of 1% lidocaine followed by 12 mL of normal saline
Other: Saline Injections
Sodium hyaluronate injections added to standard lidocaine injection.
Normal saline added to standard lidocaine injection, which reflects current clinical practice.
Numeric Rating Scale (NRS) for Pain
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
Time frame: 1, 3, and 6 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 1, 3, and 6 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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EPC Education s.r.o.