- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07775274
Sodium Hyaluronate for Myofascial Thoracic Pain
19. august 2026 oppdatert av: EPC Education s.r.o.
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Michal Matias, MD, FIPP
- Telefonnummer: +420602246127
- E-post: matias@europainclinics.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- Lack of written informed consent
- Active malignancy
- Recent trauma
- Age > 70 years
- Local or systemic infection
- Presence of another more likely pain etiology
- Severe scoliosis and/or significant chest wall deformity
- History of thoracic or upper abdominal surgery
- History of spinal surgery of any kind
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group 1
4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate
|
Sodium hyaluronate injections added to standard lidocaine injection.
|
|
Aktiv komparator: Group 2
4 mL of 1% lidocaine followed by 12 mL of normal saline
|
Normal saline added to standard lidocaine injection, which reflects current clinical practice.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Rating Scale (NRS) for Pain
Tidsramme: 1, 3, and 6 months
|
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
|
1, 3, and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
EQ-5D standardized questionnaire used to measure health-related quality of life
Tidsramme: 1, 3, and 6 months
|
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)
|
1, 3, and 6 months
|
|
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
Tidsramme: 1, 3, and 6 months
|
Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
|
1, 3, and 6 months
|
|
Global Rating of Change (GRC)
Tidsramme: 1, 3, and 6 months
|
Retrospective assessment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement)
|
1, 3, and 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
31. august 2026
Primær fullføring (Antatt)
20. februar 2027
Studiet fullført (Antatt)
20. februar 2029
Datoer for studieregistrering
Først innsendt
17. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KS_EPCcz_2026/003
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