Sodium Hyaluronate for Myofascial Thoracic Pain
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 20, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 20, 2029
August 20, 2026
July 1, 2026
6 months
August 17, 2026
August 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale (NRS) for Pain
Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
1, 3, and 6 months
Secondary Outcomes (3)
EQ-5D standardized questionnaire used to measure health-related quality of life
1, 3, and 6 months
Pain, Enjoyment of Life, and General Activity (PEG) Assessment
1, 3, and 6 months
Global Rating of Change (GRC)
1, 3, and 6 months
Study Arms (2)
Group 1
EXPERIMENTAL4 mL of 1% lidocaine followed by 12 mL of sodium hyaluronate
Group 2
ACTIVE COMPARATOR4 mL of 1% lidocaine followed by 12 mL of normal saline
Interventions
Sodium hyaluronate injections added to standard lidocaine injection.
Normal saline added to standard lidocaine injection, which reflects current clinical practice.
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 20, 2026
Study Start
August 31, 2026
Primary Completion (Estimated)
February 20, 2027
Study Completion (Estimated)
February 20, 2029
Last Updated
August 20, 2026
Record last verified: 2026-07