Sodium Hyaluronate for Myofascial Thoracic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEPC Education s.r.o.
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Thoracic back pain as the primary complaint
Localized tenderness
Paravertebral muscle spasm
Trigger points
Disqualifiers
Lack of written informed consent
Active malignancy
Recent trauma
Age > 70 years
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Hyaluronate Injection
Other interventionSodium hyaluronate injections added to standard lidocaine injection.
Saline Injections
Other interventionNormal saline added to standard lidocaine injection, which reflects current clinical practice.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
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)
Time frame
1, 3, and 6 months2
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 months3
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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