Using GelStix™ to treat chronic low back pain from disc degeneration
Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain
This study tests if the GelStix™ device can help people with chronic low back pain from disc problems who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ospedale Regionale di Lugano Academic / other |
| Locations | 2 sites (Arnhem and 1 other locations) |
| Trial ID | NCT02763956 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the GelStix™ device in treating chronic discogenic low back pain in patients who have not found relief from conservative treatments. It involves a comparison between patients receiving the GelStix™ treatment and a control group receiving a saline solution injection. The study aims to measure pain reduction, disability, quality of life, and patient-reported outcomes. The goal is to provide a less invasive alternative to traditional surgical options for patients suffering from degenerative disc disease.
Who should consider this trial
Good fit: Ideal candidates are adults with discogenic pain from degenerative disc disease who have not benefited from at least 12 weeks of conservative care.
Not a fit: Patients with radiculopathy, disc herniations, or those who have undergone previous lumbar surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer significant pain relief and improved quality of life for patients with chronic low back pain.
How similar studies have performed: While the GelStix™ device represents a novel approach, similar studies on less invasive treatments for degenerative disc disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * discogenic pain caused by one or two levels of degenerative disc disease, confirmed by MRI and positive discography * failure to have symptoms resolved or reduced following at least 12 weeks of conservative care (pain medication and/or physical therapy) * negative medial branches block results * baseline Numeric Rating Scale (NRS) pain score ≥5/10 Exclusion Criteria: * radiculopathy * disc herniations * annular tear (greater than Grade 4 Modified Dallas Grading) * coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation * previous lumbar surgery * disc height less than 5 mm at the treatment level or less than 50% the original height * BMI (Body Mass Index (kg/m2) of ≥ 35
Where this trial is running
Arnhem and 1 other locations
- Rijnstate Ziekenhuis — Arnhem, Netherlands (Recruiting)
- EOC Lugano — Lugano, Ticino, Switzerland (Recruiting)
Study contacts
- Principal investigator: Eva Koetsier, MD PhD LLM — Centro Terapia del Dolore, EOC Lugano
- Study coordinator: Eva Koetsier, MD PhD LLM
- Email: eva.koetsier@eoc.ch
- Phone: 0041918117590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.