RCT Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain GelStix Study
Unknown statusNot applicableNCT02763956
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population with discogenic pain that had no benefit from conservative care.
Study details
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain
- Conditions
- Degeneration of Lumbar Intervertebral Disc
- Interventions
- Device: GelStix™ Nucleus Augmentation Device
- Other: Placebo
- Sponsor
- Ospedale Regionale di Lugano
- Collaborators
- Rijnstate Ziekenhuis, Arnhem, The Netherlands; Paolo Maino, Sponsor-Investigator
- Start date
- 2016-04
- Primary completion
- 2025-07
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands, Switzerland
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02763956