Degeneration of Lumbar Intervertebral DiscGelStixNCT02763956
RCT Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain GelStix Study
A study testing GelStix™ Nucleus Augmentation Device in people with Degeneration of Lumbar Intervertebral Disc, run by Ospedale Regionale di Lugano at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- What is being tested?
- GelStix™ Nucleus Augmentation Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate Ziekenhuis
Arnhem
Jan Willem Kallewaard, 0031(0)88 - 005 8888,, jkallewaard@rijnstate.nl
Switzerland1 site, 1 recruiting
- Recruiting
EOC Lugano
Lugano, Canton Ticino, 6962
Eva Koetsier, MD PhD LLM, 0041918117595, eva.koetsier@eoc.ch; evakoetsier6@gmail.com
Paolo Maino, MD PhD, 0041918117590, paolo.maino@eoc.ch
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain
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.
Read the detailed description
Degenerative Disc Disease (DDD) is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The degeneration is associated with diminished water-binding capabilities of the nucleus pulpous leading to disc dehydration, volume reduction, changes in cellular activity, biomechanical changes and painful symptoms. Patients are initially treated with non-surgical pain-management techniques, such as anti-inflammatory medications and physical therapy, but these therapies often provide only temporary relief. When non-surgical intervention fails, fusion or total disc arthroplasty are often prescribed, both of which are highly invasive surgeries with significant associated morbidity. Clearly, a meaningful solution for the treatment gap existing between conservative care and invasive surgical intervention is needed.
The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population that had no benefit from conservative care.
The primary objective of this study is to quantify the reduction in lumbar pain in a GelStix™ treatment group compared with a control group receiving a saline solution injection as placebo.
The secondary objectives are to assess:
- Disability, using the Oswestry Disability Index (ODI)
- Quality of life (QoL), quantified with the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).
- The Patient's Global Impression of Change (PGIC) scale. This scale assesses the patient's own evaluation of improvement or deterioration over time on a 7-point Likert Scale rated from 'very much improved' to 'very much worse'.
- The use of pain medication
- The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline. Pfirrmann grade, disc height, and the presence of high intensity zones, Modic signs, and Schmorl's nodes will be recorded.
- The incidence and severity of complications and adverse events
The total expected number of patients to be randomized is 72. Taking into account a relevant difference of 1.5 between groups on the NRS, with an SD of 2, 30 patients per group (60 patients in total) will be required to detect a statistically significant difference with a power of 80% at an alpha of 5% (two-tailed) for unpaired Student's T test. Taking into account a 20% drop out rate, 72 patients are expected to be randomized for this study.
The estimated duration for the investigational plan (from start of screening of first participant to end of follow-up of last participant) is 24 months.
- Being tested
- GelStix™ Nucleus Augmentation Device, Placebo
- Keywords
- Gelstix, Hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelStix™ Nucleus Augmentation DeviceDevice
Also called Hydrogel
Intradiscal Gelstix insertion
PlaceboOther
Also called Saline, NaCl 0,9%
Intradiscal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Gelstix | Experimental | The intradiscal insertion of the GelStix™ Nucleus Augmentation Device. Receives: Device: GelStix™ Nucleus Augmentation Device |
| Placebo | Placebo comparator | Intradiscal saline solution (1 mL NaCl 0.9%) injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lumbar Pain intensity measured on Numeric Rating Scale
Pain intensity will be assessed employing an 11-point (i.e. 0-10) NRS with 0 meaning 'no pain' and '10' meaning 'worst possible pain'. Three times daily pain scores will be assessed for five consecutive days around the intended measurement time.
Measured: The mean NRS scores on the pain diary will be measured at baseline, and at one week, and one, three, six (primary outcome) and twelve months.
Secondary outcomes (6)
Changes in disability measured by the Owestry Disability Index
The ODI is a self-administered questionnaire, assessing the patient's level of pain and function during basic activities of daily living such as walking, personal care, standing, sleeping, etc.
Measured: The ODI is completed at baseline, and at three, six and twelve months.
Changes in health related quality of life measured by EuroQualityOfLife-5 dimensions questionnaire
This questionnaire assesses health related quality of life in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.49 Additionally, the EuroQol Visual Analogue Scale (EQ VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine'.
Measured: The EQ-5D-5L will be completed at baseline and at three, six and twelve months.
The Patient's Global Impression of Change (PGIC) scale
This scale assesses the patient's own evaluation of improvement or deterioration over time on a 7-point Likert Scale rated from 'very much improved' to 'very much worse'.
Measured: The Patient's Global Impression of Change (PGIC) scale will be measured at three, six and twelve months.
Pain medication
Reliance on medication to relieve pain: type and dose of analgesics
Measured: The use of pain medication will be assessed as the intake of analgesics at baseline, at one week, and at one, three, six and twelve months.
The disc degeneration process
Pfirrmann grade, disc height, and the presence of high intensity zones (HIZ), Modic signs, and Schmorl's nodes will be recorded.
Measured: The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline.
The incidence and severity of complications and adverse events
The safety outcome of this study is the incidence and severity of complications and adverse events (AE's) including procedure-related complications at any time point in the study.
Measured: The incidence and severity of complications and adverse events are assessed at any time point in the study up to one year follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Ziekenhuis, Arnhem, The Netherlands, Paolo Maino, Sponsor-Investigator
- Responsible party
- Principal investigator, Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano
- Investigators
- Eva Koetsier, MD PhD LLM, Principal investigator, Centro Terapia del Dolore, EOC Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763956
- Sponsor's protocol ID
- GelStix-SW/ NSI-TD-003
- Acronym
- GelStix
- Status last verified
- Feb 2022
- First submitted
- 29 Apr 2016
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koetsier E, van Kuijk SMJ, Maino P, Dukanac J, Scascighini L, Cianfoni A, Scarone P, Kuhlen DE, Hollman MW, Kallewaard JW. Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial. BMJ Open. 2022 Mar 30;12(3):e053772. doi: 10.1136/bmjopen-2021-053772.
PubMed 35354635
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT02763956
- Acronym / sponsor ID
- GelStix / GelStix-SW/ NSI-TD-003
- Keywords
- Gelstix, Hydrogel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Collaborators
- Rijnstate Ziekenhuis, Arnhem, The Netherlands, Paolo Maino, Sponsor-Investigator
- Study start
- Apr 2016
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Degenerative Disc Disease (DDD) is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The degeneration is associated with diminished water-binding capabilities of the nucleus pulpous leading to disc dehydration, volume reduction, changes in cellular activity, biomechanical changes and painful symptoms. Patients are initially treated with non-surgical pain-management techniques, such as anti-inflammatory medications and physical therapy, but these therapies often provide only temporary relief. When non-surgical intervention fails, fusion or total disc arthroplasty are often prescribed, both of which are highly invasive surgeries with significant associated morbidity. Clearly, a meaningful solution for the treatment gap existing between conservative care and invasive surgical intervention is needed.
The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population that had no benefit from conservative care.
The primary objective of this study is to quantify the reduction in lumbar pain in a GelStix™ treatment group compared with a control group receiving a saline solution injection as placebo.
The secondary objectives are to assess:
- Disability, using the Oswestry Disability Index (ODI)
- Quality of life (QoL), quantified with the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).
- The Patient's Global Impression of Change (PGIC) scale. This scale assesses the patient's own evaluation of improvement or deterioration over time on a 7-point Likert Scale rated from 'very much improved' to 'very much worse'.
- The use of pain medication
- The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline. Pfirrmann grade, disc height, and the presence of high intensity zones, Modic signs, and Schmorl's nodes will be recorded.
- The incidence and severity of complications and adverse events
The total expected number of patients to be randomized is 72. Taking into account a relevant difference of 1.5 between groups on the NRS, with an SD of 2, 30 patients per group (60 patients in total) will be required to detect a statistically significant difference with a power of 80% at an alpha of 5% (two-tailed) for unpaired Student's T test. Taking into account a 20% drop out rate, 72 patients are expected to be randomized for this study.
The estimated duration for the investigational plan (from start of screening of first participant to end of follow-up of last participant) is 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelstix | Experimental | Device: GelStix™ Nucleus Augmentation DeviceThe intradiscal insertion of the GelStix™ Nucleus Augmentation Device. |
| Placebo | Placebo comparator | Other: PlaceboIntradiscal saline solution (1 mL NaCl 0.9%) injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelStix™ Nucleus Augmentation DeviceAlso: HydrogelIntradiscal Gelstix insertion | Device | Gelstix |
| PlaceboAlso: Saline, NaCl 0,9%Intradiscal saline injection | Other | Placebo |
Primary outcome
Change in Lumbar Pain intensity measured on Numeric Rating Scale
Time frame: The mean NRS scores on the pain diary will be measured at baseline, and at one week, and one, three, six (primary outcome) and twelve months.
Pain intensity will be assessed employing an 11-point (i.e. 0-10) NRS with 0 meaning 'no pain' and '10' meaning 'worst possible pain'. Three times daily pain scores will be assessed for five consecutive days around the intended measurement time.
6 secondary outcomes
Changes in disability measured by the Owestry Disability Index
Time frame: The ODI is completed at baseline, and at three, six and twelve months.
Changes in health related quality of life measured by EuroQualityOfLife-5 dimensions questionnaire
Time frame: The EQ-5D-5L will be completed at baseline and at three, six and twelve months.
The Patient's Global Impression of Change (PGIC) scale
Time frame: The Patient's Global Impression of Change (PGIC) scale will be measured at three, six and twelve months.
Pain medication
Time frame: The use of pain medication will be assessed as the intake of analgesics at baseline, at one week, and at one, three, six and twelve months.
The disc degeneration process
Time frame: The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline.
The incidence and severity of complications and adverse events
Time frame: The incidence and severity of complications and adverse events are assessed at any time point in the study up to one year follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Derived from this study: PubMed 35354635Koetsier E, van Kuijk SMJ, Maino P, Dukanac J, Scascighini L, Cianfoni A, Scarone P, Kuhlen DE, Hollman MW, Kallewaard JW. Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial. BMJ Open. 2022 Mar 30;12(3):e053772. doi: 10.1136/bmjopen-2021-053772.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Koetsier, MD PhD LLM principal investigator
Centro Terapia del Dolore, EOC Lugano
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GelStix™ Nucleus Augmentation Device in people with Degeneration of Lumbar Intervertebral Disc, run by Ospedale Regionale di Lugano at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Koetsier, MD PhD LLM (0041918117590, eva.koetsier@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lumbar Pain intensity measured on Numeric Rating Scale (time frame: The mean NRS scores on the pain diary will be measured at baseline, and at one week, and one, three, six (primary outcome) and twelve months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.