Spinal Stenosis LumbarPhase 4GOLDSTENNCT04492774
Degenerative Lumbar Stenosis Conservative Treatment
A Phase 4 study testing Goldic serum, Steroid injections and Manual therapy in people with Spinal Stenosis Lumbar and Spinal Canal Stenosis, run by Sutherland Medical Center at 1 site in Poland.
Trial summary
The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar, Spinal Canal Stenosis
- What is being tested?
- Goldic serum, Steroid injections and Manual therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs of lumbar spinal stenosis
- Radiological signs of lumbar spinal stenosis confirmed by MRI
- No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Mental state allowing cooperation during manual therapy
- An adult who consents to participate in the study
- No previous surgery or spinal epidural injections
Who cannot join
- The presence of serious neurological deficits
- Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
- Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Previous surgery or spinal epidural injections of lumbar spine
- Mental state preventing cooperation during manual therapy
- Lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial
The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.
Read the detailed description
BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for patients over 65 years of age. It is assumed that in the United States alone, it affects about 200 thousand patients causing significant impairment of their quality of life. Although it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion, facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of DLSS management, especially in the group of older patients, is still the matter of debate. Three main concepts of conservative treatment are considered: 1) pharmacological care - symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections, 2) rehabilitations protocols and mechanical devices like traction facilities or corsets to decompress spinal canal or support in case of instability, 3) biological - stimulation of anti-inflammatory action and regeneration capacity by biologically active substances. All methods are offered without strong evidence of its efficacy.
AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections, manual therapy in the concept of spinal canal venous drainage.
Research hypothesis: The use of Goldic serum in epidural injections improves the condition of patients with DLSS during the observation period longer than steroid injections and the rehabilitation protocol.
DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients, single-centre study. POPULATION: the local adult population METHODS: Three groups of patients (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions according to the inclusion and exclusion criteria. There will be 30 people in each group (90 people in total).
Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of serum (4 doses of 3 ml in total), injections performed into the epidural space under ultrasound control by the same operator.
Group B - steroid therapy with Dexaven 4 mg / 1 ml - 2 injections at weekly intervals containing single doses of dexamethasone (total dose of 8 mg), injections will be performed into the epidural space under ultrasound control by the same operator.
Group C - manual therapy according to the concept of venous drainage - a repeatable treatment scheme for each patient; decompression of the thoracic outlet, diaphragm release, sacroiliac joints (SI) mobilizations, rib-sternum release, rib raising technique - 4 sessions (1 x weekly - approx. 40 min).
Control tools: NRS Pain Scale (0-10), Oswestry Disability Index, Zurich Claudication Questionnaire (ZCQ), EQ-5D-5L, Control points: Initial Assessment (IA), 4,12, 24 weeks after last intervention.
- Conditions
- Spinal Stenosis Lumbar, Spinal Canal Stenosis
- Being tested
- Goldic serum, Steroid injections, Manual therapy
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goldic serumCombination product
Also called Autologous serum
epidural injections
Steroid injectionsDrug
Also called Dexamethasone
epidural injections
Manual therapyProcedure or surgery
Also called drainage
Veno-lymphatic drainage
| Study group | Role | What they receive |
|---|---|---|
| GOLDIC serum | Experimental | Epidural ultrasound guided injections Receives: Combination Product: Goldic serum |
| Steroid | Active comparator | Epidural ultrasound guided injections Receives: Drug: Steroid injections |
| Manual therapy | Active comparator | veno-lymphatic spinal drainage Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EQ-5D-5L index from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 24 weeks
Change in Oswestry Disability Index from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Measured: Change from baseline to 24 weeks
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks
Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
Measured: Change from baseline to 24 weeks
Secondary outcomes (9)
Change in pain intensity according to Numeric Rating Scale
Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
Measured: Change from baseline to 4 weeks
Change in pain intensity according to Numeric Rating Scale
Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
Measured: Change from baseline to 12 weeks
Change in pain intensity according to Numeric Rating Scale
Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
Measured: Change from baseline to 24 weeks
Change in EQ-5D-5L index from baseline to 4 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 4 weeks
Change in EQ-5D-5L index from baseline to 12 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 12 weeks
Change in Oswestry Disability Index from baseline to 4 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Measured: Change from baseline to 4 weeks
Change in Oswestry Disability Index from baseline to 12 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Measured: Change from baseline to 12 weeks
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks
Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
Measured: Change from baseline to 4 weeks
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks
Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 Spinal Stenosis LumbarStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutherland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Godek, Sutherland Medical Center
- Investigators
- Piotr Godek, PhD, Principal investigator, Sutherland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492774
- Sponsor's protocol ID
- SMC2020002
- Acronym
- GOLDSTEN
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godek P, Szczepanowska-Wolowiec B, Golicki D. GOLDIC therapy in degenerative lumbar spinal stenosis: randomized, controlled trial. Regen Med. 2022 Oct;17(10):709-718. doi: 10.2217/rme-2022-0047. Epub 2022 Jul 28.
PubMed 35899459
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04492774
- Acronym / sponsor ID
- GOLDSTEN / SMC2020002
- Conditions
- Spinal Stenosis Lumbar, Spinal Canal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sutherland Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- 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.
The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.
Detailed description
BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for patients over 65 years of age. It is assumed that in the United States alone, it affects about 200 thousand patients causing significant impairment of their quality of life. Although it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion, facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of DLSS management, especially in the group of older patients, is still the matter of debate. Three main concepts of conservative treatment are considered: 1) pharmacological care - symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections, 2) rehabilitations protocols and mechanical devices like traction facilities or corsets to decompress spinal canal or support in case of instability, 3) biological - stimulation of anti-inflammatory action and regeneration capacity by biologically active substances. All methods are offered without strong evidence of its efficacy.
AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections, manual therapy in the concept of spinal canal venous drainage.
Research hypothesis: The use of Goldic serum in epidural injections improves the condition of patients with DLSS during the observation period longer than steroid injections and the rehabilitation protocol.
DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients, single-centre study. POPULATION: the local adult population METHODS: Three groups of patients (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions according to the inclusion and exclusion criteria. There will be 30 people in each group (90 people in total).
Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of serum (4 doses of 3 ml in total), injections performed into the epidural space under ultrasound control by the same operator.
Group B - steroid therapy with Dexaven 4 mg / 1 ml - 2 injections at weekly intervals containing single doses of dexamethasone (total dose of 8 mg), injections will be performed into the epidural space under ultrasound control by the same operator.
Group C - manual therapy according to the concept of venous drainage - a repeatable treatment scheme for each patient; decompression of the thoracic outlet, diaphragm release, sacroiliac joints (SI) mobilizations, rib-sternum release, rib raising technique - 4 sessions (1 x weekly - approx. 40 min).
Control tools: NRS Pain Scale (0-10), Oswestry Disability Index, Zurich Claudication Questionnaire (ZCQ), EQ-5D-5L, Control points: Initial Assessment (IA), 4,12, 24 weeks after last intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| GOLDIC serum | Experimental | Combination Product: Goldic serumEpidural ultrasound guided injections |
| Steroid | Active comparator | Drug: Steroid injectionsEpidural ultrasound guided injections |
| Manual therapy | Active comparator | Procedure: Manual therapyveno-lymphatic spinal drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical signs of lumbar spinal stenosis
- Radiological signs of lumbar spinal stenosis confirmed by MRI
- No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Mental state allowing cooperation during manual therapy
- An adult who consents to participate in the study
Key exclusion criteria (6 listed)
- The presence of serious neurological deficits
- Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
- Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- Previous surgery or spinal epidural injections of lumbar spine
- Mental state preventing cooperation during manual therapy
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 |
|---|---|---|
| Goldic serumAlso: Autologous serumepidural injections | Combination product | GOLDIC serum |
| Steroid injectionsAlso: Dexamethasoneepidural injections | Drug | Steroid |
| Manual therapyAlso: drainageVeno-lymphatic drainage | Procedure or surgery | Manual therapy |
Primary outcome
Change in EQ-5D-5L index from baseline to 24 weeks
Time frame: Change from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Change in Oswestry Disability Index from baseline to 24 weeks
Time frame: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks
Time frame: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
9 secondary outcomes
Change in pain intensity according to Numeric Rating Scale
Time frame: Change from baseline to 4 weeks
Change in pain intensity according to Numeric Rating Scale
Time frame: Change from baseline to 12 weeks
Change in pain intensity according to Numeric Rating Scale
Time frame: Change from baseline to 24 weeks
Change in EQ-5D-5L index from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Change in EQ-5D-5L index from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Change in Oswestry Disability Index from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Change in Oswestry Disability Index from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks
Time frame: Change from baseline to 4 weeks
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 35899459Godek P, Szczepanowska-Wolowiec B, Golicki D. GOLDIC therapy in degenerative lumbar spinal stenosis: randomized, controlled trial. Regen Med. 2022 Oct;17(10):709-718. doi: 10.2217/rme-2022-0047. Epub 2022 Jul 28.
- Individual participant dataSharing planned: No
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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.
Piotr Godek, PhD principal investigator
Sutherland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Goldic serum, Steroid injections and Manual therapy in people with Spinal Stenosis Lumbar and Spinal Canal Stenosis, run by Sutherland Medical Center at 1 site in Poland.
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 6 inclusion and 6 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EQ-5D-5L index from baseline to 24 weeks (time frame: Change from baseline to 24 weeks). The study lists 3 primary outcomes in all. 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 NCT04492774, 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 11 Mar 2021.