RadiculopathyNCT01850771
Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
A study testing Regenexx PL-Disc and Steroid Epidural in people with Radiculopathy and Herniated Disc, run by Regenexx, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy, Herniated Disc, Disc Degeneration
- What is being tested?
- Regenexx PL-Disc and Steroid Epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2016
- 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
- Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years
- Significant functional disability related to pain, lack of strength, or other back or leg symptoms
- Physical examination consistent with lumbar radiculopathy
- Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Who cannot join
- Symptomatic central or foraminal stenosis
- Previous low back surgery
- Prior epidural steroid injection or other low back injection therapy within the past year
- >50% loss of disc height at the symptomatic level
- Spondylolisthesis
- Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
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- Quinolone or Statin induced myopathy/tendinopathy
- Severe neurogenic inflammation of the cutaneous nerves
- Condition represents a worker's compensation case
- Currently involved in a health-related litigation procedure
- Is pregnant
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Allergy or intolerance to study medication
- Use of chronic opioid,
- Documented history of drug abuse within six months of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months.
Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Read the detailed description
Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months.
Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination.
Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group.
Subjects will complete the study following the 1 year follow-up visit.
- Conditions
- Radiculopathy, Herniated Disc, Disc Degeneration
- Being tested
- Regenexx PL-Disc, Steroid Epidural
- Keywords
- Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenexx PL-DiscProcedure or surgery
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
Steroid EpiduralProcedure or surgery
Injection into the epidural space under image guidance of 3 mg of betamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Regenexx PL-Disc | Active comparator | Injection of Regenexx PL-Disc into the epidural space once a week for two weeks. Receives: Procedure: Regenexx PL-Disc |
| Steroid Epidural | Active comparator | Injection of steroid into the epidural space once a week for two weeks Receives: Procedure: Steroid Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Change from Baseline
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Oswestry Disability Index (ODI) scores.
Measured: Change from baseline to 3 months
Secondary outcomes (8)
Mean Functional Rating Index Scores
Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.
Measured: 6 weeks, 3 months, 6 months, 12 months
Mean ODI scores
Difference between treatment groups in mean ODI scores at each follow-up timepoint
Measured: 6 weeks, 3 months, 6 months, 12 months
Mean Pain Scales
Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
Measured: 6 weeks, 3 months, 6 months, 12 months
Incidence of Complications and Adverse Events
Incidence of post-operative complications and adverse events between treatment groups.
Measured: 12 months
Incidence of re-injection/re-operation
Incidence of re-injection and surgical operation between treatment groups.
Measured: 12 months
Use of pain medications
Difference between treatment groups in use of pain medications at each follow-up timepoint
Measured: 6 weeks, 3 months, 6 months, 12 months
Time to Resolution of Complications and Adverse Events
Time to resolution of post-operative complications and adverse events between treatment groups.
Measured: 12 months
Time to re-injection/re-operation
Time to re-injection and surgical operation between treatment groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850771
- Sponsor's protocol ID
- RSI2013-RCT02
- Status last verified
- Jun 2016
- First submitted
- 7 May 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT01850771
- Acronym / sponsor ID
- RSI2013-RCT02
- Conditions
- Radiculopathy, Herniated Disc, Disc Degeneration
- Keywords
- Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 May 2013 (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.
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months.
Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Detailed description
Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months.
Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination.
Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group.
Subjects will complete the study following the 1 year follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenexx PL-Disc | Active comparator | Procedure: Regenexx PL-DiscInjection of Regenexx PL-Disc into the epidural space once a week for two weeks. |
| Steroid Epidural | Active comparator | Procedure: Steroid EpiduralInjection of steroid into the epidural space once a week for two weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years
- Significant functional disability related to pain, lack of strength, or other back or leg symptoms
- Physical examination consistent with lumbar radiculopathy
- Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Key exclusion criteria (16 listed)
- Symptomatic central or foraminal stenosis
- Previous low back surgery
- Prior epidural steroid injection or other low back injection therapy within the past year
- >50% loss of disc height at the symptomatic level
- Spondylolisthesis
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 |
|---|---|---|
| Regenexx PL-DiscInjection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid. | Procedure or surgery | Regenexx PL-Disc |
| Steroid EpiduralInjection into the epidural space under image guidance of 3 mg of betamethasone. | Procedure or surgery | Steroid Epidural |
Primary outcome
Oswestry Disability Index Change from Baseline
Time frame: Change from baseline to 3 months
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Oswestry Disability Index (ODI) scores.
8 secondary outcomes
Mean Functional Rating Index Scores
Time frame: 6 weeks, 3 months, 6 months, 12 months
Mean ODI scores
Time frame: 6 weeks, 3 months, 6 months, 12 months
Mean Pain Scales
Time frame: 6 weeks, 3 months, 6 months, 12 months
Incidence of Complications and Adverse Events
Time frame: 12 months
Incidence of re-injection/re-operation
Time frame: 12 months
Use of pain medications
Time frame: 6 weeks, 3 months, 6 months, 12 months
Time to Resolution of Complications and Adverse Events
Time frame: 12 months
Time to re-injection/re-operation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- 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.
Christopher Centeno, MD principal investigator
Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenexx PL-Disc and Steroid Epidural in people with Radiculopathy and Herniated Disc, run by Regenexx, LLC at 1 site in United States.
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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Jun 2016. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment). 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?
Oswestry Disability Index Change from Baseline (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.