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Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

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ClinicalTrials.gov Identifier: NCT01850771
Recruitment Status : Terminated (Difficulties in recruitment)
First Posted : May 9, 2013
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Brief 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.

Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.


Condition or disease Intervention/treatment Phase
Radiculopathy Herniated Disc Disc Degeneration Procedure: Regenexx PL-Disc Procedure: Steroid Epidural Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy
Study Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regenexx PL-Disc
Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.
Procedure: Regenexx PL-Disc
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.

Active Comparator: Steroid Epidural
Injection of steroid into the epidural space once a week for two weeks
Procedure: Steroid Epidural
Injection into the epidural space under image guidance of 3 mg of betamethasone.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mean Functional Rating Index Scores [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.

  2. Mean ODI scores [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    Difference between treatment groups in mean ODI scores at each follow-up timepoint

  3. Mean Pain Scales [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

  4. Incidence of Complications and Adverse Events [ Time Frame: 12 months ]
    Incidence of post-operative complications and adverse events between treatment groups.

  5. Incidence of re-injection/re-operation [ Time Frame: 12 months ]
    Incidence of re-injection and surgical operation between treatment groups.

  6. Use of pain medications [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
    Difference between treatment groups in use of pain medications at each follow-up timepoint

  7. Time to Resolution of Complications and Adverse Events [ Time Frame: 12 months ]
    Time to resolution of post-operative complications and adverse events between treatment groups.

  8. Time to re-injection/re-operation [ Time Frame: 12 months ]
    Time to re-injection and surgical operation between treatment groups.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850771


Locations
United States, Colorado
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
Sponsors and Collaborators
Regenexx, LLC
Investigators
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic

Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT01850771     History of Changes
Other Study ID Numbers: RSI2013-RCT02
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Regenexx, LLC:
Lumbar Radiculopathy
Disc bulge
Disc herniation
Disc degeneration

Additional relevant MeSH terms:
Radiculopathy
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical