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Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Primary Purpose

Radiculopathy, Herniated Disc, Disc Degeneration

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Regenexx PL-Disc

Steroid Epidural

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Regenexx PL-Disc

Steroid Epidural

Arm Description

Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.

Injection of steroid into the epidural space once a week for two weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Functional Rating Index Scores

Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.

Mean ODI scores

Difference between treatment groups in mean ODI scores at each follow-up timepoint

Mean Pain Scales

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

Incidence of Complications and Adverse Events

Incidence of post-operative complications and adverse events between treatment groups.

Incidence of re-injection/re-operation

Incidence of re-injection and surgical operation between treatment groups.

Use of pain medications

Difference between treatment groups in use of pain medications at each follow-up timepoint

Time to Resolution of Complications and Adverse Events

Time to resolution of post-operative complications and adverse events between treatment groups.

Time to re-injection/re-operation

Time to re-injection and surgical operation between treatment groups.

Full Information

NCT ID

NCT01850771

First Posted

May 7, 2013

Last Updated

June 1, 2016

Sponsor

Regenexx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01850771

Brief Title

Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Official Title

A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Difficulties in recruitment

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenexx, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiculopathy, Herniated Disc, Disc Degeneration

Keywords

Lumbar Radiculopathy, Disc bulge, Disc herniation, Disc degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regenexx PL-Disc

Arm Type

Active Comparator

Arm Description

Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.

Arm Title

Steroid Epidural

Arm Type

Active Comparator

Arm Description

Injection of steroid into the epidural space once a week for two weeks

Intervention Type

Procedure

Intervention Name(s)

Regenexx PL-Disc

Intervention Description

Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.

Intervention Type

Procedure

Intervention Name(s)

Steroid Epidural

Intervention Description

Injection into the epidural space under image guidance of 3 mg of betamethasone.

Primary Outcome Measure Information:

Title

Oswestry Disability Index Change from Baseline

Description

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.

Time Frame

Change from baseline to 3 months

Secondary Outcome Measure Information:

Title

Mean Functional Rating Index Scores

Description

Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.

Time Frame

6 weeks, 3 months, 6 months, 12 months

Title

Mean ODI scores

Description

Difference between treatment groups in mean ODI scores at each follow-up timepoint

Time Frame

6 weeks, 3 months, 6 months, 12 months

Title

Mean Pain Scales

Description

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

Time Frame

6 weeks, 3 months, 6 months, 12 months

Title

Incidence of Complications and Adverse Events

Description

Incidence of post-operative complications and adverse events between treatment groups.

Time Frame

12 months

Title

Incidence of re-injection/re-operation

Description

Incidence of re-injection and surgical operation between treatment groups.

Time Frame

12 months

Title

Use of pain medications

Description

Difference between treatment groups in use of pain medications at each follow-up timepoint

Time Frame

6 weeks, 3 months, 6 months, 12 months

Title

Time to Resolution of Complications and Adverse Events

Description

Time to resolution of post-operative complications and adverse events between treatment groups.

Time Frame

12 months

Title

Time to re-injection/re-operation

Description

Time to re-injection and surgical operation between treatment groups.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Centeno, MD

Organizational Affiliation

Centeno-Schultz Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centeno-Schultz Clinic

City

Broomfield

State/Province

Colorado

ZIP/Postal Code

80021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

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