Safety and Efficacy of PRP for Treatment of Disc Pain
|ClinicalTrials.gov Identifier: NCT04064866|
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Discogenic Pain||Device: High yield pure PRP Other: Placebo Device: ProPlaz PPC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
This is a multi-center, randomized, controlled, double-blind clinical trial comparing hemocyte autograft (platelet rich plasma) to control injection (placebo) in subjects with reported cervical, thoracic or lumbar pain for at least 3 months with Pfirrmann grade changes at 7 or less and who are being considered for discography in order to identify pain generator discs in evaluation of potential surgical candidates. Randomization ratio was 2:1. After 8 weeks subjects who received placebo are eligible for crossover to treatment arm with hemocyte autograft, and subject who received treatment arm are eligible for surgery if not improved.
For subjects who cross over, follow-up schedule will reset with visits at 8 weeks and 26 weeks post-crossover.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Investigator, care provider, and participant were all blinded to injection contents (e.g., hemocyte autograft intervention vs. placebo control) An independent blinded evaluator assessed subjects at 4 weeks and 8 weeks. An unblinded or blinded evaluator will assess subjects at 26 weeks.|
|Official Title:||A Multi-Center, Randomized, Controlled, Double-blind Study Evaluating Safety and Efficacy of Hemocyte Autograft for Treatment of Single-Level and Multi- Level Lumbar, Thoracic and Cervical Discogenic Pain|
|Actual Study Start Date :||May 17, 2016|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||February 18, 2019|
Experimental: PRP/Hemocyte Autograft Intervention Arm
All subjects will have blood drawn (50 cc) from any access site and have it prepared for hemocyte autograft. Using a 20 gauge introducer and 25 gauge disc needle, subjects randomized to active condition will have exactly 3 cc of hemocyte autograft placed in a 3 cc syringe. The syringe barrels and tubing were covered with opaque tape so that the injector was blinded to the contents. 1-2 cc of PRP was injected into the nucleus pulposus of each identified treatment level disc for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical.
Device: High yield pure PRP
The investigational product is hemocyte autograft derived from the subject's own blood. Subjects with a clinical diagnosis of discogenic pain had a discogram with ¼ cc to ½ cc of contrast injected by hand (leaving up to ½ cc contrast in the needle lumen and connecting tube); any concordant pain will be noted. Subjects received the injectant delineated by coordinator-provided randomization. Subjects were awake for the entirety of study treatment procedure.
All subjects had blood drawn (50 cc) from any access site and double-centrifuged using the EmCyte Hemocyte Autograft system; the first spin separated the buffy coat, the second spin and subsequent siphoning separated a purified platelet sample.
Other Name: PRP
Device: ProPlaz PPC
Trademarked name of an FDA-cleared product
Other Name: BioRich Medical ProPlaz Protein Plasma Concentrator
Placebo Comparator: Placebo Control Arm
All subjects will have blood drawn (50 cc) from any access site and have it prepared for hemocyte autograft. Using a 20 gauge introducer and 25 gauge disc needle, subjects randomized to placebo condition will have exactly 3 cc of saline placed in a 3 cc syringe. 1-2 cc of saline was injected into the nucleus pulposus of each identified treatment level disc for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical.
Placebo injections will have saline placed in centrifuges and run for the duration required for PRP preparation. 3cc of saline will be placed in 3 cc syringes with opaque tape around the barrel to cover the fluid chamber. 1-2 cc of saline will be injected into the nucleus pulposus of each treatment level disc under fluoroscopy for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical.
Other Name: Control
- Patient Specific Functional Scale (PSFS) [ Time Frame: 8 weeks from baseline ]
The primary objective of this study is to determine safety and efficacy of a single injection of hemocyte autograft into diseased discs for the treatment of back and neck pain. The PSFS is a self-report, patient-specific outcome measure designed to assess functional change in patients with pain and musculoskeletal disorders. The total score = the sum of the activity scores (10 maximum, which reflects a better level of functioning)/the number of activities (7 maximum). At least two points improvement on the average Pain Specific Functional
- Adverse Event Reporting [ Time Frame: Baseline to 26 weeks ]Adverse events (AEs) and any other untoward signs or symptoms were collected at each study timepoint starting at the treatment injection. Serious adverse events (SAEs) determined by the investigator to be related to the study treatment were formally recorded. [NOTE: NONE REPORTED THROUGHOUT STUDY DURATION]
- Numeric Pain Rating Scale (NRPS) [ Time Frame: 8 weeks from baseline ]The NRPS is a unidimensional measure of pain intensity for adults. The 11-point numeric scale ranges from '0' representing 'no pain' to 10 representing 'worst possible pain.' The NPRS can be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric scale value that best describes the intensity of their pain within the last 24-hours. Clinical improvement was denoted by at least 3 points improvement in Numeric Pain Rating Scale (NPRS)
- Oswestry Disability Index (ODI) [ Time Frame: 8 weeks from baseline ]A measure to gauge improvement in pain symptoms among lumbar and thoracic spine conditions. The ODI is a patient-based questionnaire which gives a subjective percentage score of functionality/disability for a list of activities of daily living among those rehabilitating from lower back pain. There are 6 statements scored from 0-5 (0 is the least pain/no pain, 5 is the greatest level of pain). Clinical improvement is characterized by more than 10% improvement in the ODI from baseline (calculated by [total scored/total possible score]*100).
- Neck Disability Index (NDI) [ Time Frame: 8 weeks from baseline ]The most commonly-used self-report measure to gauge improvement in pain symptoms among cervical spine conditions. The NDI is comprised of 10 items (each scored on a 0-5 rating scale, in which zero reflects "no pain" and five means "worst pain imaginable") including pain, personal care, reading, lifting, headaches, concentration, work ,driving, sleeping, and recreation. A higher score indicates greater level of disability. The NDI can be scored as a raw score of doubled and expressed as a percentile. 0-4 points (0-8%) = no disability. 5-14 points (10-28%) = mild disability. 15-24 points (30-48%) = moderate disability. 25-34 points (50-64%) = severe disability. 35-50 point (70-100%) = complete disability. Clinical improvement was indicated by improvement of at least 10% from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064866
|United States, California|
|Comprehensive Spine and Sports Center|
|Campbell, California, United States, 89148|
|Neurological Associates of West LA|
|Santa Monica, California, United States, 90403|
|The Spine Institute: Center for Spinal Restoration|
|Santa Monica, California, United States, 90403|
|Santa Monica, California, United States, 90405|
|United States, Georgia|
|Georgia Pain and Spine|
|Peachtree City, Georgia, United States, 30269|
|United States, Illinois|
|Millenium Pain Center|
|Chicago, Illinois, United States, 61704|
|United States, Texas|
|Precision Spine Care|
|Tyler, Texas, United States, 75701|
|Principal Investigator:||Sheldon E Jordan, M.D.||Neurological Associates of West Los Angeles|