Safety and Efficacy of PRP for Treatment of Disc Pain

Neurological Associates of West Los Angeles

Status: Completed

Conditions: Discogenic Pain

Treatments: Device: High yield pure PRP; Device: ProPlaz PPC; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04064866

31135/1

Details and patient eligibility

About

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.

Full description

The study will recruit 180 subjects: 60 suffering from lumbar discogenic pain, 60 suffering from thoracic discogenic pain and 60 suffering from cervical discogenic pain. In each arm 40 study subjects will be randomized to receive hemocyte autograft, while 20 will be randomized to receive contrast as the control group. 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 while subjects randomized to placebo will have exactly 3 cc of saline placed in a 3 cc syringe. The syringe barrels and tubing will be completely covered with opaque tape so that the injector is blinded to the contents. For both conditions, 1-2 cc of designated injectant (PRP for active, saline for placebo) will be 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. Primary endpoint will be at 8 weeks after injection. 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female at least 18 years of age.
2. Clinically suspected discogenic pain in the cervical, thoracic or lumbar spine.
3. Bring considered for discography in order to identify source of pain in the evaluation of potential surgical candidates.
4. History of neck pain or mid or low back pain for at least 3 months.
5. Failed to respond to conservative therapies that include physical therapy and analgesics.
6. Documented Pfirrmann grade changes of 7 or less at each treatment level as represented by an MRI no more than 12 months old (extravasation not excluded).

Exclusion criteria

1. Unresolved neck or back pain from a previous cervical, thoracic or lumbar surgery at any level.

2. Any contraindication for discography or surgery

3. Significant signs or symptoms of root or cord compression at treatment levels.

4. Any diagnosis of a concurrent pain disorder or other concurrent cause of disability.

5. Daily opioid requirements of greater than180 mg oral morphine equivalent

   (OME) per day.

6. Current active systemic infection, or history of disc infection.

7. Untreated disabling thought or mood disorder.

8. Inability to provide informed consent including subjects in a socially compromised condition such as prisoners.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

PRP/Hemocyte Autograft Intervention Arm

Experimental group

Description:

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.

Treatment:

Device: ProPlaz PPC

Device: High yield pure PRP

Placebo Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo