Platelet Rich Plasma injection to the lumbar facet joint for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Womack Army Medical Center, Fort Bragg, NC
+3 More
Platelet Rich Plasma injection to the lumbar facet joint - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a new treatment for back pain can help military personnel.

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Eligible Conditions

  • Low Back Pain
  • Back Pain
  • Arthralgia
  • Facet Joint Pain; Low Back Pain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Platelet Rich Plasma injection to the lumbar facet joint will improve 6 secondary outcomes in patients with Low Back Pain. Measurement will happen over the course of 6 months.

3 and 6 months
Defense Veteran Pain Rating Scale+ Supplemental Questions (DVPRS)
Global Rate of Change (GROC)
Oswestry Disability Index (ODI)
Patient Reported Outcomes Measurement Information System 29 and derived Pain Impact Scale(PROMIS-29)
Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LB)
6 months
Numeric Rating Scale (NRS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo injection to lumbar facet joint
Platelet Rich Plasma injection to lumbar facet joint
Placebo group

This trial requires 170 total participants across 2 different treatment groups

This trial involves 2 different treatments. Platelet Rich Plasma Injection To The Lumbar Facet Joint is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Platelet Rich Plasma injection to lumbar facet joint
Procedure
Platelet Rich Plasma injection to lumbar facet joint
Placebo injection to lumbar facet joint
Procedure
Placebo injection to lumbar facet joint

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 and 6 months for reporting.

Closest Location

Womack Army Medical Center - Fort Bragg, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Average daily numerical pain rating of at least 4 out of 10
DEERS eligible
Adult age 18-75 (inclusive)
Able to understand, read and speak English
Willing and able to provide written informed consent
Predominant area of pain is axial low back pain
Chronic low back pain lasting more than 3 months
Single positive diagnostic medial branch block (MBB) of greater than or equal to 50% reduction in symptoms after local anesthetic injection

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes back pain?

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This review gives a detailed outline of the current state of back pain for the practicing general practitioner and those investigating the condition from the medical literature.

Unverified Answer

Can back pain be cured?

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Findings from a recent study of this study suggest that the prevalence of chronic low back pain in the Icelandic population, as well as in some other societies, is not as high as previously reported, but chronic low back pain still remains a significant medical problem in the population, and can be regarded as a major public health problem, although it appears to be relatively under-recognized.

Unverified Answer

What are common treatments for back pain?

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People with back pain often seek multiple treatment types; therefore, the overall effect of treatment for people with back pain may be higher than reported. This may be important from the patient's perspective because a better quality of life can help boost motivation and self-efficacy to deal with chronic pain.

Unverified Answer

What are the signs of back pain?

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Back pain (painful, sharp, aching, dull) is a relatively common symptom for which patients seek medical attention. A patient should ask about the time course of the complaint and ask for an explanation of how the symptom began. The physical examination is important, and particular attention should be given to the back to look for a possible disc herniation, spinal stenosis, and degenerative disc disease. The pain may be a signal of underlying disease or may be indicative of other painful illnesses. If so, then a differential diagnosis should be made to exclude the possibility of back pain being caused by one of the many other diseases that cause unexplained pain.

Unverified Answer

How many people get back pain a year in the United States?

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In a national survey of people with back pain, the incidence of chronic back pain was 15% per year for men and 10% for women. The incidence of back pain per year increased with age both for men and for women at every age tested (p < 0.05). The incidence also was positively associated with the last 10 years' occupation in men for the last week worked and in women for the last year worked. This is of concern because back pain may interfere with employment. The incidence was lower in those not working. The survey found that the majority of men were doing some type of physical labor.

Unverified Answer

What is back pain?

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What is back pain? A large number of articles have stressed the importance of reporting back pain to a physician or other health professional. Although some articles are very detailed about the problem, others have been so vague that they give no clue to what really is wrong in the body. All the articles stressed that the goal of treatment and even the medical treatment of back pain is the same: to return to normal function and to return to normal health. If you have back pain, you must take care of your body. When you are sick, you must heal before going back to work.

Unverified Answer

Is platelet rich plasma injection to the lumbar facet joint safe for people?

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Findings from a recent study concludes that injection of PRP to the facet joint was not associated with an increase of new-onset back pain intensity or disability after a 4-month follow-up. However, we have to note that these conclusions are based on small numbers and that prospective randomized controlled trials with larger samples are warranted to confirm these results.

Unverified Answer

Is platelet rich plasma injection to the lumbar facet joint typically used in combination with any other treatments?

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In order to enhance the probability of success of this treatment, patients and caregivers must be informed correctly about the limitations, risks, and benefits of this treatment.

Unverified Answer

What is the latest research for back pain?

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There are few publications concerning back pain research, and most articles do not report or report insufficiently on key parameters such as study validity or relevance. For these and other reasons, the literature regarding back pain research is weak. Further research in medical ethics is required to allow the best use of human subjects; and it is prudent to avoid extrapolation between medical research and clinical practice in terms of the patient. The majority of available evidence does not support the benefits of surgery over other treatments, and most therapies can be expected to have a minimal effect (such as analgesia and the provision of anti-inflammatory medications). There is little evidence for the validity or validity of alternative medicine interventions.

Unverified Answer

Has platelet rich plasma injection to the lumbar facet joint proven to be more effective than a placebo?

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Results from a recent clinical trial shows that PRP injection into the lumbar facet joint does not have any positive effect in this study with degenerative disc disease. There seem to be a need for longer follow ups to see if there are any other effects of repeated PRP injections.

Unverified Answer

Have there been other clinical trials involving platelet rich plasma injection to the lumbar facet joint?

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There have not been any trials which suggest that PRP is an effective treatment for facet joint disease. However, it has been widely accepted as an effective treatment of subacute and acute cervical, thoracic and lumbar spine fusion. PRP may act as an aid to bone healing by means of autologous cell recruitment into debridement wounds and bone grafts. However, there are no human trials or case report studies which demonstrate any clinical benefit of PRP over bone graft, regardless of the type of fusion proceeding.

Unverified Answer

How does platelet rich plasma injection to the lumbar facet joint work?

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PRP injection of the facet joint shows limited and inconsistent benefits in a large sample with sub-therapeutic dosage. It is not an effective treatment for long-standing sub-acute to chronic facet joint pain. A further large, placebo-controlled randomized trial is warranted to validate the results and evaluate additional therapies for facet joint pain.

Unverified Answer
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