Prolotherapy treatments for lumbar instability and low back pain

Ross Hauser, MD

In December 2021, we published our peer review paper Lumbar instability as an etiology of low back pain and its treatment by prolotherapy: A review in the Journal of Back and Musculoskeletal Rehabilitation. (1) Here we present a lay version with explanatory notes. The link below will take you to the full paper as published.

What makes the spine stable? What makes the spine unstable with instability?

The spine is held together and made stable from the intervertebral discs and the surrounding ligaments and muscles, with the discs and ligaments providing the spine with its natural function and stability, and the muscles, extrinsic (outer) support. In the lumbar spine, there are usually 5 vertebrae (L1–L5); rarely. The lower back is formed by the lumbar spine and the beginning of the sacral spine (S1), which is why it is important to examine the sacroiliac joints when a patient complains of persistent low back pain.

The Denis model (a means to help classify injury to the spine) divides the spine into 3 columns.

The anterior longitudinal ligament

The posterior longitudinal ligament

The ligamentum flavum, and the interconnecting ligaments of the posterior spine

How much column injury is considered enough to cause spinal instability?

What are we seeing in this image? The columns of the spine and the areas where spinal instability may occur.

At the front of the spine facing forward are:

At the back of the spinal column, we see the components of the third column of the Denis spinal injury model with a focus on the interconnecting ligaments of the posterior elements.

What are we seeing in this image? The columns of the spine and the areas where spinal instability may occur.

Degenerative disc disease or chronic back problems typically do not begin immediately after a traumatic injury but instead begin to develop once ligaments start to creep (tendency to slowly elongate and become loose and lax) after prolonged stretching. (The ligaments are like rubber bands. Over time the rubber band through continuous hyper stretching becomes stretched out. This creeping behavior is the result of the forward motions engrained in the human lifestyle. Our days are spent in physically demanding activities or in sedentary postures that can lead to gradual loosening of the posterior ligamentous complex (PLC) over time.

What then are the overriding effects of a gradual loosening of the ligaments in the lower back?

Our bodies are remarkably intuitive in sensing when something has gone awry, especially when it concerns a vital structure like the spine, and respond by adopting other measures to maintain the spine’s stability.

When the cause of low back pain is misdiagnosed or not identified – inappropriate treatment follows

When the cause of the person’s low back pain is unknown, or a person is given an inaccurate diagnosis, unnecessary spinal surgeries or other invasive procedures are more likely to occur, (please see my articles Can you realistically avoid lumbar surgery for bulging or herniated disc?Is your MRI or CT Scan sending you to a back surgery you do not need?) and the overuse of opioids and imaging will continue to be a widespread problem. Diagnosing a person’s low back pain can be difficult to determine since the lumbar spine, like the body itself, consists of many components capable of generating pain and does so via a set of complex pain patterns.

Although many treatments and interventions have been explored for disc degeneration, all have had drawbacks. Treatment options such as pain medications, steroid injections, discectomies, and spinal fusion surgeries only address symptoms but do little to stop the degeneration process. Regenerative medicine, including cellular therapies, focuses instead on the biological repair or regeneration of the disc and surrounding facet joints, posterior ligaments, etc. This has many advantages over current therapies and regenerative treatments that are coming of age in the treatment of discogenic back pain. These therapies include non-cellular and cellular prolotherapy (mesenchymal stem cells or bone marrow aspirate, PRP (please see my article Platelet Rich Plasma Therapy and lower back pain) and offer the most promise, as they have the potential to provide meaningful pain relief and functional restoration to the spinal ligaments and discs.

Prolotherapy injections

The main theme of this article is treating low back pain with Prolotherapy. So let’s begin with an explanation of Prolotherapy.

Prolotherapy is a regenerative injection treatment that uses various injectable biological substances to initiate an inflammatory healing cascade, mimicking the body’s own response to repairing musculoskeletal injuries.

Prolotherapy treatments are broadly divided into three types of injectables

While these different methods of Prolotherapy can be used to treat lumbar instability and its consequent pain syndromes, the administered treatment should be tailored to each individual patient, depending upon confirmation of their diagnosis and primary pain generator. Pain sources include the lumbar facet joints and their capsular ligaments, over-pressured or deranged intervertebral discs resulting from lumbar instability, and sacroiliac and iliolumbar ligaments.


Targeting the facet joints of the spine

In the illustration below we see normal capsular ligaments at the facet joint, the joint between two vertebrae. When the capsular ligaments at the facet joint are injured, stretched, or loose, the integrity of the spinal column is compromised and the vertebrae start wandering around. This results in the flattening of the disc and a diagnosis of degenerative disc disease. This is demonstrated in the bottom half of the illustration where we see the damage to the capsular ligaments resulting in hypermobility of the facet joint or gapping fact joint that is now flattening the disc.

The lumbar facet capsular ligament is always under tension and likely always being stretched.

In June 2022 (19) researchers at the Department of Biomedical Engineering, University of Minnesota offered an examination and assessment of the lumbar facet capsular ligament. They write: “(the lumbar facet capsular ligament) which surrounds and limits the motion of each facet joint in the lumbar spine, has been recognized as being mechanically significant and has been the subject of multiple mechanical characterization studies in the past. Those studies, however, were performed on isolated tissue samples and thus could not assess the mechanical state of the ligament in vivo. . . )” In other words, understanding the lumbar facet capsular ligament was based on small tissue samples studied in a laboratory. In this study the researchers performed cadaveric studies to show  increases in pressure and strain. What they found, based on testing the ligaments and on the work of previous studies was  that the lumbar facet capsular ligaments, is in tension, and that the collagen in the ligament is likely uncrimped (stretched) even when the spine is not loaded.”

The lumbar spine is considered unstable if abnormal strains or excessive motion develop in the functional spinal unit

The facet joints are considered crucial stabilizers of the spine because they play an important role in load transmission, acting as the posterior load-bearing component for stabilizing the motion segment in flexion (bending forward) and extension (bending backward) while restricting axial rotation (turning to the side). Together with the intervertebral disc, the facet joints transfer loads and guide and constrain motions in the spine.

The lumbar spine is considered unstable if abnormal strains or excessive motion develop in the functional spinal unit, a structure that contains the bodies of the upper and lower vertebrae and the disc between them, as well as the facet joints, which join the vertebrae together. The functional spinal unit is surrounded by ligaments, including the posterior ligament complex (the ligaments demonstrated in the illustration above) which are crucial for maintaining spinal stability. This includes the posterior longitudinal ligament, supraspinous ligament, interspinous ligament, ligamentum flavum, and facet capsule ligaments. The roles of the posterior ligament complex are to limit excess motion and resist bending and compressive forces. This second function is particularly important, as demonstrated in a study that found intradiscal pressure increases greatly during sitting, lifting, or forward-leaning, alone or with twisting, the latter of which involves shear forces that the posterior ligament complex is ill-equipped to handle. All these motions were found to trigger the loading of such forces onto the posterior ligament complex [2,3].

The facet joints are where the bones of the spine meet and connect to form the spinal column. Functionally, they are the joints that allow the spine to bend and twist. They also hold the spine in place so you do not “bend over backward.” The nerves of the spinal cord pass through these joints. If the fact joint is compromised or in a state of degenerative disc disease, the familiar numbness and pain extending into the arms and legs can be seen.

For our companion article please see Facet Joint Osteoarthritis and Facet Arthropathy Treatments.

What are we seeing in this image?

The facet joint is at the rear of the vertebrae. The small arrows pointing away from each other in the first image and the small arrows pointing towards each other in the second image are at the point of the facet joints. What is that spring in the back? The spring represents forces.

Spinal force transmission, some people call strain on the back, is represented by the various motions of the spine. A flexion, bending forward causes the posterior or back portion of the disc to bulge outwards and the facet joint and the “tail” or protrusion of the vertebrae, the spinous process, to pull away from each other. The opposite happens with extension, bending backward. The same forces apply to banding to the side at the waist.

Spinal force transmission, some people call it strain on the back, are represented with the various motions of the spine. A flexion, bending forward causes the posterior or back portion of the disc to bulge outwards and the fact joint and the "tail" or protrusion of the vertebrae, the spinous process, to pull away from each other. The opposite happens with extension, bending backwards. The same forces apply to banding to the side at the waist.

When the ligaments of the posterior ligament complex – you bend too far and that is painful

Should the posterior ligament complex become injured or unable to resist those forces, the lumbar disc would become a pain generator. Other important ligaments surrounding the functional spinal unit are the intertransverse ligament, the anterior longitudinal ligament, and the posterior longitudinal ligament.

Studies have evaluated the effects when various ligaments of the posterior ligament complex become dysfunctional. For instance, the removal of the facet joint capsular ligaments in the lower lumbar spine causes a large increase in pressure within an otherwise healthy lumbar disc, which we discussed above and demonstrated in the illustration, damage to the ligaments cause the disc to bulge, and cutting these ligaments in the upper lumbar spine causes an increase in a side-to-side bending motion, simply you bend too far.

What are we seeing in this image?

While the lumbar disc and the facet joints are both common pain generators, the facet joint capsular ligaments are arguably the most critical starting point in the development of lower back disorders. This is so because their injury would result in increases in shear forces (side-to-side motion), thereby increasing the likelihood that instability would occur, along with subsequent facet joints and lumbar disc degeneration. It should be noted that the facet joints and interspinous ligaments are the first to be injured under degenerative conditions.

While the lumbar disc and the facet joints are both common pain generators, the facet joint capsular ligaments are arguably the most critical starting point in the development of lower back disorders. This is so because their injury would result in increases in shear forces (side-to-side motion), thereby increasing the likelihood that instability would occur, along with subsequent facet joints and lumbar disc degeneration. It should be noted that the facet joints and interspinous ligaments are the first to be injured under degenerative conditions

Prolotherapy to target this problem – research is limited

Although facet joint pain can account for up to 45% of low back pain, there are few randomized controlled studies in the literature on the use of comprehensive or cellular prolotherapy for treating this type of pain. Narrative review studies (where the authors interpret previously published medical works) and systemic reviews (where the authors combine data and empirical evidence from previously published medical works), as well as meta-analysis (authors rely on data outcomes), noted overall positive results especially with cellular (PRP and/or Mesenchymal stem cells prolotherapy but mixed with dextrose prolotherapy for chronic low back pain [4, 5]. Currently, standard medical care remains focused on masking facet joint pain instead of diagnosing and treating the real cause, which is joint instability. Historically, treatment options have included oral NSAIDs and physical therapy, as well as more invasive interventions such as facet joint corticosteroid injections, diagnostic nerve blocks to the facet joints, and radiofrequency ablation of the sensory nerves supplying the joints if the diagnostic block is positive.

What are we seeing in this image?

Normal enthesis vs. enthesopathy from joint instability and aging. The entheses organ (the whole soft tissue) is the place where ligaments attach to bone. Increased forces (abnormal stress as in conditions of instability and spine or joint) on the entheses cause them to thicken and with continued joint forces, entheses inflammation, causing a lot of pain.

What we see in this image is:

  1. Normal attachments of sot-tissue to the bone, normal enthesis.
  2. Age-related thickened enthesis. The thickening or scarring of the enthesis occurs because of chronic inflammation in the area.
  3. This progresses to long-standing joint instability with inflamed enthesis and diffuse bone edema.
  4. This progresses to enthesopathy, the diagnosis of inflammation and degenerative disease in the spine.
  5. Eventually, degenerative spine or disc disease develops into arthritis, the development of bone spurs along the spine, and a flattening of the disc as outlined above.

Normal enthesis vs. enthesopathy from joint instability and aging.

Prolotherapy and PRP for facet joint pain

A single-blind, randomized, crossover study evaluated the effectiveness of injection therapy in 35 patients diagnosed as having painful enthesopathy (these are painful conditions caused by the ligament or tendon attachment to the bone). (6)

In this study, 86% of patients had prior spinal surgery and continued pain.

Outcomes following prolotherapy treatment

Sustained pain reduction has been demonstrated in a prospective consecutive patient series in which the effects of disc space injections of hypertonic dextrose were assessed in patients with chronic advanced degenerative discogenic leg pain, with or without low back pain, including those with moderate to severe disc degeneration and concordant pain reproduction with CT discography. In this 2006 study published in the journal Pain Medicine (7) patients underwent bi-weekly disc space injections of a solution consisting of 50% dextrose and 0.25% bupivacaine in the affected disc(s). Each patient was injected an average of 3.5 times. Overall, 43.4% of patients achieved sustained improvement as shown by average changes in numeric pain scores of 71% between pretreatment and 18-month measurements. The authors concluded that intradiscal injection of hypertonic dextrose has promise as a treatment for managing the pain of advanced lumbar disc degeneration.

In a retrospective case series of 21 patients with MRI-confirmed lumbar disc degeneration and refractory low back pain/non-radicular low back pain, 18 (86%) of patients experienced 70% or greater improvements in pain and function (8) at 1-year follow up. Patients underwent 3 Prolotherapy treatment sessions at 1–3 weeks apart, which included injections at the ligamento-periosteal junctions at the origin and insertion of the posterior sacroiliac ligaments, iliolumbar ligaments, facet joint capsules, and supraspinous and interspinous ligaments (all bilaterally). Injections were done under fluoroscopic guidance.

A small case series of 4 patients (9) with low back pain also proved successful in treating those with disc herniations with Prolotherapy. Patients underwent 3–9 Prolotherapy sessions to the ligaments of the low back (almost all 1 month apart) with all patients experiencing 95–100% pain relief and increase in function, including the ability to return to work.

Sacroiliac joint-mediated pain

Published in the British Journal of Sports Medicine, doctors found positive clinical outcomes for 76% of patients with sacroiliac joint problems. (10) This study was conducted to determine whether Prolotherapy is effective in the treatment of deficient load transfer of the sacroiliac joint in 25 patients. In this study, 3 injections at 6-week intervals of a hypertonic dextrose solution were given into the dorsal interosseous ligament of the affected sacroiliac joint of each patient. Outcome measures standard test scoring to determine pain and function as well as an independent clinical examination by the paper’s two authors. The authors concluded that their descriptive study of Prolotherapy in private practice showed positive clinical outcomes for the 76% of patients who attended the 3-month follow-up visit (76% at 12 months and 32% at 24 months).

A 2010 paper published in the Journal of alternative and complementary medicine (11) compared the pain relief effects of Prolotherapy to corticosteroid injection. At 15 months, 58% of the patients treated with Prolotherapy reported that more than half of their pain was relieved, which was statistically significant compared with only 10% in the corticosteroid group who reported that same level of pain relief. The researchers here concluded: “Intra-articular Prolotherapy provided significant relief of sacroiliac joint pain, and its effects lasted longer than those of steroid injections. Further studies are needed to confirm the safety of the procedure and to validate an appropriate injection protocol.”

An earlier study in the Journal of Spine Disorders (12) demonstrated that for patients with chronic low back pain who had failed to respond to previous conservative care that Prolotherapy could be an effective treatment. Patients were randomly assigned to receive a double-blind series of 6 injections at weekly intervals of either a xylocaine/proliferant or a xylocaine/saline solution into the posterior sacroiliac and interspinous ligaments, fascia, and joint capsules of the lower back from L4 to the sacrum. Of the 39 patients assigned to the proliferant group, 30 achieved a 50% or greater reduction in both pain and disability scores at 6 months compared with 21 of 40 in the group receiving the saline solution. The proliferant group also achieved greater improvements on the visual analog, pain, and disability scales.

In a 2004 (13) audit of conservative treatments for low back pain, patients who were diagnosed with sacroiliac pain via diagnostic block were treated either by corticosteroid injection to the sacroiliac joint or by Prolotherapy to the sacroiliac ligaments. Long-term improvement was assessed at 6 months, after which 63% of the Prolotherapy group reported a substantial drop in pain severity compared with only 33% in the corticosteroid group.

PRP injections

A study (14) into the use of PRP for facet joint pain examined the results of guided injections of PRP into the lumbar facet joints of 19 patients. The study found that PRP had beneficial effects which improved over time, with 15 of the 19 patients experiencing significant pain reduction by 3 months.

In a subsequent randomized prospective study with a larger cohort of 46 subjects, the same lead author (15) compared the results of facet joint injections using either PRP or anesthetic and corticosteroid. At the 1-month mark, 80% of subjects in the corticosteroid group were satisfied with the results of the procedure, but this declined to between 20% and 50% after 6 months. Conversely, the subjects in the PRP group had an increase in satisfaction over time, leading the authors to conclude that PRP was the superior treatment. As the facet joint capsular ligaments loosen, the spinal segments begin to flex (bend forward) more, though imperceptibly to us, when a person leans forward, sits, or lifts. Over time, this results in several possible adaptations, the first of which is disc degeneration.

The use of PRP for treating musculoskeletal conditions is growing, and studies specific to sacroiliac mediated pain have found that PRP provides favorable outcomes. In one randomized, controlled trial of PRP versus corticosteroid injection, 90% of subjects treated with PRP to the sacroiliac joint were satisfied at the 3-month follow-up compared with only 25% of those who were treated with the steroid. The researchers concluded “Despite the widespread use of steroids to treat sacroiliac joint pain, their duration of pain reduction is short. Platelet-Rich Plasma (PRP) can potentially enhance tissue healing and may have a longer-lasting effect on pain.”(16).

What are we seeing in this image?

The progression of degeneration in the lower back starts with an initial injury to one or more spinal ligaments. Over time, the process progresses to involve more spinal segments. Eventually, unresolved spinal instability can cause multi-level degeneration of the lumbar spine.

The progression of degeneration in the lower back starts with an initial injury to one or more spinal ligaments. Over time, the process progresses to involve more spinal segments. Eventually, unresolved spinal instability can cause multi-level degeneration of the lumbar spine.

Degenerated discs produce a pain that is typically resistant to steroids, intra-discal electrothermoplasty, (or IDET used to treat lumbar discogenic pain, and direct surgical intervention, while also being difficult to resolve. However, exposure of irritated nerves to hypertonic dextrose prolotherapy is thought to have chemoneuromodulatory (in simplest terms works as an anti-inflammatory in nerve-related pain) potential.

Sustained pain reduction has been demonstrated in a prospective consecutive patient series in which the effects of disc space injections of hypertonic dextrose were assessed in patients with chronic advanced degenerative disc-related leg pain, with or without low back pain, including those with moderate to severe disc degeneration and concordant pain reproduction with CT discography. In this study from 2006 cited above (7), patients underwent bi-weekly disc space injections of a solution consisting of 50% dextrose and 0.25% bupivacaine in the affected disc(s). Each patient was injected an average of 3.5 times. Overall, 43.4% of patients achieved sustained improvement as shown by average changes in numeric pain scores of 71% between pretreatment and 18-month measurements. The authors concluded that intradiscal injection of hypertonic dextrose has promise as a treatment for managing the pain of advanced lumbar disc degeneration.

In an editorial, a board-certified physician in family medicine whose specialty is pain management made several points about the treatment of low back pain with Prolotherapy (17).

Conclusions and new research

In this section, we will present updated research and our conclusions.

A December 2021 paper in the Journal of Back and Musculoskeletal Rehabilitation (18) comes to us from the University of Health Sciences in Ankara, Turkey. These are the learning points of this research.

Six hundred fifty-four patients were included in the study. Diagnostic injections were performed on all patients who were thought to be eligible candidates for Prolotherapy indications. A 4-or-6 week interval was allowed between treatment sessions.

1954 patient treatments were completed.

The Visual Analogue Scale (0-10 0 = no pain 10 = severe, unbearable pain) scores decreased from very severe pain of 7.2  to a mild to almost no pain score of 0.9 after 52 weeks of the treatment.

Thirty-four patients’ treatments resulted in poor clinical results (5.2%), and 620 of the patients’ pain improved (94.8%).

Conclusion: “Prolotherapy can be regarded as a safe way of providing a meaningful improvement in pain and musculoskeletal function compared to the initial status. The diagnostic injection is an easy way to eliminate patients and may become a favorite treatment modality. 5% dextrose is a more simple and painless solution for Prolotherapy and also has a high success.”

Note: One aspect of this research was the use of numbing agents as a diagnostic tool to pre-assess if Prolotherapy would be effective. It should be noted that while Prolotherapy treatments reduced the Visual Analogue Scale from 7.2 severe pain to mild to almost no pain on average in 94.8% of patients, numbing agents injected only reduced pain in the same group from 7.2 severe pain to 5.1 or a grade of moderate to severe pain.

Another aspect was the amount of dextrose given in the injection. Prolotherapy injections can come in varying amounts of dextrose concentration. Here a more modest 5% dextrose solution was used to great effect. The concentration of dextrose in Prolotherapy injections can range from 5% to 25%, we prefer the lower ranges.

Summary

In summary, Prolotherapy can be an effective treatment for chronic back pain due to spinal instability. Some telltale signs that you have spinal instability include chronic muscle spasms, pain that shoots down the legs intermittently, your spine cracks and pops, and you feel the need to manipulate your spine or receive frequent adjustments and massages.

The true source of pain is due to ligament weakness. The causes can be many, such as traumatic or over time due to poor posture or overuse. Either way, it is a ligament problem. Prolotherapy strengthens ligaments and eliminates chronic back pain in conditions such as degenerated discs, herniated discs, spondylolisthesis, post-surgery pain syndromes, arachnoiditis, and scoliosis. The most common cause of chronic low back pain and “sciatica” is the laxity of the sacroiliac ligaments. For many people, Prolotherapy should be considered before any surgical procedure is performed for chronic back pain.

Given the widespread prevalence of spinal disorders, clinicians should understand ligaments as a causative factor for lumbar spinal instability resulting in chronic and worsening low back pain. Degenerative spine conditions are initiated by the development of instability within the posterior ligament complex, most notably the facet joint capsular ligaments. In response, the body makes adaptations trying to stabilize the spine, which is initially protective but eventually becomes harmful (e.g., bone spurs). Without addressing the instability, the progression of degenerative spinal conditions with low back pain will continue.

Clinically speaking, spinal stability is the ability of the spine to maintain its alignment during loading and to protect the neural structures it encloses without causing pain. It is the collective job of the bones, muscles, discs, and ligaments to maintain their alignment of the spinal column, so the spinal cord and nerves remain protected. If the spine no longer has properly functioning biomechanical properties, however, clinical stability is lost, giving rise to spinal instability and pain. Prolotherapy is a regenerative treatment option for those suffering from low back pain and associated conditions related to joint and spinal instability. Regenerative treatment to injured ligaments has the potential and ability to strengthen the posterior ligament complex, and thus relieve both chronic and acute low back pain.

Questions about our treatments?

If you have questions about your pain and how we may be able to help you, please contact us and get help and information from our Caring Medical staff.

This is a picture of Ross Hauser, MD, Danielle Steilen-Matias, PA-C, Brian Hutcheson, DC. They treat people with non-surgical regenerative medicine injections. Offices are located in Oak Park, Illinois and Fort Myers, Florida.

Brian Hutcheson, DC | Ross Hauser, MD | Danielle Steilen-Matias, PA-C

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References

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This article was updated May 24, 2022

 

 

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