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Journal of
Prolotherapy. 2009;1:22-28.
REMARKABLE RECOVERIES
Standard Clinical X-ray Studies Document
Cartilage Regeneration in Five Degenerated Knees After Prolotherapy
Ross
A. Hauser, MD & Jseph J. Cukla, LPN
Abstract
Degenerative Joint Disease is the most common form of
arthritis.
The condition is marked by progressive destruction of the articular
cartilage which is easily documented by standard X-ray studies. The
regeneration of this articular cartilage in clinical practice has been
difficult. Five knees with articular cartilage degeneration were treated
with Prolotherapy in this report. Each of the five knees showed
improvement of their standard clinical X-rays after the Prolotherapy,
signifying articular cartilage repair with Prolotherapy. It is suggested
that before and after X-ray studies can be used to document the response
of degenerated joints to Prolotherapy.
introduction
Osteoarthritis
(OA) is one of the major problems affecting our aging
population. It has been estimated that two to three percent of the adult
American population suffers from regular pain from OA, and approximately
one-third of adults in the US between the ages of 25-74 have
radiological evidence of OA in at least one of the major joints.1
Autopsy specimens have demonstrated a 90% prevalence of articular
cartilage degenerative changes in weight bearing joints in individuals
older than 40 years old.2 The knee is
the most symptomatic joint affecting 6.1% of all adults over the age of
30 but rising to 16% of adults over the age of 45.3,4,5
Because there is no currently accepted method to stop or reverse joint
degeneration, the incidence of symptomatic OA increases by about 1% each
year.6
Osteoarthritis is the most common form of knee arthritis and can involve
any or all three compartments in the knee: the medial compartment
(medial tibial plateau and medial femoral condyle); the lateral
compartment (lateral tibial plateau and lateral femoral condyle); or the
patellofemoral compartment (patella and femoral trochlear notch).
The increasing number of joint complaints and radiological OA is matched
by the rising number of major joint replacements. In one state alone the
total number of total
knee replacements
increased by 81.5% from 1990 to
2000, with a subsequent rise in costs for these procedures of over 200%.7
It is estimated that in the US, the total number of joint replacement
surgeries of the hip and knee will increase from 684,000 cases in 2003
to over a million by 2013.8
The current conservative treatments for OA including medications,
exercise,
Physical therapy, corticosteroid injections, weight control,
Synvisc and Hyalgan injections, and operative treatments including
arthroscopic often leave people with residual pain.9-12 Because of this, many people with OA are seeking
alternative treatments including Prolotherapy.13-14
Prolotherapy, also known as regenerative injection therapy, involves the
injection of substances into degenerated or injured areas to stimulate
healing.15-17 While it has been
traditionally used for ligament and tendon injuries, it has a long
history of use in OA.18-20 Two
placebo-controlled double-blind studies by K. Dean Reeves and associates
have demonstrated beneficial effects of Prolotherapy on OA including
some X-ray changes.21-22
This report documents the results in
five degenerated knees treated with Prolotherapy. Before and after
X-rays were available to document articular cartilage regeneration with
Prolotherapy.
METHODS
Three patients representing five degenerated knees underwent
Prolotherapy at the private practice of the primary author at Caring
Medical and Rehabilitation Services in Oak Park, Illinois. Each patient
underwent standard
Hackett-Hemwall Prolotherapy to the knee.23
Each patient had the following areas injected: intraarticular, pes
anserine, medial collateral and lateral collateral ligament attachments,
and medial side of the patella. The basic solution used was 15% dextrose
and 10% Sarapin. Each joint received 2IU of Human Growth Hormone by
injection. A total of 5 to 10cc of Prolotherapy solution was injected
into the joint at each visit. Four hundred milligrams of glucosamine
sulfate was added to one of the 10cc syringes. A total of 30 to 40cc of
Prolotherapy solution was used per knee at each visit. This represented
20 to 30 injections per knee per visit.
CASE DESCRIPTIONS
Case One: CW is a 72 year-old woman who
presented in July 2004, complaining of a five-year history of severe
right knee pain. She rated her knee pain on the visual analogue scale
(VAS) at a level of 6 on a scale of 0 to 10. She experienced daily pain
throughout the whole knee and noted that the severity of the pain was
also increasing. Her other symptoms were increased pain upon sitting for
long periods of time, difficulty with stairs, and increased pain with
walking. She was not exercising. She had no previous history of trauma
or
knee surgery. Three previous hyaluronic acid treatments provided
diminishing relief. She used the oral pain relievers, tramadol
hydrochloride and acetaminophen, as needed. X-rays done in 2002 showed
osteoarthritis, marked loss of joint space medially, subchondral
sclerosis and osteophyte formation. CW was told by an
orthopedic that
she needed a total knee replacement. She read about Prolotherapy in an
alternative medicine newsletter and wanted to try it instead of surgery.
Physical examination showed normal knee alignment. Lachman, anterior
drawer, valgus and varus stress tests were all negative. She exhibited
joint line tenderness both medially and laterally, but worse medially,
as well as quite a bit of crepitus in the knee throughout the range of
motion. There was no swelling present in the knee. Her range of motion
was 3 to 95 degrees.
Prolotherapy treatments began in July 2004. CW received nine treatments
on her right knee through May 2005. She reported an incremental decrease
in pain and increased mobility as she was interviewed every four to six
weeks during the course of treatment. Her range of motion had improved
to full extension and flexion to 110 degrees. Her crepitus was nearly
nonexistent. She reported at this time, “I am 97% better. I have no pain
(VAS score 0), just mild stiffness that subsides with walking.” She was
treated one more time and told to return to the clinic if the pain
returned. She no longer needed medications or a total knee replacement.
CW returned to the clinic in May 2006 because she twisted her knee and
some of her pain returned. Her physical exam at that time was unchanged
from when she was seen in May 2005, except she showed more medial joint
line tenderness and tenderness at the pes anserine area. She received
four more treatments over the next four months, making incremental
improvements in her pain. At this time, the patient was doing great, yet
desired to see “how my cartilage was doing.” The X-rays showed a large
increase of medial joint space. (See Figure 1.) By this time,
the patient had received 14 Prolotherapy treatments to her knee.
Seventeen months after her last Prolotherapy treatment, the patient
continues to have full function of the knee with almost no pain (0 to 1
on VAS). She has returned to full activities without pain and is on no
pain medications.
Figure 1. Standard weight
bearing knee X-rays of C.W. before and after Prolotherapy. The
widening of the medial joint space width indicates that cartilage
regeneration has taken place.
Case Two: JP is a 60
year-old female who was first seen in October 2005 complaining of a
three year history of bilateral knee pain. She rated her right knee pain
as 6 and her left knee as a 5 on the VAS. The pain in both knees
occurred primarily in the medial area. Rising from a chair, taking the
stairs, and simply walking caused pain. The patient tried using heat,
ice, aspirin and ibuprofen to alleviate the pain. She tried to avoid
allowing the pain to limit her activities, but she was now down to
walking once or twice a week instead of daily. She could only stand for
short periods of time now. She also noted that getting up from a low
couch or stool was now “very difficult.” She felt the strength in her
legs was rapidly diminishing. X-rays done in April 2005 by her primary
care physician showed moderately severe osteoarthritic degenerative
changes bilaterally, greatest in the medial compartments. She told her
massage therapist about the X-ray and she recommended a Prolotherapy
evaluation.
Physical examination revealed full extension, but only 90 degrees of
flexion. Tenderness with palpation at the medial joint line bilaterally
was also noted. The patient was unsteady with a one-legged stand on
either leg. Moderate clicking was noted in both knees. There was no
evidence of swelling or joint instability.
JP steadily improved with Prolotherapy treatments. When seen in
September 2006, after eight Prolotherapy treatments on her right knee
and six on her left, she reported an 85% reduction in pain in the right
knee and 70% in the left. She now had some pain free days. She noticed
the clicking in both knees was markedly less and was now able to climb
stairs without any complaints. Her walking was uninhibited as long as it
was slow without much pain. She felt she had poor balance if she walked
fast. JP did great, but felt some stiffness with long periods of
sitting, thus she came in for one more visit in May 2007. This was her
eleventh Prolotherapy on her right knee and ninth on her left knee. Her
walking was now completely pain free. Physical examination at that time
showed that her bilateral knee flexion had increased to 100 degrees and
the clicking had completely resolved. She requested repeat X-rays after
that visit and they showed a significant improvement of the joint space
width in both knees both medially and laterally. (See Figure 2.)
Specifically the X-rays on both knees showed a joint space now present
medially.
When phoned six months after her last visit in 2007, she noted that both
knee joints were gliding smoothly and were “not making any noises”
according to the patient. She had no pain with walking or stairs. She
was on no pain medications and felt she had absolutely no limitations in
regard to her knees.
Case Three: JL is a 42
year-old female who came in with a ten year history of bilateral knee
subluxations and diffuse knee pains. Her goal was to decrease pain with
the hope of being able to play competitive tennis again. She complained
of her knees “giving out,” along with having bilateral medial knee
weakness, joint stiffness, and recurring edema with most leg exercises.
The patient reported that the pain was making tennis playing impossible.
She was being followed by an orthopedic physician because of her severe
bilateral chondromalacia. He prescribed piroxicam 20mg daily and ordered
her to discontinue tennis and lower extremity weight training for a
minimum of eight weeks. He also ordered 10 weeks of physical therapy,
which was of no help to the patient in reducing her pain. She rated her
pain as a seven on the left knee and six on the right knee (VAS) 0 to
10. Physical exam revealed significant crepitation in knees bilaterally.
The patellas were tracking laterally with excessive movement. Lachman,
anterior drawer, valgus and varus stress tests were all negative. She
had full knee extension, but flexion was limited to 90 degrees
bilaterally. She found out about Prolotherapy through an internet
search.
The knees were treated with Prolotherapy on her first visit in October,
2006 and she returned for treatment every four to six weeks. As she felt
better, she began to increase her tennis and exercise levels with slight
discomfort coming only after competitive tennis, especially playing
consecutive days. She reported after the seventh visit that she was
having no recurrences of her knees “giving out” and her knee pain was
improved 80%. She rated it a 3 bilaterally on VAS. After the ninth
visit, she reported a 90% improvement in knee strength, and a 75%
improvement in crepitus. She noted some pain-free days. On physical
examination she had almost no clicking in the knee. JL received a total
of 11 Prolotherapy treatments when seen in September 2007. Her patellar
gliding was normal with normal patellar tracking. Her range of motion
was now full. At this time her chiropractor ordered X-rays of her knees.
Comparison X-rays of September 2006 versus September 2007 showed a
significant increase in joint space in the lateral compartments, with
improvement of patellar alignment. (See Figure 3.)
While JL made tremendous strides with Prolotherapy, unfortunately in the
spring of 2008, because of her tremendous training schedule, to make an
elite traveling tennis team, she developed new injuries and had to give
up her spot on the team.
DISCUSSION
A series of Prolotherapy treatments improved the X-ray findings in these
five degenerated knees. Specifically, the joint space width (JSW) in
these X-rays increased with Prolotherapy, signifying the regeneration of
articular cartilage. The three patients also reported improvements in
their pain and function with the Prolotherapy treatments.
Articular cartilage degeneration is the hallmark of the osteoarthritis
that affects 46 million Americans. It has a major impact on functioning
and independence and is the leading cause of disability in the general
population of the United States according to the Center for Disease
Control (CDC).24 As the U.S.
population ages, these numbers are likely to increase sharply. Among
adults of working age (18 to 64 years), work limitations attributable to
arthritis affects about one in 20 adults in the general population and
one-third of those with arthritis.25
For example, the annual cost of OA per person living with OA is
approximately $5,700, but the economic burden of disabling knee and
hip osteoarthritis has an annual cost per person of almost $10,000.26-27
Needless to say efforts or treatments that could potentially reverse or
stop the progression of OA would have a huge quality of life, as well as
economic impact not only on individual patients but on health care costs
overall.
Radiography is currently the most widely used method to assess damage in
osteoarthritis, and regulatory requirements for the development of
disease-modifying drugs in osteoarthritis still consider the measurement
of joint space narrowing on plain X-rays to be the appropriate primary
endpoint for demonstration of efficacy.28-30
The radiographic grade of osteoarthritis has been shown to correlate
with the amount of actual articular cartilage degeneration in the knee
with chronic pain.31 Standardized
techniques for measuring joint space width (JSW) in the tibiofemoral
compartments, taken from carefully acquired radiographs, have become
accepted for quantifying changes in tibiofemoral hyaline articular
cartilage thickness in knee osteoarthritis.32-33
JSW measurement is used in the diagnosis of OA.34
(See Figure 4.)
Absolute values for what is normal JSW is impossible because cartilage
thickness varies so much from person to person.35
Its use though is invaluable when monitoring the normal progression of
OA and would be following the regression of OA with Prolotherapy.36
According to the American Association of Orthopedic Surgeons from a
clinical perspective, the most compelling definition of knee OA is one
that combines the pathology of osteoarthritis through confirming
radiographs with patient reported symptoms of pain that occurs with
joint use.37 When evaluating patients
with osteoarthritis of the knee, anterior/posterior, and lateral
radiographs allow an adequate evaluation of the medial and lateral joint
spaces.38 To adequately assess the
joint space, the anterior/ posterior view should be obtained with the
patient in a standing position.39 The
lateral view also allows evaluation of the patellofemoral joint;
however, an additional view, known as the sunrise view, can offer, even
more information about this joint space (this is also called the
merchant or sunrise view).40 To ensure
that the pre and post-Prolotherapy X-rays could be compared in regard to
angle of the X-ray, a board certified radiologist reviewed all the
films.41
X-rays were obtained in these five knees upon the request of the
patients. It is not routine to order X-rays on patients with positive or
curative results. These five knees suggest that standard clinical
radiographs of the knee may prove beneficial in confirming the reason
for the patients’ improvement with Prolotherapy.
Cases one and two represent the most
common form of knee OA, degeneration of the medial femorotibial joint.
The improvement of the JSW in case one was 0.5mm. In case two, the right
knee JSW increased by 0.4mm and the left by 0.3mm. Case three involved
the regeneration of the patellofemoral joint. This person had
chondromalacia patella. Not only was there evidence of increase in the
JSW laterally of 0.6mm bilaterally, but the tracking of the patella
improved. All of this improvement came while the patients’ functions
improved. All met their pretreatment goals except case three, JL, who
did not get back to unlimited competitive tennis. One item not in her
favor is her 5’4”, 200+ pound muscular frame.
Previous attempts at cartilage regeneration have been numerous and
mostly futile.42,43,44,45 While a
number of very complex surgical techniques exist, they require extensive
rehabilitation periods and tremendous expense. Prolotherapy, on the
other hand, is a simple, cost effective, time-efficient alternative.
Prolotherapy injections are an outpatient procedure, taking the
clinician just minutes to perform. Patient activities are virtually
unlimited during the course of Prolotherapy treatments with a gradual
return to pre-injury exercise levels. While the potential is there for
Prolotherapy to improve the quality of life of patients with
degenerative knee arthritis and be a cost savings, future long-term
controlled studies will be needed to assess this.
To the age old question “Can adult articular cartilage cells be
regenerated?” these five knees suggest the answer is “yes.” Each of the
five post-Prolotherapy radiographs revealed an increase in joint space
width which coincided with symptom relief and return of most function.
This suggests in these five degenerated knees that Prolotherapy has the
potential to reverse degenerative knee arthritis. Further research with
a larger patient population and under a more controlled setting is
needed to provide further evidence of cartilage regeneration and
Prolotherapy.
CONCLUSION
Prolotherapy improved the pain and
function in five knees with osteoarthritis. All five degenerated knees
showed evidence of articular cartilage regeneration in their standard
weight-bearing X-rays after Prolotherapy. It is suggested that before
and after X-ray studies can be used to document the response of
degenerated joints to Prolotherapy. Future research is needed with a
larger patient population and under a more controlled setting to further
evidence of clinical responses and cartilage regeneration with
Prolotherapy.
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