Prolotherapy: An Evidence-Based Adjunctive Therapy for Knee Osteoarthritis

Am Fam Physician. 2021 Apr 1;103(7):395.

Original Article: Chronic Musculoskeletal Pain: Nonpharmacologic, Noninvasive Treatments

Issue Date: October 15, 2020

Available at: https://www.aafp.org/afp/2020/1015/p465.html

To the Editor: We appreciate the article on therapeutic options for chronic musculoskeletal pain by Dr. Flynn. We want to highlight prolotherapy, an injection-based modality for chronic pain with protocols targeting intra- and extra-articular pain-generating tissue. Prolotherapy is supported by a growing body of literature reporting effectiveness for several chronic pain conditions, particularly knee osteoarthritis.

Prolotherapy dates from at least 1937 (then called sclerotherapy because of the observation that early, more caustic solutions caused scarring).¹ Small volumes of a therapeutic solution, typically dextrose, are injected within the affected joint and at the bony attachments of tender tendons and ligaments around the joint. Injections are typically given monthly over three to six sessions. The mechanism of action is unclear; inflammatory and nerve-specific effects are hypothesized.²

A rigorous randomized clinical trial assessed the effectiveness of prolotherapy for knee osteoarthritis.³ One year after treatment, participants receiving prolotherapy reported statistically significant and clinically important improvements on a validated questionnaire compared with participants in two different control groups (blinded injection and at-home exercise). These findings have been corroborated in other clinical trials.⁴ Data from some have been subjected to systematic review and meta-analysis, with positive results.⁵ Satisfaction with prolotherapy in these studies was high, and there were no adverse events.

The prolotherapy protocol is appropriate for outpatient family medicine but requires training not typically available in residency and fellowship programs. Two nonprofit professional organizations offer such training: the Hackett Hemwall Patterson Foundation (https://hhpfoundation.org/education/conferences/clinical-conference-october/) and the International Association for Regenerative Therapy (https://www.iart.org/About). These sibling organizations offer CME-eligible training through academic conference and service-learning activities in collaboration with the University of Wisconsin.⁶

Although more studies are needed to better understand prolotherapy's mechanism of action and clinical utility at the system level, existing literature supports considering prolotherapy in carefully selected patients with symptomatic knee osteoarthritis refractory to other care modalities.

David Rabago, MD

Hershey, Pa.

Brian Ralston, MD

Berwyn, Ill.

Email: brian.ralston@lumc.edu

Annette Zaharoff, MD

San Antonio, Tex.

Author disclosure: Dr. Rabago is past president of the Hackett Hemwall Patterson Foundation. Dr. Ralston is the president of the Hackett Hemwall Patterson Foundation. Dr. Zaharoff is the president of the International Association for Regenerative Therapy and serves on the board of directors for the Hackett Hem-wall Patterson Foundation.

REFERENCES

show all references

1. Schultz LW. A treatment for subluxation of the temporomandibular joint. JAMA. 1937;109(13):1032–1035....

In Reply: Thank you for your letter in response to my review of nonpharmacologic, noninvasive therapies for chronic musculoskeletal pain. Prolotherapy was outside the scope of the article, which did not include the evaluation of injection therapies. I agree that in a small number of clinical trials of knee osteoarthritis involving small sample sizes, study participants who received prolotherapy experienced small treatment effects compared with control participants. However, it is noteworthy that due to the limited quality of these studies, the 2019 American College of Rheumatology osteoarthritis treatment guidelines conditionally recommended against the use of prolotherapy for knee or hip osteoarthritis.¹

Diane M. Flynn, MD, MPH

Tacoma, Wash.

Email: diane.m.flynn4.civ@mail.mil

Author disclosure: No relevant financial affiliations.

REFERENCE

1. Kolasinski S, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care Res. 2020;72(2):149–162.

From the Hackett Hemwall Patterson Foundation (HHPF)

Did you know HHPF provides vein care to hundreds of people in Honduras each year?

Each March, the HHPF Vein Team travels to Honduras for a week of intensive phlebology training and treating of severe venous disease.  Over the years the numbers of physicians, nurses and assistants has increased from just a handful of volunteers to 80-90 people, treating patients in clinics in three cities in Honduras.

When one volunteer first traveled with the group over 25 years ago, she thought that it must be a cultural "custom" for many women to wear long skirts and pants even in the extremely warm weather in Honduras.  She soon realized why women wore long clothing; it was often to conceal the large open ulcers on their legs.  

Changing lives and providing hope HHPF has been able to help change the personal and financial parts of our patient's lives in Honduras. In developed countries, treatment of multiple severe vein problems often occurs over several months.  In Honduras, due to the limited time and resources we have, that same treatment may take years.   A patient comes to our clinics with severe pathology, we treat the worst of the worst veins, and ask the patient to return the following March.  On the positive side, we get to know our returning patients and value the relationships we are able to develop.  Even with language and cultural barriers, friendships and professional relationships develop. This work, the dramatic help for these debilitating venous conditions, would not happen without the Hackett Hemwall Patterson Foundation and support from people like you.  We, the volunteers,  are thankful that the HHPF gives us the opportunity to improve the lives of the people of Honduras as we enrich our own.

REGISTER TODAY 

This year’s program will focus on the diagnosis and treatment of chronic pain with prolotherapy and perineural injection therapy. 

Over 20 speakers from around the world will be presenting a series of 4 sessions over 3 days. The first session will provide an overview of current and emerging concepts in Regenerative Medicine practice.  The remaining 3 sessions will focus on the diagnosis and treatment of lower extremity injuries.  All sessions will conclude with a panel discussion and question and answer opportunity with the speakers from that session.  The current schedule includes: 

Session 1 (Introduction): October 23 from 1pm – 5pm CST 

• Welcome & Overview 

• Clinical Biotensegrity 

• Introduction to and Mechanism of Prolotherapy 

• Introduction to Perineural Injection Therapy 

• Review of Evidence-Based Supporting Prolotherapy 

• Autologous Biologics 

• Lifestyle & Functional Medicine to Improve Regenerative Outcomes 

• Marketing a Regenerative Practice  

Session 2 (Hip): October 24 from 8am – 12pm CST 

• Physical Exam and Differential Diagnosis 

• Anatomy, Palpation, Marking, and Injections Technique 

• ProloSound® Technique 

• Neural Anatomy, Treatment Demonstration and US Nerve Hydrodissection 

• Platelet Rich Plasma Injection for Chronic Musculoskeletal Pain 

Session 3 (Knee): October 24 from 1pm – 5pm CST 

• Physical Exam and Differential Diagnosis 

• Anatomy, Palpation, Marking, and Injection Technique 

• ProloSound® Technique 

• Neural Anatomy, Treatment, and Ultrasound Nerve Hydrodissection  

• Prolotherapy for Knee OA is Supported by High Level of Evidence 

Session 4 (Ankle and Foot): October 25 from 8am – 12pm CST 

• Physical Exam and Differential Diagnosis 

• Anatomy, Palpation, Marking, and Injection Technique 

• ProloSound® Technique 

• Neural Treatment and Ultrasound Nerve Hydrodissection 

• New Frontiers in Injection Therapy 

A special thank you to the 2020 Online Conference Planning Committee: 

Liza Maniquis-Smigel, MD - Chair 

Bobby Nourani, DO 

Will Mora, MD 

Eric Phillippi, MD 

David Rabago, MD 

Ripal Parikh, DO 

Joel Baumgartner, MD 

For registration and updated information, please visit CLICK HERE.

Life has changed for everyone in the last 8 months and invited us to become flexible and adaptable to changes related to the pandemic; and businesses, professional associations and organizations are no exception. As Albert Einstein said, “in the midst of every crisis, lies great opportunity.”

We all know the crisis, but I want to share IART’s response to the opportunity side of this equation. We can all appreciate that “pre-COVID” in-person platforms for learning may now pose a health and safety threat. To that end, IART has re-grouped. IART has developed new strategies to provide educational trainings in prolotherapy and regenerative treatments for physicians. To support these strategies, IART has expanded its Board of Directors and reorganized our governance structure. IART is adapting to a future of unknowns and is creating new paths to learn prolotherapy and support the professional development of physicians.

In the first time in history, the 2020 October Prolotherapy Conference in Madison, Wisconsin will be virtual. The opportunity you ask. More people will be able to access the program, no travel expenses, it poses no health or safety threats, it will be recorded for future viewing, and the program content has been expanded. More information is available on the IART website. We look forward to your participation.

IART has also created the “Web Connections” series. This is a virtual meeting platform to learn and share pertinent information about our profession and practices. The first Web Connection was held on July 28 with our panelists discussing the effects of and response to the pandemic and their practices. If you missed the meeting, please feel free to hear a recording of the discussion on our website.

We have expanded our Board and Committee structures. The opportunity you ask. More people and therefore more skills and wisdom are involved to strategize to support IART members and colleagues. Our committees are focused on training materials (Training Module Committee), online conferences (Online Conference Committee) and communication (Communication Committee). Please welcome our Board of Directors and Committee members.

We are all in this together. IART wants to support you and adapt to the unknowns we are all dealing with. Thank you to all our members and to those of you that have not yet joined, please consider it.

Wishing everyone health and safety for you and your families.

Z

Annette Zaharoff, MD
President, IART
HHPF, Board member

After much consideration, the International Association for Regenerative Therapy has decided not to hold the 2020 Annual Prolotherapy Conference live in person in Madison this October 23-25.  This difficult decision was made due to ongoing COVID-19 concerns.  We want to protect attendee and staff safety, and we felt that potential travel restrictions and possibly the budget restrictions of potential attendees and stresses of reopening practices would interfere with a successful conference of that type in the coming months.

However, we plan to present our conference in a virtual setting. We will share more details as soon possible, but our goal is to make available much of the usual conference content, as well as updated research and hopefully some exciting new content for advanced learners as well and to have it available online.  Registration will be opened for this virtual event as soon as the schedule is confirmed.

IART is committed to doing our part to keep people safe and to reduce the spread of this pandemic. Thank you for your understanding and flexibility!

Sincerely,

Annette Zaharoff, MD, IART President

August 2019

I am writing you to provide an update on the recently formed International Association for Regenerative Therapy (IART.) At the October 2018 HHPF Madison Conference, it was announced that after a lengthy study by the HHPF Board and its governance team, a new aligned association would be created to sustain and expand regenerative medicine treatments such as prolotherapy. I am happy to report that the new "International Association for Regenerative Therapy" (IART) is set to launch this fall!

With the support of the HHPF Board, I have been selected to serve as President of the new IART Board. I am very excited and honored to serve in this position. Two colleagues have also joined the IART board: Adam Balin, MD, serving as Treasurer, and Martin Gallagher, MD as Vice President. IART will serve as an independent organization yet remain aligned with HHPF. IART will focus on education and training while HHPF will focus on service and other philanthropic endeavors to advance the treatment of chronic pain. We wish to maintain the passion and values that have made HHPF such an inviting organization.

IART's mission will be to teach globally, certify professionals in prolotherapy and other regenerative medicine treatments and to share innovative techniques to treat chronic pain and relieve suffering. IART will be a professional membership association that will:

• Offer membership for medical professionals interested in using prolotherapy and other regenerative therapies as a treatment for chronic pain;
• Partner with HHPF to host the annual prolotherapy conference in Madison starting in 2020;
• Develop other educational trainings and materials in prolotherapy and other regenerative therapies;
• Provide mentorship and networking opportunities for medical professionals;
• Certify practitioners of prolotherapy and over time, other regenerative therapies; and
• Advocate for the increased availability of regenerative therapies.

The IART Board has been busy building the new association. Since October 2018, we have:

• Successfully completed all the legal steps to secure IART's corporate, non-profit status.
• Developed an inclusive membership structure that is open to health care providers, individuals or organizations interested in practicing, learning, teaching, researching and supporting prolotherapy and other regenerative therapies to treat pain and improve function.
• Hired an association management company, Badger Bay, to manage the association's operations. Their work is initially focused on membership recruitment, website and social media development, board and organizational development, and accounting.
• Negotiated the transfer of ownership of the HHPF Procedural Guide to IART.
• Developed a logo and branding for the new association.
• Identified prospective members and prepared for an initial membership launch.
• And developed a board, officer and committee structure to support current and long-term plans. 

Our next major step is to launch our membership which will include several membership categories along with the opportunity to become a founding member. More information on membership is coming soon!

While I've shared the most recent news about IART, HHPF is also focusing on its mission of philanthropy and service to relieve suffering from chronic pain. The Foundation will fundraise to support:

• Medical service trips that offer Prolotherapy, ENT and vein therapies to underserved populations
• Service-learning trips to Honduras and Mexico; and
• Grants and awards for training and research projects that advance the treatment of chronic pain.

I will keep you informed about IART's launch. This is an incredibly exciting effort and there are many details that still need to be finalized. We are grateful for HHPF's support and look forward to sharing the message of both organizations with others.

If you have any questions, please feel free to contact me or the IART office.

Sincerely,

Annette Zaharoff, MD

President

(210)219-5920

amzsportsmd@msn.com

Martin Gallagher, MD

Vice President gpmmwa@gmail.com

Adam Balin, MD

Treasurer ahbalin@gmail.com

An annual service-learning experience that has close ties to the University of Wisconsin Department of Family Medicine and Community Health (DFMCH) celebrates its 50^th year.

Since 1969, a team of physicians, nurses, learners and assistants—many affiliated with the DFMCH—have traveled to rural Honduras each March to provide free prolotherapy services for people with chronic musculoskeletal pain, and to teach prolotherapy to clinicians from around the world.

Prolotherapy is an injection-based outpatient therapy that’s has been practiced for over a century. It can help decrease the impact of chronic musculoskeletal pain due to osteoarthritis, overuse syndromes, trauma and sports injuries. The DFMCH has been a hub for clinical and research expertise in prolotherapy for decades.

The Hackett-Hemwall Foundation organizes a medical mission training course every March. JOP columnist and Prolotherapist, Gary B. Clark, MD, MPA, reviews the fortieth anniversary of the Hemwall Honduran program, which occurred in March 2009. The HHF course is the largest Prolotherapy training program of its kind. This physician group provides medical care to over 4,000 Honduran patients annually. Dr. Clark’s article reflects on the history of the program, along with how far it has come and continues to reach.

Journal of Prolotherapy. 2009;1(4):246-248.

In rural Honduras, women often bear many children and work very hard for their entire lives, providing the necessary help to their families that only a mother can give. These women have no 401k retirement funds or paid vacations. If such a woman becomes disabled, she cannot hire a nanny to take her place—if she works at all, she already works as the nanny. So, if such a woman ails, her entire family suffers.

Such was the case last March for a 60-year-old woman who stoically limped into the Honduran Red Cross (Crus Rojas Hondurena) clinic in La Ceiba, Honduras. Yes, she limped—but she had the fire in her eye of pride and independence. She had walked all the way to the intra-city clinic from her rural village outside of La Ceiba. Her painful gait was caused by a sore and swollen knee.

The limp-provoking knee had weighed down this woman for twenty aching years while she unfailingly continued her daily chores and supported her family’s needs. It had been plaguing her daily existence for all that time, slowly but surely becoming progressively worse as each year went by—an all too common story in rural Honduras. But, in the matter of just the next hour, the cause of her knee disability would be specifically diagnosed by careful history and physical examination and set upon the course of healing by a simple, almost painless injection technique wielded by an American physician.

Every March a select team of over 100 dedicated doctors and health-care workers from the United States, Canada, and several other countries of the world visits La Ceiba and two other small towns near the northern Honduran Caribbean coast. Over three weeks, this team of doctors, nurses, technicians, interpreters, and other dedicated volunteers provides careful treatment to over 3,000 patients with multi-joint injury, complicated varicose vein disease, dental disease, and otolaryngologic disease. At the same time that qualified physicians are performing the treatments, they are being guided by mentors, one-on-one. You can figure out the workload performed in a hot, tropical climate and, at the same time, having to work through a volunteer interpreter. As one well-seasoned but first-year doc put it: “Wow! I haven’t worked so hard since internship! This is fabulous!”

It happens every March in Honduras.

Left to right: With their indispensable Honduran interpreter, Gary B. Clark, MD, and Joseph P. Mullane, MD, treat a patient’s knee for multiple ligament sprain injuries.

So, why Honduras? In 1968, Gus Hemwall, an MD Prolotherapist from the Chicago area, met a Honduran pediatrician at a medical meeting in the United States. The Honduran physician was not only from the coastal town of La Ceiba but just happened to be the Vice President of Honduras. The Honduran doctor invited Gus to bring Prolotherapy to La Ceiba. On that invitation, Dr. Hemwall first visited La Ceiba in 1968 and met Lester and Margaret Beckman. Lester “Beck” Beckman was Assistant General Manager for Dole Fruit Company at the time.

That first visit spurred Gus to organizing a yearly trip with like-motivated physicians to La Ceiba. Aided by the Beckmans, the Dole Fruit Company, and the Honduran Red Cross, this small band of philanthropic doctors began making a difference in the lives of the rural and urban Honduran people. From the very beginning, the Beckman’s were staunch supporters of the Honduran medical project, offering their time, their home, and their fortune. Since then, many a physician has learned and, in turn, has taught the basics of Prolotherapy aided initially by American and Canadian teachers, armed with Netter’s Anatomy and a rickety old skeleton—all nestled under the welcome shade of the huge mango tree in Lester’s and Margaret’s backyard.

Left to right: Chet Hermansen, Margaret Beckman, Mary Doherty, and Jeffery Patterson, DO, as Jeff acknowledges Margaret’s forty years of gracious service to HHF and the Honduran people.

Gus planned the first medical project for later in September 1968. However, as Margaret relates the story, it was very rainy at that time, so the first project was rescheduled for March 1969. There were only 7 people on the first medical mission trip. But, it was not too long before the project eventually became much larger and very diverse in its organization. In its largest year, there were 150 MDs, DDSs, RNs, engineers, medical assistants, drivers, and cooks and the medical care provided was of a broad medical-surgical spectrum.

Jeff Patterson’s first year in Honduras was in 1987, when he served in the small coastal town of Tela on invitation by Dr. Hemwall. In 1994, Dr. Hemwall refocused the project on providing just Prolotherapy and Vein Therapy. Dr. Hemwall’s last year in La Ceiba was 1997. In 1998, Gus Hemwall died while attending a Prolotherapy conference.

Dr. Hemwall always conducted the Honduran gathering in a medical mission style. This style has been carried on by Jeff Patterson as much as possible. Through 2005, it was common for the entire group to assemble at Margaret’s home for supper after a very long day’s work—before the 1-2 hour long evening didactic Prolotherapy lecture. The entire group would always pause around Margaret’s dining room table—heavily laden with that evening’s scrumptious meal—to give united thanks for their good fortune to be in the succor of Margaret’s home and to be able to help the Honduran people. That evening dinner grace has been led by healthcare providers of many spiritual persuasions.

Honduran patient receiving Prolotherapy to the neck and thoracic spine. “Kids, don’t try this at home.”

The Hackett-Hemwall Honduran Program now includes three treatment locations:

• La Ceiba is a city of approximately 100,000 people, lying at the foot of 5000 feet Pico Bonito, and still a major banana port. The work there is sponsored by the local Honduran Red Cross.
• Tela, of approximately 50,000 people, is a seaside town and former home of the Tela Railroad Company, producers of Chiquita Bananas. The work there is sponsored by the Tela Evangelical Church.
• Olanchito, of approximately 30,000 people, is located further inland within the mountains. The work there is sponsored by the Sociedad de Agriculturores y Gandares de Olanchito.

Dr. Hemwall’s pioneering efforts have since continued through the Hackett-Hemwall Foundation (HHF), which continues Gus’ dream for the Hondurans and other nationalities. The Foundation is led by a handful of dedicated osteopathic and medical doctors centered in Madison, Wisconsin, under the direction of Dr. Jeffrey Patterson, administrated by Mary Doherty, and supported academically by the University of Wisconsin. HHF has grown to include healthcare work in Honduras, Mexico, and the Philippines.

The Foundation has 3 basic goals: education, research, and medical care. In keeping with its goal of education, their Prolotherapy Program is the largest training program of its kind in the world. HHF considers Prolotherapy as a surgical subspecialty that requires significant education and practical hands-on training to perform really well. Consequently, HHF strives to provide the best Prolotherapy training available to physicians anywhere in the world. Over the years, the Foundation has trained hundreds of physicians in Prolotherapy from eighteen different countries.

The HHF Vein Program, under the direction of Rick Owens, MD, is expanding and providing similar education and clinical care. Dr. Owens has brought his and other phlebologists’ expertise to provide ultrasound-guided vein sclerosis to the Honduran people using the most up-to-date vein sclerosing techniques. Physicians from across the United States and Canada travel with their ultrasound machines to share their knowledge and skills and to treat hundreds of extremely needy patients with horribly severe varicose vein disease—you have to see one of these weeping, crusted ulcers to realize what “horrible” really means. The HHF ENT program (which occurs in February) is under the direction of Michael McDonald, MD. The Dental Program is under the direction of Dana Lubet, DDS.

Left to right: Irene Briceno, MD, and Stephen Cavillino, MD, perform cervical spine Prolotherapy.

HHF has fostered a working relationship with the medical school in Tegucigalpa, Honduras, to train anesthesiology residents—much through the continuous effort of Dan Wert, DO. HHF is actively establishing relationships with medical schools in Honduras, Nicaragua and Guadalajara, Mexico. Likewise, HHF has fostered excellent working relationships with local Honduran physicians who receive HHF training in joint and vein therapies.

The entire group of HHF doctors and supportive staff at Tela.

In supporting research, HHF continues to fund ongoing basic and clinical research in Prolotherapy.

In providing medical care, HHF is currently providing medical care to approximately 4,000 Honduran patients yearly, providing Prolotherapy, Vein Sclerosing, ENT Surgery and Dental Care. In addition, HHF works with local Honduran schools and hospitals, providing them with supply and logistical needs. HHF is following suit in Mexico and the Philippines, treating hundreds more there, as well.

This group picture was taken during the 1993 Honduras trip. Dr. Hemwall is in the backseat of the truck. His legacy lives on, every March in Honduras.

As for the 60-year-spry Honduran lady in La Ceiba last March? She—along with the hundreds of others who made their way to the Honduran Red Cross that week—happily returned to her home and family. An American doctor had treated her knee by using Prolotherapy. She had been definitively treated and was bolstered with reaffirmed hope—for the first time in years—of finally being free of disabling pain.

It happens every March in Honduras.

Acknowledgment

Portions for this article were taken from the magazine of The International Society for the Study of Subtle Energies and Energy Medicine (ISSEEEM): It Happens Every March in Honduras, Gary B. Clark, M.D., M.P.A., with interview material from Carol Schneider, Ph.D., Bridges, Volume 16, Number 4, Winter, 2005.