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The Science. The Research.

Clinical Studies

 

Abstract

Objective

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.

Design

Prospective, FDA approved pilot study. This study limits treatment to one or two discs regardless of MRI findings. This study allows fibrin injection only into the center nucleus pulposus, and not the outer annulus fibrosus tears. This study utilizes low-specificity discography for pre-treatment diagnosis, because high-specificity annulograms are performed by fewer physicians

Setting

Three tertiary spine centers in the United States.

Subjects

Fifteen adults with chronic, single, or contiguous two‐level lumbar discogenic pain confirmed through discography.

Interventions

Delivery of Fibrin Sealant into symptomatic lumbar disc center nucleus pulposus, and not disc outer annulus fibrosis tears.

Outcome Measures

Assessments were performed at pre-treatment baseline, 72 hours, and week 1, 4, 13, 26, 52, and 104 following treatment. Potential adverse events were evaluated with serial assessment of neurological status, and plain film radiograph, and magnetic resonance imaging (MRI). Efficacy measures included serial Visual Analog Scale (VAS) measurements and the Roland‐Morris Disability Questionnaire (RMDQ).

Results

Safety was demonstrated, with no significant adverse events. Two patients reported self-resolved muscle spasm. X‐ray and MRI demonstrated no adverse changes. One subject (Johns Hopkins site) experienced discitis, and needle aspiration identified normal oral flora, determined to be resultant of concurrent dental procedure, and resolved with antibiotics.

Efficacy

Mean low back pain VAS scores improved from 72.4 (95% c.i. 64.6–80.3) at baseline to 31.7 (17.4–46.1), 35.4 (17.7–53.1), and 33.0 (16.3–49.6).

Function, measured by RMDQ, improved from 15.2 (12.7–17.7) at baseline to 8.9 (5.3–12.5), 6.2 (3.4–9.1), and 5.6 (2.9‐8.4) at 26, 52, and 104 weeks, respectively.

Conclusion

Intradiscal fibrin sealant injection demonstrates safety and efficacy, and provides statistically significant improvement in pain and function. Further research could evaluate likelihood of improving outcomes further through: (a) utilizing more specific diagnostic annulograms instead of discograms; (b) treating every disc with annular tears instead of only one or two; and (c) injecting fibrin directly into annulus fibrosus tears to optimize disc’s containment of nucleus pulposus gel while minimizing its outward displacement.

 

 

 

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Publications

Abstract

Background context

Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.

Purpose

To compare the efficacy of IDET with that of a placebo treatment.

Study design/setting

Randomized, placebo-controlled, prospective trial.

Patient sample

Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features.

Methods

IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients.

Outcome measures

The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale.

Results

Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit.

Conclusions

Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.

NASS Outstanding Paper

RANDOMISED, PLACEBO-CONTROLLED TRIAL OF INTRADISCAL ELECTROTHERMAL THERAPY FOR CHRONIC LOW BACK PAIN · Kevin Pauza, Simon Howell, +4 authors Nikolai Bogduk

· Medicine

· 2003 (1 March 2003)

INTRODUCTION: Intradiscal electrothermal therapy (IDET) is a controversial, new treatment for low back pain, whose efficacy has not been tested in randomised trials. The present study was undertaken to compare the efficacy of IDET with that of a placebo treatment. METHODS: Patients were recruited by referral and by advertising in the media. Of 4,530 individuals who enquired, 1,360 were prepared to submit to randomisation. Of these, 260 were found potentially eligible after clinical examination, and 64 became eligible after discography. All had discogenic low back pain lasting longer than six months, with no co-morbidity. Thirty-seven were allocated to IDET, and 27 to sham therapy. Both groups were satisfactorily matched for demographic and clinical features. IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90°C. Sham therapy consisted of introducing a needle on to the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Follow-up at six months was achieved in over 85% of patients. Pain and disability were assessed using a visual analog scale for pain, the SF-36, the Oswestry disability scale, and the Back Depression Inventory. RESULTS: Patients in both groups exhibited improvements, but improvements in pain, disability, and depression, were significantly greater in the group treated with IDET. Pain scores improved by 24 points in the IDET group compared with 11 in the sham group. Oswestry scores improved by 11 in the IDET group, but only by four in the sham group. More patients deteriorated when subjected to sham treatment, whereas eight patients (25%) achieved greater than 75% relief of pain following IDET. Only one patient did so after sham treatment. The number needed to treat, to achieve 75% relief of pain, was five. No patient suffered any adverse effects. DISCUSSION: IDET fails to provide relief in some 50% of patients. Consequently, its efficacy is difficult to demonstrate statistically. Nevertheless, IDET provides satisfying relief in a substantial proportion of patients. Non-specific factors account for a large proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The efficacy of IDET may be related critically to patient selection and the technique used. Improvements in either of these areas may improve the effect-size of IDET. Meanwhile, IDET is a low risk procedure that constitutes a legitimate option for patients with discogenic low back pain whose only alternative is fusion.

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Abstract

Background context

In a small prospective study assessing 10 symptomatic and 10 asymptomatic subjects, Schellhas et al. compared cervical discography to magnetic resonance imaging. Within that study he reported on the distribution of pain for the C3–C4 to C6–C7 levels. Four years later, Grubb and Ellis reported retrospective data from his 12-year experience using cervical discography from C2–C3 to C7–T1 in 173 patients. To date, no large prospective study defining pain referral patterns for each cervical disc has been performed.

Purpose

To conduct a prospective visual and statistical descriptive study of pain provocation of a cohort of subjects undergoing cervical discography.

Study design/setting

Prospective multicenter descriptive study.

Methods

Pain referral maps were generated for each disc level from patients undergoing cervical discography with at least two levels assessed. If concordant pain was reproduced in a morphologically abnormal disc, the subject immediately completed a pain diagram. An independent observer interviewed the subject and recorded the location of provoked symptoms. Visual data were compiled using a body sector bit map, which consisted of 48 clinically relevant body regions. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Results

A total of 101 symptom provocation maps were recorded during cervical discography on 41 subjects. There were10 at C2–C3, 19 at C3–C4, 27 at C4–C5, 27 at C5–C6, 16 at C6–C7 and 2 at C7–T1. Predominantly unilateral symptoms were provoked just as often as bilateral symptoms. The C2–C3 disc referred pain to the neck, subocciput and face. The C3–C4 disc referred pain to the neck, subocciput, trapezius, anterior neck, face, shoulder, interscapular and limb. The C4–C5 disc referred pain to the neck, shoulder, interscapular, trapezius, extremity, face, chest and subocciput. The C5–C6 disc referred pain to the neck, trapezius, interscapular, suboccipital, anterior neck, chest and face. The C6–C7 disc referred pain to the neck, interscapular, trapezius, shoulder, extremity and subocciput. At C7–T1 we produced neck and interscapular pain. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated.

Conclusions

In conclusion, these results confirm the observations of prior investigators that cervical internal disc disruption can elicit axial and peripheral symptoms. The particular patterns of pain generation allow the discographer to preprocedurally anticipate disc levels to assess. With these data, the number of disc punctures that are required can be limited rather than routinely assessing all cervical discs.

 

 

NASS Outstanding Paper

 

Spine (Phila Pa 1976). 2011 Aug 15;36(18):E1201-9. doi: 10.1097/BRS.0b013e31820566b2.

Biological and biomechanical effects of fibrin injection into porcine intervertebral discs. Buser Z1, Kuelling F, Liu J, Liebenberg E, Thorne KJ, Coughlin D, Lotz JC.

 

Abstract

STUDY DESIGN:

Surgically denucleated porcine intervertebral discs (IVD) were injected with BIOSTAT BIOLOGX Fibrin Sealant (FS), and the in vivo effects were assessed over time by histological, biochemical, and mechanical criteria.

OBJECTIVE:

The objectives were to test whether the intradiscal injection of FS stimulates disc healing.

SUMMARY OF BACKGROUND DATA:

Disc avascularity prevents the deposition of a provisional fibrin scaffold that typically facilitates soft tissue repair. Poor disc wound healing leads to disc damage accumulation and chronic inflammation characterized by overproduction of proinflammatory cytokines and proteolytic enzymes.

METHODS:

Four lumbar IVDs from each of 31 Yucatan minipigs were randomized to untreated controls; degenerative injury (nucleotomy); and nucleotomy plus FS injection. Animals were killed at 1, 2, 3, 6, and 12 weeks postsurgery. IVDs were harvested to quantify (1) architecture using morphological and histological grading; (2) proteoglycan composition using DMMB assay; (3) cytokine content using ELISA; and (4) mechanical properties using quantitative pressure/volume testing.

RESULTS:

There was progressive invasion of annular tissue into the nucleus of nucleotomy discs and concomitant reduction in proteoglycan content. By contrast, FS supplementation inhibited nuclear fibrosis and facilitated proteoglycan content recovery over time. FS discs synthesized significantly less TNF-α than degenerate discs (66% vs. 226%, P < 0.05) and had upregulation of IL-4 (310% vs. 166%) and TGF-β (400% vs. 117%) at 2 to 3 weeks posttreatment. At the third week postsurgery, the denucleated discs were less stiff than controls (pressure modulus 779.9 psi vs. 2754.8 psi; P < 0.05) and failed at lower pressures

(250.5 psi vs. 492.5 psi; P < 0.05). The stiffness and leakage pressure of the FS-treated discs recovered to control values after 6 and 12 weeks, respectively.

CONCLUSION:

FS facilitated structural, compositional, and mechanical repair of the surgically damage

Abstract

STUDY DESIGN:

This prospective study evaluated the diagnostic utility of historically accepted sacroiliac joint tests. A multidisciplinary expert panel recommended 12 of the “best” sacroiliac joint tests to be evaluated against a criterion standard of unequivocal gain relief after an intra-articular injection of local anesthetic into the sacroiliac joint.

OBJECTIVES:

To identify a single sacroiliac joint test or ensemble of test that are sufficiently useful in diagnosing sacroiliac joint disorders to be clinically valuable.

SUMMARY OF BACKGROUND DATA:

No previous research has been done to evaluate any physical test of sacroiliac joint pain against an accepted criterion standard.

METHODS:

Historical data was obtained, and the 12 tests were performed by two examiners on 85 patients who subsequently underwent sacroiliac joint blocks. Ninety percent or more relief was considered a positive response, and less then 90% relief was considered a negative response.

RESULTS:

There were 45 positive and 40 negative responses. No historical feature, none of the 12 sacroiliac joint tests, and no ensemble of these 12 tests demonstrated worthwhile diagnostic value.

CONCLUSION:

Sacroiliac joint pain is resistant to identification by the historical and physical examination data from tests evaluated in this study.

 

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Pauza K, Wright C, Fairbourn A. Techniques of Regional Anesthesia and Pain Management.

Treatment of annular disc tears and “leaky disc syndrome” with fibrin sealant.2015; 19(1-2):45-49.

Treatment of annular disc tears and

“leaky disc syndrome” with fibrin sealant

Abstract The surfaces of annulus fibrosus tears are known harbingers of inflammatory constituents within intervertebral discs, stimulating sensitized nocioceptors within those tears. Other current treatment options of internal disc disruption neglect to specifically address the surface of these tears. Therefore, this investigation answers the question: does nonautologous fibrin sealant applied to the surface of annulus fibrosus tears mechanically glue and seal annular tears? Regarding this query, results suggest nonautologous concentrated fibrin successfully seals annulus fibrosus tears with a “suture-like mechanical sealant,” serving as a safe option for treating symptomatic or nonsymptomatic intervertebral disc tears. Sealing tears prevents pain-generating chemicals of the nucleus pulposus from leaking through annular tears. More specifically, fibrin sealant minimizes or eliminates extravasation of nucleus pulposus through tears and voids within the annulus fibrosus. Moreover, an investigation subjecting discs to an “internal pressure challenge” objectively affirms fibrin׳s ability to seal torn and degenerated discs against a pressure challenge. (1 psi = 6.89476 kPs (disc mean pressure pretreatment = 75.84 kPs; post-treatment = 179.3 kPs: (n = 347, P < 0.001). Therefore, sealing annular tears serves to minimize extravasation of nucleus pulposus through annular tears, thus potentially treating symptoms caused by internal disc disruption, “Leaky Disc Syndrome,” and chemical radiculopathy. Additionally, sealing annular tears potentially allows adjunctive regenerative biologics such as mesenchymal precursor cells, platelet rich plasma, and growth factors to remain within discs, thus, potentially optimizing their efficacy. A prior in vivo investigation demonstrated the vast majority of mesenchymal stem cells leaked from animal intravertebral discs, and another demonstrated radiolabeled mesenchymal stem cells leaked from degenerated discs and were subsequently found within new exuberant osteophytes adjacent to the degenerated disc. Intra-annular nonautologous concentrated fibrin shares a benefit of other intradiscal biologics in that fibrin does not cause aberrant detrimental mechanical forces on adjacent discs, compared with surgical fusion and disc arthrodesis, which

both cause aberrant, potentially damaging mechanical forces on adjacent segments. The mean number of morphologically abnormal lumbar intervertebral discs in this population with chronic low back pain was 3.21 discs.

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Kevin Pauza, M.D.

SPECIALTY

  • Disc Biologics
  • Interventional Spine

EDUCATION & DEGREES

  • Fellowship: Interventional Spine, University of Pennsylvania
  • Residency: PM&R, University of Pennsylvania
  • Internship: Surgery & Medicine, Columbia University College of Physicians and Surgeons
  • Medical Doctorate: Pennsylvania State University College of Medicine
  • Bachelor of Arts: Biology, Lehigh University
  • Bachelor of Arts: Psychology, Lehigh University

CERTIFICATIONS & LICENSES

  • Texas State Medical and Surgical License
  • New York State Medical and Surgical License
  • Florida State Medical and Surgical License

HONORS

  • Lehigh University Four-year Academic Scholarship
  • Magna Cum Laude, Lehigh University
  • Lehigh University President’s Award
  • Lehigh University Tower Society
  • Distinguished Alumnus, Penn State University (selected from 500,000 Penn State alumni)
  • North American Spine Society, Outstanding Paper of the Year, 2003
  • President-Elect, International Spine Intervention Society
  • Founding Partner, Texas Spine and Joint Hospital
  • Commencement Speaker: Penn State University College of Medicine
  • Advisory Board, AMA
    Keynote Speaker, Harvard Pain Center Commencement
  • Founding Chairman, Standards Committee, International Spine Intervention Society
  • Chairman, Spine Committee, Amercian Academy of Physical Medicine & Rehabilitation
  • Appointed Spine Advisor, Japanese Prime Minister
  • Appointed Spine Advisor, Allied Royal Families

EXPERIENCE

  • Founding Partner & Principal, Texas Spine & Joint Hospital

Travis Foxx, M.D. - Premier Anesthesiology & Pain

Brandon Tolman, D.O. - Integrity Center for Regenerative Medicine

Boris Terebuh, M.D. - Regenerative Spine & Joint Center

Boris Terebuh, MD specializes in providing personalized nonsurgical solutions for spine problems that interfere with the function patients desire and the independence they deserve. Dr. Terebuh completed his Physical Medicine & Rehabilitation residency training at The Ohio State University in 1997 and has been in solo practice in Ohio since 2001 because he is committed to providing accessible, individualized and attentive care to his patients. His regenerative approach to solving spine problems enhances the body’s natural ability to heal itself. His guiding principle is integrity – doing what is right for patients in a conscientious manner with the motivation of helping them become fully functional, independent and satisfied. Dr. Terebuh is a very unique Medical Doctor because he has earned seven Board Certifications in the field of musculoskeletal medicine and nonsurgical spine care. Boris Terebuh, MD is delighted to be a Discseel® provider because this revolutionary new technology aligns perfectly with his preferred regenerative treatment approach and patient care philosophy. Dr. Terebuh is also grateful to Discseel® developer, Kevin Pauza, MD, for all the years of diligent and meticulous research to create this innovative, paradigm-shifting intervention, which will certainly spare countless individuals the prospect of avoidable spine surgical procedures.

Thierry Bonnabesse, M.D. - Champlain Spine and Pain Management

Gregory Lutz, M.D. - Regenerative Sportscare Institute

Dr. Gregory Lutz is the Founder and Medical Director of the Regenerative SportsCare Institute (RSI). In addition, he currently serves as Physiatrist-In-Chief Emeritus at Hospital for Special Surgery (HSS) and a Professor of Clinical Rehabilitation Medicine at Weill Medical College of Cornell University. Dr. Lutz is one of the world’s leading experts in the field of regenerative interventional orthopedic medicine, appearing annually on Castle Connolly’s and New York Magazine’s “Top Doctors” lists.

Kevin Pauza, M.D. - Regenerative Sportscare Institute

SPECIALTY

  • Disc Biologics
  • Interventional Spine

EDUCATION & DEGREES

  • Fellowship: Interventional Spine, University of Pennsylvania
  • Residency: PM&R, University of Pennsylvania
  • Internship: Surgery & Medicine, Columbia University College of Physicians and Surgeons
  • Medical Doctorate: Pennsylvania State University College of Medicine
  • Bachelor of Arts: Biology, Lehigh University
  • Bachelor of Arts: Psychology, Lehigh University

CERTIFICATIONS & LICENSES

  • Texas State Medical and Surgical License
  • New York State Medical and Surgical License
  • Florida State Medical and Surgical License

HONORS

  • Lehigh University Four-year Academic Scholarship
  • Magna Cum Laude, Lehigh University
  • Lehigh University President’s Award
  • Lehigh University Tower Society
  • Distinguished Alumnus, Penn State University (selected from 500,000 Penn State alumni)
  • North American Spine Society, Outstanding Paper of the Year, 2003
  • President-Elect, International Spine Intervention Society
  • Founding Partner, Texas Spine and Joint Hospital
  • Commencement Speaker: Penn State University College of Medicine
  • Advisory Board, AMA
    Keynote Speaker, Harvard Pain Center Commencement
  • Founding Chairman, Standards Committee, International Spine Intervention Society
  • Chairman, Spine Committee, Amercian Academy of Physical Medicine & Rehabilitation
  • Appointed Spine Advisor, Japanese Prime Minister
  • Appointed Spine Advisor, Allied Royal Families

EXPERIENCE

  • Founding Partner & Principal, Texas Spine & Joint Hospital

Janet Pearl, M.D. - The Boston Stem Cell Center

Dr. Janet Pearl has been in practice since 1999 and is the Medical Director of The Boston Stem Cell Center. She is also the Medical Director of  Complete Spine and Pain Care  an interventional integrated Pain Management practice, both located in Framingham, Massachusetts. Dr. Pearl is Triple Board Certified in Regenerative Medicine, Pain Medicine and Anesthesiology and has over 20 years experience in doing these procedures.

Previously, Dr. Pearl was the Co-Director of the Pain Management Center at St. Elizabeth’s Medical Center, where she was also the Director of the Pain Management Fellowship program.

After graduating from Harvard College with an A.B. in Applied Mathematics with Economics, Dr. Pearl received a M.Sc. in Health Planning and Financing at the London School of Hygiene and Tropical Medicine. She then received her M.D. from the Columbia College of Physicians and Surgeons, where she represented the Medical School as a senator in the Columbia University Senate.

Watch Dr Pearl give an introduction to The Boston Stem Cell Center

Dr. Pearl completed her internship in Internal Medicine at New England Deaconess Hospital, her residency in Anesthesiology at the Massachusetts General Hospital, and her fellowship in Pain Management at the Brigham and Women’s Hospital. Dr. Pearl was the first resident ever to serve on the Accreditation Council for Graduate Medical Education (ACGME)’s Residency Review Committee for Anesthesiology. She is a Joseph Collins Scholar and a Rotary Scholar and was awarded the AMA/Glaxo Welcome and AMA/Burroughs Welcome Resident Leadership Awards.

From 2004 to 2010, Dr. Pearl served on the University of Massachusetts Board of Trustees. While there she chaired the Committee on Science, Technology and Research, was a member of the Committee on Academic and Student Affairs and the Governance Committee and also served as Vice Chair of the Advancement Committee, and as a member of the Committee on Athletics.

Dr. Pearl is Board Certified in Regenerative Medicine, Pain Medicine and Anesthesiology with the American Board of Regenerative Medicine and the American Board of Anesthesiologists.

Memberships:

  • The American Pain Society;
  • The Massachusetts Medical Society;
  • The Massachusetts Society of Anesthesiologists;
  • The Massachusetts Society of Interventional Pain Physicians;
  • The American Society of Anesthesiologists;
  • The American Society of International Pain Physicians;
  • The American Institute of Ultrasound in Medicine; and,
  • The American Board of Regenerative Medicine.

PUBLIC SERVICE:

  • Member, Massachusetts Department of Industrial Accidents, Health Care Services Board 
  • Member of the Association of Harvard College Class Secretaries and Treasurers
  • Past Member of the Board of Directors of the Harvard Alumni Association
  • Former Member of the Board of Trustees University of Massachusetts. (10/2010 – 10/2014) 

Mark Reecer, M.D. - Fort Wayne Physical Medicine

Dr. Mark Reecer is board certified in Physical Medicine & Rehabilitation and Pain Management. He has over 20 years of work comp experience, and he routinely provides Independent Medical Examinations (IMEs) for the Indiana Workers’ Compensation Board. Dr. Reecer has lectured extensively and has authored multiple publications that promote his specialty and the use of treatment modalities to eliminate pain, improve function and avoid surgery.

Yasuyuki Nonaka, M.D. - ILC International Lumbago Clinic

Dmitry Buyanov, M.D. - IV Infusion Treatment Center

Dr. Buyanov is originally from Kiev, Ukraine. He received his training in Anesthesiology and his Interventional Pain Management Post-Doctoral at Penn State Medical Center, PA. Dr. Buyanov moved to San Antonio in 2003 at which time he was part of a multi-specialty group before he founded Premier Pain Consultants in 2004. His practice has over 5000 active patients in his practice. Dr. Buyanov treats his patients in a cost-effective manner although giving them the best care with interventional pain treatments/procedure to help each patient improve their quality of life. Dr. Buyanov strongly believes in an individualized and multidisciplinary approach to pain management, he believes in the Buddhist saying: “pain is inevitable but suffering is optional”. He works closely with the area internists, physical therapists, chiropractors, psychiatrists, neurologists, and spine surgeons to insure that each patient has the most optimal individualized treatment plan. Dr. Buyanov enjoys spending his spare time with his children.

Desmond Hussey, M.D. - NASA Neuroscience and Spine Associates. P.L

Dr. Hussey earned his undergraduate degree from Dartmouth College, and proceeded to earn his Medical Degree from The University of Miami School of Medicine. He then attended Northwestern University Internal Medicine Program, followed by a Neurology Residency Program at Emory University. Dr. Hussey continued his specialty training at John Hopkins University pain clinic. A member of The Spinal Injection Society and The American Academy of Neurology and Psychiatry.

Haley Burke, M.D. - Mile High Sports and Rehab

Dr. Burke is board-certified in both Interventional Pain Management and Neurology and has completed an accredited Pain Fellowship with the Department of Anesthesiology at MD Anderson Cancer Center, one of the nation’s most prestigious hospitals. Dr. Burke completed her residency in Neurology at the University of Colorado, where she received the department’s ‘Excellence in Teaching’ award during her year as Chief Resident. Her Doctor of Medicine degree was completed at the University of Texas Health Science Center, where she was elected to the ‘Gold Humanism Honor Society.’

Maxim Moradian, M.D. - Interventional Spine Care & Orthopedic Regenerative Experts

Dr. Moradian is triple-board certified in Physical Medicine and Rehabilitation (PM&R), Sports Medicine and Pain Management. Dr. Moradian’s clinical practice is devoted to the comprehensive care of spine, joint, muscle, tendon, ligament, and peripheral nerve disorders. He is proficient in performing advanced, minimally-invasive procedures under fluoroscopic and/or ultrasound guidance in the entire spine. Dr. Moradian performs electrodiagnostic testing (EMG/NCS) for the accurate diagnosis of muscle and/or nerve disorders. He has a special interest in regenerative medicine, sports concussions, neuromuscular ultrasound, medical education, and clinical research. His true passion is to treat his patients like his family and friends.

Wendi Lundquist, D.O. - Active Life Physical Medicine & Pain Center

Dr. Lundquist is the Medical Director and founder of Active Life Physical Medicine & Pain Center, Innovative Surgery Center, and Regena Spa. She is dual board certified in Physical Medicine and Rehabilitation along with Pain Management and a diplomat with the American Board of Pain Medicine. She completed her training at Loyola University in Chicago, Illinois in July of 2005. During her time there, she served as Chief Resident and was involved in several research projects. Prior to, she completed medical school at Midwestern University at the Arizona College of Osteopathic Medicine campus in Glendale, Arizona and internship at Doctors Hospital in Massillon, Ohio. She also has a Bachelor of Science in Biology and minor in Chemistry from the University of New Mexico in Albuquerque. She has a special interest in sports medicine, pain and spine. With 17 years experience, she has great enthusiasm towards regenerative medicine.

Kevin Pauza, M.D. - Turtle Creek Surgery Center

Prior to attending Penn State University, Dr. Pauza earned his undergraduate degree from Lehigh University, and furthered his training with a Surgical and Medical Internship at Columbia University College of Physicians and Surgeons. He continued his specialty training at the University of Pennsylvania, followed by an Interventional Spine Fellowship. In addition to his research, philanthropic, and clinical endeavors, Dr. Pauza remains a motivated educator. He established a Spine Fellowship program and continues training physicians from around the world. He heads international committees responsible for establishing standards and educating surgical and non-surgical physicians.

After helping hundreds of patients who failed to experience relief after spine surgery, it became evident to Dr. Pauza that current methods needed to change. This motivated him to seek better ways to help patients, by thinking outside the box.

Dr. Pauza is the first physician in history to pursue FDA approval for using biologics to treat the spine. Millions of patients will benefit from his development of minimally invasive treatments for degenerative disc disease and other more common and serious disorders of the spine.

SPECIALTY

  • Disc Biologics
  • Interventional Spine

EDUCATION & DEGREES

  • Fellowship: Interventional Spine, University of Pennsylvania
  • Residency: PM&R, University of Pennsylvania
  • Internship: Surgery & Medicine, Columbia University College of Physicians and Surgeons
  • Medical Doctorate: Pennsylvania State University College of Medicine
  • Bachelor of Arts: Biology, Lehigh University
  • Bachelor of Arts: Psychology, Lehigh University

CERTIFICATIONS & LICENSES

  • Texas State Medical and Surgical License
  • New York State Medical and Surgical License
  • Florida State Medical and Surgical License

HONORS

  • Lehigh University Four-year Academic Scholarship
  • Magna Cum Laude, Lehigh University
  • Lehigh University President’s Award
  • Lehigh University Tower Society
  • Distinguished Alumnus, Penn State University (selected from 500,000 Penn State alumni)
  • North American Spine Society, Outstanding Paper of the Year, 2003
  • President-Elect, International Spine Intervention Society
  • Founding Partner, Texas Spine and Joint Hospital
  • Commencement Speaker: Penn State University College of Medicine
  • Advisory Board, AMA
    Keynote Speaker, Harvard Pain Center Commencement
  • Founding Chairman, Standards Committee, International Spine Intervention Society
  • Chairman, Spine Committee, Amercian Academy of Physical Medicine & Rehabilitation
  • Appointed Spine Advisor, Japanese Prime Minister
  • Appointed Spine Advisor, Allied Royal Families

EXPERIENCE

  • Founding Partner & Principal, Texas Spine & Joint Hospital

Haley Burke, M.D. - Colorado Rehabilitation & Occupational Medicine

Dr. Burke is board-certified in both Interventional Pain Management and Neurology and has completed an accredited Pain Fellowship with the Department of Anesthesiology at MD Anderson Cancer Center, one of the nation’s most prestigious hospitals. Dr. Burke completed her residency in Neurology at the University of Colorado, where she received the department’s ‘Excellence in Teaching’ award during her year as Chief Resident. Her Doctor of Medicine degree was completed at the University of Texas Health Science Center, where she was elected to the ‘Gold Humanism Honor Society.’

Haley Burke, M.D. - Colorado Rehabilitation & Occupational Medicine

Dr. Burke is board-certified in both Interventional Pain Management and Neurology and has completed an accredited Pain Fellowship with the Department of Anesthesiology at MD Anderson Cancer Center, one of the nation’s most prestigious hospitals. Dr. Burke completed her residency in Neurology at the University of Colorado, where she received the department’s ‘Excellence in Teaching’ award during her year as Chief Resident. Her Doctor of Medicine degree was completed at the University of Texas Health Science Center, where she was elected to the ‘Gold Humanism Honor Society.’

Matthias H. Wiederholz, M.D.

Founding Partner, Triple Board Certified – Physical Medicine & Rehabilitation; Sports Medicine; Anti-Aging, Regenerative & Functional Medicine

Dr. Matthias H. Wiederholz is cofounder of Performance Spine & Sports Medicine, LLC. He is a fellowship-trained interventional pain physician whose clinical interests include: Interventional Pain Management, Sports Medicine, Musculoskeletal Medicine, Minimally-Invasive Spine Surgery, Non-Surgical Orthopedics, and Anti-Aging / Functional Medicine.

He received his specialty training in Physical Medicine and Rehabilitation at Baylor College of Medicine in Houston, Texas where he served as chief resident. He completed fellowship training in Interventional Pain Management in Marietta, Georgia. He is board-certified in Physical Medicine & Rehabilitation and Sports Medicine. He also received advanced fellowship training through the American Academy of Anti-Aging Medicine and is board-certified in Anti-Aging, Regenerative & Functional Medicine.

Dr. Wiederholz performs a myriad of interventional pain procedures including, but not limited to the following: epidural steroid injections, facet joint injections, radiofrequency ablation, sacroiliac joint injections, discography, percutaneous disc decompression, epidural lysis of adhesions spinal cord stimulator implants, and minimally-invasive discectomies. Endoscopic spine surgery is a very unique and valuable tool in his armamentarium and makes Dr. Wiederholz one of the most specialized physicians in the field of Pain Medicine.

Dr. Wiederholz uses musculoskeletal ultrasound in the diagnosis of musculoskeletal injuries. He incorporates ultrasound for precise injection therapy including cortisone injections, prolotherapy, and PRP (platelet rich plasma). This technology is also utilized to perform the Tenex procedure, a percutaneous procedure for treating chronic tendon pain (tennis elbow, rotator cuff, plantar fasciitis, etc).

Dr. Wiederholz is the fellowship director for the sports and spine fellowship at Performance Spine & Sports Medicine. Dr. Wiederholz holds an affiliation with Capital Health System and JFK Johnson Rehabilitation Institute.

Being advanced fellowship trained in Anti-Aging, Regenerative & Functional Medicine means that Dr. Wiederholz has the most advanced training in Anti-Aging Medicine available. He is a leading expert in Bio-Identical Hormone Restoration and helps patients achieve wellness through nutrition, lifestyle, and hormone therapies.

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Michael Wolff, M.D. - Southwest Spine & Sports