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Prolotherapy Studies

 

Introduction to Prolotherapy

Why Get Prolotherapy? Donna Alderman, D.O.
When you become a physician, you take the Hippocratic Oath. The first rule of the Hippocratic Oath is "First of all, do no harm." This is why Prolotherapy appealed to me as a physician. I was a doctor at a famous HMO. After learning Prolotherapy, however, I went into private practice.

What is Prolotherapy? Alvin Stein, M.D.
Prolotherapy is also known as non-surgical ligament reconstruction, and is a permanent treatment for chronic pain. Prolotherapy is derived from the Latin word "proli" which means to regenerate or rebuild. It is important to understand what the word PROLOTHERAPY itself means. "Prolo" is short for proliferation, because the treatment causes the proliferation (growth, formation) of new ligament tissue in areas where it has become weak.

Introduction to Prolotherapy Ross Hauser, M.D.
Prolotherapy is a simple, natural technique that stimulates the body to repair the painful area when the natural healing process needs a little assistance.

How Safe Is Prolotherapy? Ross Hauser, M.D.
In now over four decades, no serious side effects from Prolotherapy have been reported in the medical literature despite millions of Prolotherapy treatments given. Prolotherapy is not dangerous, Prolotherapy cures chronic pain.

The Importance of an Experienced Prolotherapist Ross Hauser, M.D.
Because of the numerous calls we receive, we have a good idea, (the good, the bad, and the ugly) about what is happening with Prolotherapy around the country. Remember that not all Prolotherapists are created equal and the proof is some of the things our patients have told us and what we have heard from other physicians.

Non-Surgical Tendon, Ligament and Joint Reconstruction William J. Faber, D.O.
In acute injuries, the ligaments and tendons become torn. Ligaments function to limit the range of motion that bones can move between each other, and function to stabilize joints and hold the joint together. Tendons function to attach a muscle to bone in order to provide motion. Discs and cartilage serve to absorb shock and keep the bones from rubbing against one another. If the ligaments become torn or over-stretched the joint becomes unstable and resultant friction causes the discs or cartilage to become worn down causing a loss of height.

How Does Prolotherapy Work? Marc Darrow, M.D.
The term "Prolotherapy" is short for "proliferation therapy." Proliferation, of course, means "rapid production."
What Prolotherapy rapidly produces is collagen and cartilage. Collagen is a naturally occurring protein in the body that is a necessary element for the formation of new connective tissue—the tissues that holds our skeletal infrastructure together. These tissues include, tendons, ligaments, muscle fascia and joint capsular tissue.

When Prolotherapy May Not Work David Harris, M.D.  
Prolotherapy is effective in markedly reducing or curing musculoskeletal pain 80-90% of the time. Many end-stage medical problems are worth a trial of prolotherapy, especially if the only alternative is a destructive or permanent alteration of a joint, such as a surgical fusion or the destruction of a nerve. The greater the anatomical injury, the more difficult it is resolving the problem.

Twenty Common Questions About Prolotherapy David Harris, M.D.

The History of Prolotherapy Ross Hauser, M.D.
The concept of Prolotherapy originated in the non-surgical treatment of hernias, varicose veins, and hemorrhoids, all conditions which are due to connective tissue weakness. If the connective tissue in the veins becomes weakened, hemorrhoids and varicose veins form. Weakness in the collagen, of course, causes ligament laxity and tendon degeneration with resultant chronic pain.

Curing Chronic Pain with Prolotherapy Scott Greenberg, M.D.
Have you ever suffered from chronic musculoskeletal pain? If you have, you are not alone. Statistically speaking, 75% of Americans will experience chronic back pain in their lifetime. Unfortunately, a stressful and active lifestyle may not give our body the chance it deserves to heal.

Why So Many Turn To Prolotherapy David Harris, M.D.
The conventional model of pain management relies on medications, such as anti-inflammatory drugs, antidepressants, anti-seizure medications, opiates such as Vicodin and Codiene, “muscle-relaxant” medications related to Valium (which actually act as “brain-relaxants”), and other potentially addictive and risky medications.

Prolotherapy and Chronic Pain Ross Hauser, M.D.
It is not a secret that chronic musculoskeletal pain is the number one cause of chronic disability in North America. Nor is it a secret that chronic back pain is the leading cause of disability in Americans under the age of 45. What is a secret is that this rampaging epidemic of pain can conceivably be eliminated in 80-90% of sufferers.

Peripheral Joints & Prolotherapy Jay W. Nielsen, M.D.

Orthopedic Medicine: A Non-Surgical Approach to Chronic Pain Lawrence Cohen, M.D.

The Difference Between Prolotherapy, Trigger Points, and Acupuncture Marc Darrow, M.D.J.D.

Prolotherapy: Creating Inflammation in an Area that is Already Inflamed Marc Darrow, M.D.J.D.
Our bones and muscles are held together by the aptly named connective tissue. Connective tissues are ligaments, which connect bone to bone, and tendons, which connect the bones to muscles. It is also the fascia covering muscles and the joint capsule tissue.

Growth Factor Basis of Prolotherapy David Harris, M.D.
For many years, the positive effects of Prolotherapy were thought to be mainly based on the concept of inflammation and minor damage induced by the injection of irritating solutions, with subsequent healing of the injured areas. The benefit of solutions containing strong alcohol solutions, ground-up pumice stone, and other such recipes suggest that this is indeed one of the mechanisms of the strengthening and healing response seen with Prolotherapy.

What Does It Take To Heal Connective Tissue? Dave Harris, M.D.
Healing is a complex process. Many chemical reactions occur after an injury which together fight infection, clear away debris, and rebuild the damaged structure. Complex interplay occurs between nutrition, hormones, underlying disease, circulation, neurological connections, and many other factors. Many patients who do not heal their original injuries have deficiencies of some of these factors, or may have had such extensive injury that the result of healing was insufficient.

What Do You Mean The Prolotherapy Worked, I Still Have Pain! Ross Hauser, M.D.
A patient came in for his sixth Prolotherapy visit. The nurse told me the patient didn't feel much improvement in his knee pain, though he had already received five Prolotherapy treatments. 

Can Any Research Prove That Prolotherapy Works? Ross Hauser, M.D.
Before double-blinded studies, doctors would ask patients if they felt better. If patient after patient told the physician they felt better, than it was presumed and accepted that the therapy was effective. If it was a new therapy, then it was taught doctor to doctor and eventually it was taught in medical schools. If this was still the standard upon which medical therapies were judged, then clearly Prolotherapy would be taught in all the medical schools, but it is not. Why not?

What is the Proof Prolotherapy is Working? Ross Hauser, M.D.
This is a common question asked by people just about to receive Prolotherapy for the first time. Typically there are several variables that are looked at to make sure the Prolotherapy is achieving the results the person desires.

The Healing Powers of Prolotherapy Vladimir Djuric, M.D.

Why has your doctor never heard of Prolotherapy! Robert Filice, M.D.
Operations are what I do," Believe it or not, one of my recent new Prolotherapy patients was given the above quoted statement as an explanation for why the surgeon he was consulting did not offer any alternative treatments for his back pain.

How Chronic Non-Joint Pain is Helped by Prolotherapy K. Dean Reeves, M.D.

How Does Prolotherapy Work? Mark Wheaton, M.D.
Prolotherapy works on a very simple principle: injecting the prolotherapy solution at the sites of pain and weakness stimulates the body's own healing mechanism to repair and rebuild injured tissue into a stronger, more supportive, less painful tissue than it was before.

How Prolotherapy Helps Allen Thomashefsky, MD, PC 
Every joint in the body is held together by a ligament. When ligaments tear (we call this a "sprain") the joint can become unstable, like in a sprained ankle. When ligaments tear around a vertebrae (i.e. "whiplash"), the spine becomes unstable. You experience muscle spasm because the muscles are trying to make up for the weakness in the spine. 

Prolotherapy Stephen Blievernicht, MD FACS  

What is Prolotherapy-Indications and Contraindications K. Dean Reeves, M.D.
Prolotherapy is injection of any substance that acts as a ‘growth factor,’ that is, which promotes growth of normal cells, tissues, or organs. Injection of the hormone, erythropoietin, to produce red blood cells is widely used, and a number of other substances have been used for treatment of patients with various medical disorders. This discussion focuses on prolotherapy for musculoskeletal disorders, including arthritis and back pain. 

 


Prolotherapy Articles

A Rationale for Prolotherapy
Allen R. Banks, Ph.D.

Biological reconstruction - alternative to hip prosthesis
by Dr. William J. Faber

Case study: Sacro-Iliac Problems and the Benefit of Prolotherapy Over Time
William W. Frost Jr. M.D.

"Doc, do something--fast!"
by Katarzyna Wandycz

Injury to the Cervical Spine as a Cause of Headache
by Lester S. Blumenthal, MD

Ligament instability of knees: a new approach to treatment
Milne J. Ongley, Thomas A. Dorman, Bjorn C. Eek, David Lundgren, and Robert G. Klein

Non-Surgical Tendon, Ligament and Joint Reconstruction
by William J. Faber, D.O.

Proliferative Therapy
by Norman Zale

Prolotherapy Treatment of Low Back Pain and Sciatica
by Abraham Myers, M.D.

Resolve Joint Pain Without Surgery
Reconstructive Therapy Prevents Injury And Increases Endurance
by Dr. William J. Faber

Severe arthritis and failed back surgery of thirty years resolved by reconstruction therapy
by William J. Faber

Treatment of Consecutive Severe Fibromyalgia Patients with Prolotherapy
K Dean Reeves, MD

Sweet Relief (In adobe pdf format) BIOMECHANICS SEPTEMBER 2004
Injecting tendons with a dextrose solution to trigger an inflammatory reaction is just one way in which practitioners are using prolotherapy to target sprains and strains

Study Seeks Treatment To Keep Athletes in the Game BIOMECHANICS APRIL 2006
Osgood-Schlatter Disease and Prolotherapy


Medical Research Papers


Abstract of Prolotherapy research
These articles can be found at
http://drreeves.com/
Topol GA, Reeves KD, Hassanein K. Efficacy of Dextrose Prolotherapy in Elite Male Kicking-Sport Athletes With Chronic Groin Pain. Archives Phys Med Rehabil, 2005;86:697-702.

Reeves KD Hassanein K. Long term effects of dextrose prolotherapy for anterior cruciate ligament laxity: A prospective and consecutive patient study. Altern Ther Health Med (United States), May_Jun 2003, 9(3) p58-62.

Knee arthritis study Medline Reference: Reeves KD Hassanein K Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Alt Ther Hlth Med 2000;6(2):37-46

finger arthritis study Finger and Thumb Arthritis Study Using Dextrose Prolotherapy Medline Reference:Reeves KD Hassanein K Randomized prospective placebo controlled double blind study of dextrose prolotherapy for osteoarthritic thumbs and finger (DIP, PIP and Trapeziometacarpal) joints: Evidence of Clinical Efficacy. Jnl Alt Compl Med 2000;6(4):311-320.

Reeves KD, Treatment of Consecutive Severe Fibromyalgia Patients with Prolotherapy.
The Journal of Orthopaedic Medicine Vol 16 1994 No 3

Robert G. Schwartz, M.D. and Noreen Sagedy, M.D., Prolotherapy: A Literature Review and Retrospective Study The Journal of Neurological and Orthopedic Medicine and Surgery, Vol. 12. No. 3. 1991.

Treatment of Consecutive Severe Fibromyalgia Patients With Prolotherapy  
The Journal of Orthopaedic Medicine Vol 16 1994 No 3. A medical research article by K. Dean Reeves, M.D.

When Prolotherapy is Not Working
When Prolotherapy is Not Working (Multiple Articles)
Don't Prevent Prolotherapy From Working!
What Is The Proof Prolotherapy Is Working?
How to Optimize Response To Prolotherapy


Prolotherapy and the ACL
ACL Treatment Options Marc Darrow, M.D.
DO YOU REALLY NEED ACL SURGERY?  Ross Hauser, M.D.

Prolotherapy and Ankle Pain
CASE HISTORIES PROLOTHERAPY AND ANKLE PAIN
ANKLE FUSION AND PROLOTHERAPY Ross Hauser, M.D.

Prolotherapy and Arthritis
Prolotherapy Can Prevent the Development of Traumatic Arthritis Donna Alderman, D.O.
Prolotherapy: An Alternative to Arthritis Surgery Ross Hauser, M.D.

Prolotherapy and Back Disorder Articles
Prolotherapy and Spine Disorders Jay W. Nielsen, M.D.
Prolotherapy after Back Surgery Ross Hauser, M.D.
Prolotherapy and Scoliosis Ross Hauser, M.D.
Failed Back Surgery and Prolotherapy Ross Hauser, M.D.
Identifying Different Types of Back Pain Marc Darrow, M.D.
Low Back Pain and Prolotherapy Ross Hauser, M.D.
DEGENERATIVE DISC DISEASE AND BACK PAIN Ross Hauser, M.D.
Sciatica Marc Darrow, M.D.
Prolotherapy and Disc Problems Richard I. Gracer, M.D.
Complicated Disc Problem Marc Darrow, M.D.
Herniated Discs
Sacroiliac pain
Prolotherapy: An Alternative to Thoracic Spine Surgery Ross Hauser, M.D.
CASE HISTORIES FOR PROLOTHERAPY & BACK PAIN

Prolotherapy and Chronic Body Pain
Benign congenital hypermobility (BCH) Ross Hauser, M.D.

Prolotherapy and Collagen
Rebuilding Collagen: The Key to Prolotherapy Marc Darrow, M.D.

Prolotherapy and Elbow Pain
lnar collateral ligament sprain Ross Hauser, M.D.
Elbow Pain Ross Hauser, M.D.

Prolotherapy and Fibromyalgia
Prolotherapy and Fibromyalgia Jay W. Nielsen, M.D.
Prolotherapy and Fibromyalgia Robert Filice, M.D.
Treatment of Consecutive Severe Fibromyalgia Patients With Prolotherapy

Prolotherapy and Foot Pain
Foot Pain and Prolotherapy Ross Hauser, M.D.
Covering Tarsal Tunnel Syndrome and Morton's Neuroma Ross Hauser, M.D.
Chronic Foot Problems Ross Hauser, M.D.
CASE HISTORIES FOR PROLOTHERAPY & FOOT PAIN

Prolotherapy and Headache (Migraines)
Prolotherapy & Barre-Lieou Syndrome Ross Hauser, M.D.

Prolotherapy and Hip Pain
Biological Reconstruction - Alternatives to Hip Prosthesis William J. Faber, D.O.
Prolotherapy, Hip Pain & Snapping Hip Syndrome Ross Hauser, M.D.
Hip Pain and Prolotherapy Ross Hauser, M.D.
Other Hip Pain Articles

Prolotherapy and Inflammation
Prolotherapy: Creating Inflammation in an Area that is Already Inflamed
Can I Take Anti-Inflammatory Agents with Prolotherapy?
Diet and Inflammation
Creating Inflammation with Prolotherapy

Prolotherapy and Knee Pain
Knee Replacement and Prolotherapy Ross Hauser, M.D.
Knee Pain and Prolotherapy Ross Hauser, M.D.
Pes Anserinus Tendon Ross Hauser, M.D.
Knee Cap Pain,  Ross Hauser, M.D.
ACL Problems and Prolotherapy Marc Darrow, M.D.
ACL SURGERY Ross Hauser, M.D.
Prolotherapy and the Patella Ross Hauser, M.D.
PROLOTHERAPY AND THE SURGICALLY FAILED KNEE Ross Hauser, M.D.

Prolotherapy and Ligament Injury
The 7 No's of Ligament Injury Ross Hauser, M.D.
Prolotherapy and Ligament Pain Robert G. Schwartz MD

Prolotherapy and Neck Pain
Nerve Pain in the Neck and Shoulder Area Marc Darrow, M.D.
CASE HISTORIES PROLOTHERAPY & NECK PAIN

Prolotherapy and Pain Killers
Can I Take Anti-Inflammatory Agents With Prolotherapy? Ross Hauser, M.D.

Prolotherapy and Sports Injuries
Prolotherapy and Sports Injuries Ross Hauser, M.D.
Resolve Joint Pain Without Surgery William J. Faber, D.O.
CASE HISTORIES FOR PROLOTHERAPY & SPORTS INJURIES 

Prolotherapy and Shoulder Injuries
Prolotherapy and Shoulder Injuries Alvin Stein, M.D.
CASE HISTORIES PROLOTHERAPY & SHOULDER PAIN

Prolotherapy and TMJ
Prolotherapy as Treatment for TMJ Ross Hauser, M.D.
BARRE-LIEOU SYNDROME AND TMJ Marc Darrow, M.D.
CASE HISTORIES PROLOTHERAPY & TMJ
Jaw Pain Marc Darrow, M.D.

Prolotherapy and Whiplash Injuries
Prolotherapy for Whiplash, Chronic Neck Pain and Headaches Vladimir Djuric, M.D.
Whiplash Injury Marc Darrow, M.D.


Research Aritcles

In a study conducted in the 1950s by surgeon George Hackett, M.D., 1,600 patients with severe sacroiliac sprain were treated with prolotherapy injections. When the patients were examined by independent physicians two to 12 years later, 82% had remained free of pain or recurrences.(1) Dr. Hackett's experiments were repeated in 1983 and 1985 by the University of Iowa's Department of orthopaedic Research. Both studies found that the patients' tendons became more firmly attached to the bone and increased in strength and structure by 30%-40% above normal.(2)

In 1987, at the Sansum Medical Clinic of Santa Barbara, California, rheumatologist Robert Klein, M.D., and internist Thomas Dorman, M.D., conducted a double-blind study of 81 patients who suffered from continuous low-back pain for more than ten years. They found that 88% of the patients injected with a prolotherapy solution of dextrose, glycerine, and phenol demonstrated moderate to marked improvement.(3) A similar study, reported in the Journal of Spinal Disorders, showed an 80% improvement.(4) Both studies support Dr. Hackett's findings.

Studies conducted by Harold Walmer, D.O., of Elizabeth, Pennsylvania, have also shown that prolotherapy increases mechanical strength in ligaments and joints.(5) This may explain why so many patients with advanced degeneration of bones and soft tissues, or those who suffer from a wide range of musculoskeletal problems, have improved so dramatically when given prolotherapy injections.

Two placebo-controlled, blinded clinical trials of prolotherapy conducted in 2000 also attest to the therapy's effectiveness for treating osteoarthritic conditions. In the first study, 13 patients suffering from osteoarthritis in their knees showed significant improvement in knee pain, swelling, buckling, and joint flexibility after receiving prolotherapy treatments. Additionally, eight of the patients with loose anterior cruciate ligaments found that they tightened following prolotherapy injection alone.(6) The second study investigated the effectiveness of prolotherapy for treating osteoarthritis in finger and thumb joints. Upon completion of the study, prolotherapy was shown to produce significant improvement of pain and joint flexibility.(7)

A 16-year study conducted by Harold Wilkinson, M.D., former chair of neurosurgery at Massachusetts Medical Center, also supports prolotherapy's effectiveness. While patients typically require a series of prolotherapy injections before they experience complete elimination of their pain, Dr. Wilkinson reported that "a sizeable portion of people with unresolved chronic pain had more than a year's pain relief with only one injection."(8)

(1) Hackett, G. Ligament and Tendon Relaxation (skeletal disability) Treated by Prolotherapy (fibro-osseus proliferation). 3d ed. Springfield, IL: Charles C. Thomas, 1958.

(2) Maynard, J.; et al. "Morphological and Biochemical Effects of Sodium Morrhuate on Tendons." Journal of Orthopaedic Research 3 no. 2 (1985): 236-248.

(3) Ongley, M. J.; et al. "A New Approach to the Treatment of Chronic Low Back Pain." Lancet 2 no. 8551 (Jul 18, 1987): 143-146.

(4) Klein, R. G.; et al. "A Randomized Double-Blind Trial of Dextrose-Glycerine-Phenol Injections for Chronic, Low Back Pain." Journal of Spinal Disorders 6 no. 1 (Feb, 1993): 23-33.

(5) Liu, Y. K.; et al. "An In Situ Study of the Influence of a Sclerosing Solution in Rabbit Medial Collateral Ligaments and Its Junction Strength." Connective Tissue Research, 11 nos. 2 and 3 (1983): 95-102.

(6) Reeves, K. D.; Hassanein, K. "Randomized prospective double-blind placebo-controlled study of dextrose Prolotherapy for knee osteoarthritis with or without ACL laxity." Alternative Therapy Health Medicine 6, no 2 (2000): 37-46.

(7) Reeves, K.D.; Hassanein, K. "Randomized prospective placebo controlled double blind study of dextrose Prolotherapy for osteoarthritic thumbs and finger (DIP, PIP and Trapeziometacarpal) joints: Evidence of clinical Efficacy." Journal of Alternative and Complementary Medicine 6, no. 4 (2000): 311-320.

(8) Fletcher, D.F. "Regaining the Ability to Heal," Alternative Medicine 35 (May, 2000): 67.

The above article was taken in part from kalindra.com


Retrospective case series on patients with chronic spinal pain treated with dextrose prolotherapy

Advanced Spinal Care Centre, Calgary, Alberta, Canada. ahooper@ucalgary.ca

OBJECTIVES: To determine the clinical benefits of dextrose prolotherapy in patients with chronic spinal pain. DESIGN: Retrospective case series. SETTING/LOCATION: During the first 2 years at an outpatient prolotherapy clinic. SUBJECTS: One hundred and seventy-seven (177) consecutive patients with a history of chronic spinal pain completed prolotherapy treatment and were followed for a period ranging from 2 months to 2.5 years. INTERVENTIONS: Patients were treated with a proliferant solution containing 20% dextrose and 0.75% xylocaine. One half milliliter (0.5 mL) of proliferant was injected into the facet capsules of the cervical, thoracic, and lumbar spine, or combinations of the three areas. The iliolumbar and dorsal sacroiliac ligaments were also injected in patient with low back pain. Injections were typically done on a weekly basis for up to 3 weeks. A set of three injections was repeated in 1 month's time if needed. OUTCOME MEASURES: Level of pain, and improvement in activities of daily living were measured on a five-point scale. Improvement in ability to work was also assessed. RESULTS: Ninety-one percent (91.0%) of patients reported reduction in level of pain; 84.8% of patients reported improvement in activities of daily living, and 84.3% reported an improvement in ability to work. Women required on average, three more injections than men. Cervical spine response rates were lower than thoracic or lumbar spine. No complications from treatment were noted. CONCLUSIONS: Dextrose prolotherapy appears to be a safe and effective method for treating chronic spinal pain that merits further investigation. Future studies need to consider differences in gender response rates.

August 2004

Source PubMed


Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy.

Meadowbrook Rehabilitation Hospital, Gardner, Kansas, USA. dreeves1@kc.rr.com

OBJECTIVES: To determine the clinical benefit of dextrose prolotherapy (injection of growth factors or growth factor stimulators) in osteoarthritic finger joints. DESIGN: Prospective randomized double-blind placebo-controlled trial. SETTINGS/LOCATION: Outpatient physical medicine clinic. SUBJECTS: Six months of pain history was required in each joint studied as well as one of the following: grade 2 or 3 osteophyte, grade 2 or 3 joint narrowing, or grade 1 osteophyte plus grade 1 joint narrowing. Distal interphalangeal (DIP), proximal interphalangeal (PIP), and trapeziometacarpal (thumb CMC) joints were eligible. Thirteen patients (with seventy-four symptomatic osteoarthitic joints) received active treatment, and fourteen patients (with seventy-six symptomatic osteoarthritic joints) served as controls. INTERVENTION: One half milliliter (0.5 mL) of either 10% dextrose and 0.075% xylocaine in bacteriostatic water (active solution) or 0.075% xylocaine in bacteriostatic water (control solution) was injected on medial and lateral aspects of each affected joint. This was done at 0, 2, and 4 months with assessment at 6 months after first injection. OUTCOME MEASURES: One-hundred millimeter (100 mm) Visual Analogue Scale (VAS) for pain at rest, pain with joint movement and pain with grip, and goniometrically-measured joint flexion. RESULTS: Pain at rest and with grip improved more in the dextrose group but not significantly. Improvement in pain with movement of fingers improved significantly more in the dextrose group (42% versus 15% with a p value of .027). Flexion range of motion improved more in the dextrose group (p = .003). Side effects were minimal. CONCLUSION: Dextrose prolotherapy was clinically effective and safe in the treatment of pain with joint movement and range limitation in osteoarthritic finger joints.

August 2000

Source PubMed


A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain.

Klein RG, Eek BC, DeLong WB, Mooney V.

Sansum Medical Clinic, Department of Orthopaedic Medicine, Santa Barbara, CA 93102-1239.

This randomized clinical trial evaluated the efficacy of injections of a dextrose-glycerine-phenol connective tissue proliferant into the posterior ligaments, fascia, and joint capsules to treat chronic low back pain. Seventy-nine patients with chronic low back pain that had failed to respond to previous conservative care were randomly assigned to receive a double-blind series of six injections at weekly intervals of either Xylocaine/saline solution or Xylocaine/proliferant into the posterior sacroiliac and interspinous ligaments, fascia, and joint capsules of the low back from L4 to the sacrum. Patients were observed with a visual analog, disability, and pain grid scores, and with objective computerized triaxial tests of lumbar function for 6 months following conclusion of injections. Pretreatment imaging tests with either magnetic resonance imaging (MRI) or computed tomography (CT) scans were performed in all patients. Thirty of the 39 patients randomly assigned to the proliferant group achieved a 50% or greater diminution in pain or disability scores at 6 months compared to 21 of 40 in the group receiving lidocaine (p = 0.042). Subjective parameters measured at 6 months posttreatment improved (p < 0.001) overall in both the treatment and control group compared to baseline. Improvements in visual analog (p = 0.056), disability (p = 0.068), and pain grid scores (p = 0.025) were greater in the proliferant group. Objective testing of range of motion, isometric strength, and velocity of movement showed significant improvements in both groups following treatment but did not favor either group. The MRI and CT scans showed significant abnormalities in both groups, but these did not correlate with subjective complaints and were not predictive of response to treatment.

Publication Types:

February 1993

Source PubMed


Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial.

Yelland MJ, Glasziou PP, Bogduk N, Schluter PJ, McKernon M.

Centre for General Practice and School of Population Health, University of Queensland, Brisbane, Australia. myelland@bigpond.com

OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain. DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status. SETTING: General practice. PARTICIPANTS: One hundred ten participants with nonspecific low-back pain of average 14 years duration were randomized to have repeated prolotherapy (20% glucose/0.2% lignocaine) or normal saline injections into tender lumbo-pelvic ligaments and randomized to perform either flexion/extension exercises or normal activity over 6 months. MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months. RESULTS: Follow-up was achieved in 96% at 12 months and 80% at 2 years. Ligament injections, with exercises and with normal activity, resulted in significant and sustained reductions in pain and disability throughout the trial, but no attributable effect was found for prolotherapy injections over saline injections or for exercises over normal activity. At 12 months, the proportions achieving more than 50% reduction in pain from baseline by injection group were glucose-lignocaine: 0.46 versus saline: 0.36. By activity group these proportions were exercise: 0.41 versus normal activity: 0.39. Corresponding proportions for >50% reduction in disability were glucose-lignocaine: 0.42 versus saline 0.36 and exercise: 0.36 versus normal activity: 0.38. There were no between group differences in any of the above measures. CONCLUSIONS: In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises.

Aug 2004


Source PubMed


TITLE:
A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain.
AUTHORS:
Klein RG; Eek BC; DeLong WB; Mooney V
AUTHOR AFFILIATION:
Sansum Medical Clinic, Department of Orthopaedic Medicine, Santa Barbara, CA 93102-1239.
SOURCE:
J Spinal Disord 1993 Feb;6(1):23-33
CITATION IDS:
PMID: 8439713 UI: 93177083
ABSTRACT:
This randomized clinical trial evaluated the efficacy of injections of a dextrose-glycerine-phenol connective tissue proliferant into the posterior ligaments, fascia, and joint capsules to treat chronic low back pain. Seventy-nine patients with chronic low back pain that had failed to respond to previous conservative care were randomly assigned to receive a double-blind series of six injections at weekly intervals of either Xylocaine/saline solution or Xylocaine/proliferant into the posterior sacroiliac and interspinous ligaments, fascia, and joint capsules of the low back from L4 to the sacrum. Patients were observed with a visual analog, disability, and pain grid scores, and with objective computerized triaxial tests of lumbar function for 6 months following conclusion of injections. Pretreatment imaging tests with either magnetic resonance imaging (MRI) or computed tomography (CT) scans were performed in all patients. Thirty of the 39 patients randomly assigned to the proliferant group achieved a 50% or greater diminution in pain or disability scores at 6 months compared to 21 of 40 in the group receiving lidocaine (p = 0.042). Subjective parameters measured at 6 months posttreatment improved (p < 0.001) overall in both the treatment and control group compared to baseline. Improvements in visual analog (p =0.056), disability (p = 0.068), and pain grid scores (p = 0.025) were greater in the proliferant group. Objective testing of range of motion, isometric strength, and velocity of movement showed significant improvements in both groups following treatment but did not favor either group. The MRI and CT scans showed significant abnormalities in both groups, but these did not correlate with subjective complaints and were not predictive of response to treatment.

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