ALTERNATIVE THERAPIES, MARCH 2000, VOL. 6, NO. 2 Study of Dextrose Prolotherapy for Knee Osteoarthritis, RANDOMIZED PROSPECTIVE DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF DEXTROSE PROLOTHERAPY FOR KNEE OSTEOARTHRITIS WITH OR WITHOUT ACL LAXITY

Kenneth D. Reeves, MD, and Khatab Hassanein, PhDginal Kenneth D. Reeves is the section chief for Physical Medicine and Rehabilitation at Bethany Medical Center, Kansas City, Kan. Khatab Hassanein is professor and chairman for the Department of Biometry at the University of Kansas Medical Center, Kansas City, Kan.

OBJECTIVE: Determine the effects of dextrose prolotherapy on knee osteoarthritis with or without anterior cruciate ligament (ACL) laxity.
DESIGN: Prospective randomized double-blind placebo-controlled trial.
SETTING: Outpatient physical medicine clinic.
PATIENTS: OR OTHER PARTICIPANTS Six months or more of pain along with either grade 2 or more joint narrowing or grade 2 or more osteophytic change in any knee compartment. A total of 38 knees were completely void of cartilage radiographically in at least 1 compartment.
INTERVENTION: Three bimonthly injections of 9 cc of either 10% dextrose and .075% lidocaine in bacteriostatic water (active solution) versus an identical control solution absent 10% dextrose. The dextrose - treated joints then received 3 further bimonthly injections of10% dextrose in open-label fashion.
MAIN OUTCOME MEASURES: Visual analogue scale for pain and swelling, frequency of leg buckling, goniometrically measured flexion, radiographic measures of joint narrowing and osteophytosis, and KT1000-measured anterior displacement difference (ADD).
RESULTS ALL KNEES: Hotelling multivariate analysis of paired observations between 0 and 6 months for pain, swelling, buckling episodes,and knee flexion range re vealed significantly more benefit from the dextrose injection (P=.015). By 12 months (6 injections) the dextrose -treated knees improved in pain (44% decrease), swelling complaints( 63% decrease), knee buckling fre q u e n cy (85% decrease), and in flexion range (14 degree increase). Analysis of blinded radiographic readings of 0- and 12-month films revealed stability of all radiographic variables except for 2 variables which impro ved with statistical significance.(Lateral patellofemoral cartilage thickness [P=.019] and distal femur width in mm [P=.0 21]. Knees with ACL laxity: 6-month (3 injection) data revealed no significant impro vement. However, Hotelling multivariate analysis of paired values at 0 and 12 months for pain, swelling, joint flexion, and joint laxity in the dextrose - treated knees, revealed a statistically significant impro vement (P=.0 21 ). Individual paired t tests indicated that blinded measurement of goniometric knee flexion range impro ved by 12.8 degrees (P=.005), and ADD improved by 57% (P=.025). Eight out of 13 dextrose – treated knees with ACL laxity were no longer lax at the conclusion of 1 year.
CONCLUSION: Prolotherapy injection with 10% dextrose resulted in clinically and statistically significant improvements in knee osteoarthritis. Preliminary blinded radiographic readings (1- year films, with 3-year total follow-up period planned) demonstrated improvement in several measures of osteoarthritic severity. ACL laxity, when present in these osteoarthritic patients, improved.

LONG TERM EFFECTS OF DEXTROSE PROLOTHERAPY FOR ANTERIOR CRUCIATE LIGAMENT LAXITY

K. Dean Reeves, MD, and Khatab M. Hassanein, PhDinal research K. Dean Reeves is a clinical assistant professor in the Program of Integrative Medicine and Khatab M. Hassanein is professor and chairman of the Department of Biometry at the University of Kansas Medical Center in Kansas City, Kan.

CONTEXT: Use of dextrose prolotherapy. Prolotherapy is defined as injection that causes growth of normal cells or tissue.
OBJECTIVE: Determine the 1 and 3 year efficacy of dextrose injection prolotherapy on anterior cruciate ligament (ACL) laxity. After year 1, determine patient tolerance of a stronger dextrose concentration (25% versus 10%).
DESDIGN: Prospective consecutive patient trial.
SETTING: Outpatient physical medicine clinic.
PATIENT OR OTHER PARTICIPANTS: Eighteen patients with 6 months or more of knee pain plus ACL knee laxity. This laxity was defined by a KT1000 anterior displacement difference (ADD) of 2 mm or more.
INTERVENTION: Intraarticular injection of 6-9 cc of 10% dextrose at months 0, 2 ,4, 6, and 10. Injection with 6 cc of 25% dextrose at 12 months. Then, depending on patient preference, injection of either 10% or 25% dextrose every 2-4 months (based on patient preference) through 36 months.
MAIN OUTCOME MEASURES: Visual analogue scale (VAS) for pain at rest, pain on level surfaces, pain on stairs, and swelling. Goniometric flexion range of motion, and KT1000-measured ADD were also measured. All measurements were obtained at 0,6,12 and 36 months.
RESULTS: Two patients did not reach 6 month data collection, 1 of whom was diagnosed with disseminated cancer. The second was wheelchair-bound and found long-distance travel to the clinic problematic. Sixteen subjects were available for data analysis. KT1000 ADD. measurement indicated that 6 knees measured as normal (not loose) after 6 months, 9 measured as normal after 1 year (6 injections), and 10 measured as normal at 3 years. At the 3 year follow-up, pain at rest, pain with walking, and pain with stair use had improved by 45%, 43% , and 35% respectively, Individual paired t tests indicated subjective swelling improved 63% (P = .017), flexion range of motion improved by 10.5 degrees (P = .002), and KT1000 ADD improved by 71% (P = .002). Eleven out of 16 patients preferred 10% dextrose injection.
CONCLUSION: In patients with symptomatic anterior cruciate ligament laxity, intermittent dextrose injection resulted in clinically and statistically significant improvement in ACL laxity, pain, swelling, and knee range of motion. (Altern Ther Health Med. 9(3):52-56)

REPAIR OF A COMPLETE ANTERIOR CRUCIATE TEAR USING PROLOTHERAPY:
A CASE REPORT

Walter Grote, Rosa Delucia, Robert Waxman, Aleksandra Zgierska, John Wilson, David Rabago Sparta Medical Associates, Columbia New Jersey, USA Department of Family Medicine, University of Wisconsin, Madison, Wisconsin, USA Diagnostic Radiology Associates PA, Ridgewood, New Jersey, USA Int Musculoskelet Med. 2009 Dec

INTRODUCTION: Surgical reconstruction is considered definitive treatment for anterior cruciate ligament (ACL) tears but precise surgical indications are debated. Some patients are reluctant or inappropriate surgical candidates. Prolotherapy is a non-surgical injection therapy for chronic musculoskeletal pain and instability. This case report documents the non-surgical repair of a torn ACL using prolotherapy and at-home exercise.
CLINICAL PRESENATION AND INTERVENTION: An 18-year-old woman sustained a right knee injury during a downhill skiing accident. Magnetic resonance imaging (MRI) revealed a high-grade partial versus complete rupture; Lachman examination findings suggested a complete rupture. She deferred surgical treatment. At 21 weeks post-injury, with unstable gait, inability to climb stairs and more than 1-cm anterior drawer test, she consented to undergo prolotherapy injections. She received seven prolotherapy sessions over a 15-week period. At-home exercises were initiated at the third prolotherapy session.
RESULTS: The patient improved. Walking on flat ground improved 4 weeks after initiation of prolotherapy; she could ride a stationary bicycle for 30 min by 12 weeks. By 15 weeks, the patient had no instability climbing and descending stairs, the anterior drawer test was negative and MRI showed an intact ACL with fibrosis. Subsequently, she returned to full sport activity.
CONCLUSIONS: We document the non-surgical repair of a high-grade partial or complete ACL tear using prolotherapy and at-home exercise. Prolotherapy may be an alternative to surgery in carefully selected patients. This report is consistent with findings of recent pilot-level studies and suggests the need for rigorous clinical trials assessing prolotherapy as treatment for ligament and tendon injury in selected patients.