Prolotherapy Peer-Reviewed and Scientific Articles and Abstracts Part 2
March 17, 2011 by Dr. Marc Darrow, M.D.
Filed under Prolotherapy Medical Literature
Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity.
Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med 2000 Mar;6(2):68-74, 77-80.
CONTEXT: Use of prolotherapy (injection of growth factors or growth factor stimulators). 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 of 10% 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 revealed 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 frequency (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 improved with statistical significance. (Lateral patellofemoral cartilage thickness [P = .019] and distal femur width in mm [P = .021]. Knees with ACL laxity: 6-month (3 injection) data revealed no significant improvement. 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 improvement (P = .021). Individual paired t tests indicated that blinded measurement of goniometric knee flexion range improved 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 Injections 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 osteoarthritis severity. ACL laxity, when present in these osteoarthritic patients, improved.
Long-term effects of dextrose prolotherapy injections for anterior cruciate ligament laxity
Reeves KD, Hassanein KM. Long-term effects of dextrose prolotherapy for anterior cruciate ligament laxity. Altern Ther Health Med. 2003 May-Jun;9(3):58-62.
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%).
DESIGN: Prospective consecutive patient trial. SETTING: Outpatient physical medicine clinic. PATIENTS 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.
