Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without acl laxity.

Context – Use of prolotherapy (injection of growth factors or growth factor stimulators).

O b j e c t i ve – Determine the effects of dextrose pro l o t h e rapy on knee osteoarthritis with or without anterior cruciate ligament (ACL) laxity.

Design – Pro s p e c t i ve 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 ra d i o g raphically in at least 1 compartment.

Intervention – Three bimonthly injections of 9 cc of either 10% dext rose 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, ra d i o g raphic 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 dext rose injection (P=.015). By 12 months (6 injections) the dextrose – t reated knees impro ved 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 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 re vealed no significant impro vement. Ho w e ve r, Hotelling multivariate analysis of paired values at 0 and 12 months for pain, swelling, joint flexion, and joint laxity in the dextro s e – t re a t e d knees, re vealed 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 impro ved by 57% (P=.025). Eight out of 13 dextro s e – t re a t e d 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 impro vements in knee osteoarthritis. Pre l i m i n a ry blinded ra d i o g raphic readings (1- y e a r films, with 3-year total follow-up period planned) demonstra t e d improvement in several measures of osteoarthritic severity. ACL laxity, when present in these osteoarthritic patients, impro ved. (Al t e r n Ther Health Med.