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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.
Dr. Reeves' Notes: In this study of patients with advanced knee osteoarthritis (bone on bone on skier's view in 35/111 knees), the 10% dextrose injection was superior to the hypotonic lidocaine solution injection, (p =0.15) showing better results in walking pain (35%), subjective swelling(45%), a 67% reduction in knee buckling episodes, and a substantial (13 degree) improvement in active knee bending ability. It is important to note that the control solution (0.1% lidocaine) was not likely a placebo because injection resulted in 26% improvement in walking pain and a 7.7 degree increase in goniometrically measured knee range of motion. Hypotonic solutions have effects on growth factors too, and tonicity of control solutions should be considered in study designs.
Subjects had chronic knee pain (6 months minimum with an average of 8 years). The average cartilage thickness was only 3 mm on skier's view (medial compartment primarily) The treatment consisted of 3 injections of 9 cc of 10% dextrose solution over 6 months versus an identical volume hypotonic lidocaine solution.
Note the "control" solution, chosen for maximum safety in human subject committee submission was bacteriostatic water with low dose (0.1%) lidocaine). This calculated osmolarity is 105 mOsm, and less than 250 mOsm we now know affects growth factors and may not be a placebo.
The abstract of the study on Osteoarthritis of Knee DEX is available here, with a copy below.
Context: Prolotherapy in arthritis
Objective: Determine the effects of injection of hypertonic dextrose on knee osteoarthritis.
Design: Prospective randomized double-blind controlled trial.
Setting: Outpatient physical medicine clinic. Patients or other participants: 6 months or more of pain and either grade 2 or 3 joint narrowing or grade 2 or 3 osteophyte in any knee compartment.
Intervention: Three bimonthly injections of 9 c.c. of either 10% Dextrose and .075% Xylocaine 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: 100 mm visual analogue scale (V.A.S.) for rest pain, walking pain, standing pain, and swelling. The number of buckling episodes were estimated over the preceding two months. Flexion was goniometrically measured in blinded fashion. Radiographic measures of cartilage thickness, osteophyte grade, and hypertrophic change were obtained.
Results: The magnitude of improvement in subjective and objective measures in control-treated knees suggested that the control solution (water) may have had more than a placebo effect. Nevertheless, Hotelling multivariate analysis of paired observations between 0 and 6 months for pain, swelling, buckling episodes, and flexion revealed significantly more benefit from the dextrose injection, (p = .015 ). By 12 months (6 injections) the dextrose-treated knees improved in pain, swelling, knee buckling and flexion by 44%, 63%, 85% and 14 degrees respectively. Analysis of blinded radiographic readings of 0 and 12 month films revealed a statistically significant improvement in radiographic measures of osteoarthritis from 0 to 12 months.
Conclusion: Prolotherapy (Injection to produce a growth or repair response in body cells) utilizing sub-inflammatory levels of dextrose (10%) solution, when performed bimonthly, resulted in clinically and statistically significant improvements in knee osteoarthritis. Blinded radiographic follow up at 1 year suggests improvement in several measures of osteoarthritic severity.