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K. Dean Reeves, M.D. Clinical Associate Professor Physical Medicine and Rehabilitation
Emphasis on Research in Use of Prolotherapy (Also called Regenerative Injection Therapy) ReevesOffice @ gmail.com Office Email DeanReevesMD @ gmail.com Personal email
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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.
Here is the abstract 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. 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. Key words: Osteoarthritis, knee, growth substances, proliferative, hypertonic, hypotonic. |
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1. DEX1 Reeves Et al 2000-1
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. 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. To open a PDF of
the study click here ->
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.