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Objectives: This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status., Design: This was a prospective three-arm uncontrolled study with 1-year follow-up., Setting: The setting was outpatient., Participants: The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined)., Intervention: The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach., Outcome Measures: The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction., Results: The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events., Conclusions: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

Objective: To assess the relation between knee osteoarthritis (KOA)-specific quality of life (QOL) and intra-articular cartilage volume (CV) in participants treated with prolotherapy. KOA is characterized by CV loss and multifactorial pain. Prolotherapy is an injection therapy reported to improve KOA-related QOL to a greater extent than blinded saline injections and at-home exercise, but its mechanism of action is unclear., Design: Two-arm (prolotherapy, control), partially blinded, controlled trial., Setting: Outpatient., Participants: Adults with ≥3 months of symptomatic KOA (N=37)., Interventions: Prolotherapy: 5 monthly injection sessions;, Control: blinded saline injections or at-home exercise., Main Outcome Measures: Primary: KOA-specific QOL scores (baseline, 5, 9, 12, 26, and 52wk; Western Ontario and McMaster University Osteoarthritis Index). Secondary: KOA-specific pain, stiffness, function (Western Ontario McMaster University Osteoarthritis Index subscales), and magnetic resonance imaging-assessed CV (baseline, 52wk)., Results: Knee-specific QOL improvement among prolotherapy participants exceeded that among controls (17.6±3.2 points vs 8.6±5.0 points; P=.05) at 52 weeks. Both groups lost CV over time (P<.05); no between-group differences were noted (P=.98). While prolotherapy participants lost CV at varying rates, those who lost the least CV ("stable CV") had the greatest improvement in pain scores. Among prolotherapy participants, but not control participants, the change in CV and the change in pain (but not stiffness or function) scores were correlated; each 1% CV loss was associated with 2.7% less improvement in pain score (P<.05)., Conclusions: Prolotherapy resulted in safe, substantial improvement in KOA-specific QOL compared with control over 52 weeks. Among prolotherapy participants, but not controls, magnetic resonance imaging-assessed CV change (CV stability) predicted pain severity score change, suggesting that prolotherapy may have a pain-specific disease-modifying effect. Further research is warranted., (Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to determine whether prolotherapy, an injection-based complementary treatment for chronic musculoskeletal conditions, improves pain, stiffness, and function in adults with symptomatic knee osteoarthritis (KOA) compared to baseline status., Design: This was a prospective, uncontrolled study with 1-year follow-up., Setting: The study was conducted in an outpatient setting., Participants: Adults with at least 3 months of symptomatic KOA, recruited from clinical and community settings, participated in the study., Interventions: Participants received extra-articular injections of 15% dextrose and intra-articular prolotherapy injections of 25% dextrose at 1, 5, and 9 weeks, with as-needed treatments at weeks 13 and 17., Outcome Measures: Primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). Secondary outcome measure was the validated Knee Pain Scale (KPS). Tertiary outcome measure was procedure-related pain severity and participant satisfaction., Results: Thirty-six (36) participants (60 ± 8.7 years old, 21 female) with moderate-to-severe KOA received an average of 4.3 ± 0.7 prolotherapy injection sessions over a 17-week treatment period and reported progressively improved scores during the 52-week study on WOMAC and KPS measures. Participants reported overall WOMAC score improvement 4 weeks after the first injection session (7.6 ± 2.4 points, 17.2%), and continued to improve through the 52-week follow-up (15.9 ± 2.5 points, p<0.001, 36.1%). KPS scores improved in both injected (p<0.001) and uninjected knees (p<0.05). Prescribed low-dose opioid analgesia effectively treated procedure-related pain. Satisfaction was high and there were no adverse events. Female gender, age 46-65 years old, and body-mass index of 25 kg/m(2) or less were associated with greater improvement on the WOMAC instrument., Conclusions: In adults with moderate to severe KOA, dextrose prolotherapy may result in safe, significant, sustained improvement of knee pain, function, and stiffness scores. Randomized multidisciplinary effectiveness trials including evaluation of potential disease modification are warranted to further assess the effects of prolotherapy for KOA.