Dextrose and Morrhuate Sodium Injections (Prolotherapy) for Knee Osteoarthritis: A Prospective Open-Label Trial

Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Zgierska, Aleksandra; Fortney, Luke; Grettie, Jessica; Kijowski, Richard

doi:10.1089/acm.2013.0225

Cited by 25 publications

(24 citation statements)

References 22 publications

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“…Analysis of the WOMAC data suggests that prolotherapy improves knee-related QoL and is consistent with the findings of three prior trials. 141517 …”

Section: Discussionmentioning

confidence: 99%

“…17 Participants received either one of two similar prolotherapy protocols (“Prolotherapy”) or one of two control therapies (blinded saline injections or at-home exercise; “Control”). Participants enrolling in the clinical trials were serially offered MRI examinations at baseline and 52 weeks in addition to self-reported knee-specific assessment.…”

Section: Methodsmentioning

confidence: 99%

“…Adults 40 to 76 years old participating in one of two concurrent clinical trials 1517 were invited to participate. They were recruited from the University of Wisconsin Sports, Rehabilitation and Family Medicine clinics and the community.…”

Section: Eligibility Criteria and Participant Recruitmentmentioning

confidence: 99%

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Association Between Disease-Specific Quality of Life and Magnetic Resonance Imaging Outcomes in a Clinical Trial of Prolotherapy for Knee Osteoarthritis

Rabago¹,

Kijowski²,

Woods³

et al. 2013

Archives of Physical Medicine and Rehabilitation

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Objective To assess the relationship 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 compared to blinded saline injections and at-home exercise but the mechanism of action is unknown. Design Two-arm (Prolotherapy, Control), partially blinded, controlled trial. Setting Outpatient. Participants 37 adults with ≥3 months of symptomatic KOA. Intervention Prolotherapy: 5 monthly injection sessions; Control: blinded saline injections or at-home exercise. Outcome Measures Primary: KOA-specific QoL scores (baseline, 5, 9, 12, 26, 52 weeks; Western Ontario McMaster University Osteoarthritis Index, WOMAC). Secondary: KOA-specific pain, stiffness, function (WOMAC subscales), magnetic resonance imaging (MRI)-assessed CV (baseline, 52 weeks). Results Knee-specific QoL improvement among Prolotherapy participants exceeded that of Controls (17.6±3.2 versus 8.6±5.0 points, p=0.05) at 52 weeks. Both groups lost CV over time (p<0.05); no between-group differences were noted (p=0.98). 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, 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<0.05). Conclusions Prolotherapy resulted in safe, substantial improvement in KOA-specific QoL compared to Control over 52-weeks. Among prolotherapy participants, but not Controls, MRI-assessed CV change (CV stability) predicted pain severity score change, suggesting prolotherapy may have pain-specific disease-modifying effect. Further research is warranted.

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“…Analysis of the WOMAC data suggests that prolotherapy improves knee-related QoL and is consistent with the findings of three prior trials. 141517 …”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Association Between Disease-Specific Quality of Life and Magnetic Resonance Imaging Outcomes in a Clinical Trial of Prolotherapy for Knee Osteoarthritis

Rabago¹,

Kijowski²,

Woods³

et al. 2013

Archives of Physical Medicine and Rehabilitation

Self Cite

View full text Add to dashboard Cite

show abstract

“…We excluded one single-arm trial, due to lack of quantitative pain evaluation in patients with patellar chondro-arthropathy,18 one RCT comparing single injection of dextrose with erythropoietin,19 one RCT targeting nonspecific chronic low back pain without definite radiologic evidence of lumbar spine osteoarthritis,20 and two observational studies analyzing data from a published RCT exploring knee osteoarthritis 21,22. The final meta-analysis included one single-arm follow-up trial23 and five RCTs,7,8,24–26 four of which probed knee osteoarthri tis7,23,24,26 and two of which examined hand osteoarthritis 8,25.…”

Section: Resultsmentioning

confidence: 99%

Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis

Hung

Hsiao

Chang

et al. 2016

JPR

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BackgroundIncreasing evidence has supported the use of dextrose prolotherapy for patients with osteoarthritis. However, the real benefits may be affected by differences in injection protocols, comparative regimens, and evaluation scales.MethodsPubMed and Scopus were searched from the earliest record until February 2016. One single-arm study and five randomized controlled trials were included, comprising 326 participants. We estimated the effect sizes of pain reduction before and after serial dextrose injections and compared the values between dextrose prolotherapy, comparative regimens, and exercise 6 months after the initial injection.ResultsRegarding the treatment arm using dextrose prolotherapy, the effect sizes compared with baseline were 0.65 (95% confidence interval [CI], 0.14–1.17), 0.84 (95% CI, 0.40–1.27), 0.85 (95% CI, 0.60–1.10), and 0.87 (95% CI, 0.53–1.21) after the first, second, third, and fourth or more injections, respectively. The overall effect of dextrose was better than control injections (effect size, 0.36; 95% CI, 0.10–0.63). Dextrose prolotherapy had a superior effect compared with local anesthesia (effect size, 0.38; 95% CI, 0.07–0.70) and exercise (effect size, 0.71; 95% CI, 0.30–1.11). There was an insignificant advantage of dextrose over corticosteroids (effect size, 0.31; 95% CI, –0.18 to 0.80) which was only estimated from one study.ConclusionDextrose injections decreased pain in osteoarthritis patients but did not exhibit a positive dose–response relationship following serial injections. Dextrose prolotherapy was found to provide a better therapeutic effect than exercise, local anesthetics, and probably corticosteroids when patients were retested 6 months following the initial injection.

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“…Prolotherapy from "proliferation therapy" is an old and badly defined concept associated to the local effects induced by some molecules (sclerosing agents) injected in chronically injured musculoskeletal tissue including ligament, tendon and joint (117). Hypertonic dextrose is the most commonly used prolotherapy injectant.…”

Section: Other Ia Compounds Used For Oa Treatmentmentioning

confidence: 99%

An update on the up and coming therapies to treat osteoarthritis, a multifaceted disease

Roman‐Blas

Bizzi

Largo

et al. 2016

Expert Opinion on Pharmacotherapy

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Despite the renewed interest in the search of new compounds for treatment of OA, results have been limited. Novel systemic and IA administered agents are in active development. IA drug administration is particularly an attractive approach because can diminish some of the severe side effects associated with systemic drugs. Indeed, one of the most promising fields for pharmacology innovation in OA is joint injected therapy, as suggested by preliminary data from recent studies using IA sprifermin (rhFGF-18), mesenchymal stem cells or TGF-B1 transduced allogenic chondrocytes. Last, the effort to develop new drugs must be accompanied by the interest for establishing well-defined phenotypes, and only then, a more tailored therapy should be practiced in OA.

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Dextrose and Morrhuate Sodium Injections (Prolotherapy) for Knee Osteoarthritis: A Prospective Open-Label Trial

Abstract: 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.

Cited by 25 publications

References 22 publications

Association Between Disease-Specific Quality of Life and Magnetic Resonance Imaging Outcomes in a Clinical Trial of Prolotherapy for Knee Osteoarthritis

Association Between Disease-Specific Quality of Life and Magnetic Resonance Imaging Outcomes in a Clinical Trial of Prolotherapy for Knee Osteoarthritis

Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis

An update on the up and coming therapies to treat osteoarthritis, a multifaceted disease

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