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      Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial

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          Abstract

          Background

          Osteoarthritis is a common degenerative disease. Prolotherapy is an alternative therapy used in multiple musculoskeletal disorders.

          Objective

          To compare the effectiveness of intra-articular dextrose injection versus peri-articular prolotherapy in patients with knee osteoarthritis (KOA).

          Methods

          Fifty-two adults with painful primary knee osteoarthritis for at least three months were randomized to intra- and peri-articular injection groups. Prolotherapy was done twice with two week intervals. The outcome measures included the Oxford Knee Scale (OKS), Western Ontario McMaster University Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS), which were obtained from patients before the first injection at the base line and after the second injection at the fourth and eighth weeks.

          Results

          There were no statistically significant differences between demographic characteristics; before the injection, pain intensity, OKS, and WOMAC scores were approximately equal between the two groups. After dextrose prolotherapy, VAS, OKS, and WOMAC scores improved from baseline through the fourth and eighth weeks in both groups without any superiority between the two methods of injections (p<0.001).

          Conclusion

          Dextrose prolotherapy either intra- or peri-articular injection resulted in significant improvement, so it could be an inexpensive and effective management of knee osteoarthritis.

          Trial registration

          The study protocol was registered as a clinical trial under registration ID of IRCT2016091229795N1 at the Iranian Registry of Clinical Trials ( http://www.irct.ir).

          Funding

          The authors received no financial support for the research, authorship, or publication of this article.

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          Most cited references23

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          The validation of visual analogue scales as ratio scale measures for chronic and experimental pain.

          Visual analogue scales (VAS) of sensory intensity and affective magnitude were validated as ratio scale measures for both chronic and experimental pain. Chronic pain patients and healthy volunteers made VAS sensory and affective responses to 6 noxious thermal stimuli (43, 45, 47, 48, 49 and 51 degrees C) applied for 5 sec to the forearm by a contact thermode. Sensory VAS and affective VAS responses to these temperatures yielded power functions with exponents 2.1 and 3.8, respectively; these functions were similar for pain patients and for volunteers. The power functions were predictive of estimated ratios of sensation or affect produced by pairs of standard temperatures (e.g. 47 and 49 degrees C), thereby providing direct evidence for ratio scaling properties of VAS. Vas sensory intensity responses to experimental pain, VAS sensory intensity responses to different levels of chronic pain, and direct temperature (experimental pain) matches to 3 levels of chronic pain were all internally consistent, thereby demonstrating the valid use of VAS for the measurement of and comparison between chronic pain and experimental heat pain.
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            A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain

            OBJECTIVE The aim of this study was to systematically review dextrose (d-glucose) prolotherapy efficacy in the treatment of chronic musculoskeletal pain. DATA SOURCES Electronic databases PubMed, Healthline, OmniMedicalSearch, Medscape, and EMBASE were searched from 1990 to January 2016. STUDY SELECTION Prospectively designed studies that used dextrose as the sole active prolotherapy constituent were selected. DATA EXTRACTION Two independent reviewers rated studies for quality of evidence using the Physiotherapy Evidence Database assessment scale for randomized controlled trials (RCTs) and the Downs and Black evaluation tool for non-RCTs, for level of evidence using a modified Sackett scale, and for clinically relevant pain score difference using minimal clinically important change criteria. Study population, methods, and results data were extracted and tabulated. DATA SYNTHESIS Fourteen RCTs, 1 case–control study, and 18 case series studies met the inclusion criteria and were evaluated. Pain conditions were clustered into tendinopathies, osteoarthritis (OA), spinal/pelvic, and myofascial pain. The RCTs were high-quality Level 1 evidence (Physiotherapy Evidence Database ≥8) and found dextrose injection superior to controls in Osgood–Schlatter disease, lateral epicondylitis of the elbow, traumatic rotator cuff injury, knee OA, finger OA, and myofascial pain; in biomechanical but not subjective measures in temporal mandibular joint; and comparable in a short-term RCT but superior in a long-term RCT in low back pain. Many observational studies were of high quality and reported consistent positive evidence in multiple studies of tendinopathies, knee OA, sacroiliac pain, and iliac crest pain that received RCT confirmation in separate studies. Eighteen studies combined patient self-rating (subjective) with psychometric, imaging, and/or biomechanical (objective) outcome measurement and found both positive subjective and objective outcomes in 16 studies and positive objective but not subjective outcomes in two studies. All 15 studies solely using subjective or psychometric measures reported positive findings. CONCLUSION Use of dextrose prolotherapy is supported for treatment of tendinopathies, knee and finger joint OA, and spinal/pelvic pain due to ligament dysfunction. Efficacy in acute pain, as first-line therapy, and in myofascial pain cannot be determined from the literature.
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              Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

              Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
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                Author and article information

                Journal
                Electron Physician
                Electron Physician
                Electronic physician
                Electronic Physician
                Electronic physician
                2008-5842
                November 2017
                25 November 2017
                : 9
                : 11
                : 5663-5669
                Affiliations
                [1 ]M.D. Physiatrist, Assistant Professor, Bone and Joint Diseases Research Center, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Shiraz University of Medical Science, Shiraz, Iran
                [2 ]M.D. Physical medicine and Rehabilitation Resident, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Shiraz University of Medical Science, Shiraz, Iran
                Author notes
                Corresponding author: Assistant Professor Dr. Hamid Reza Farpour, Bone and Joint Diseases Research Center, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Shiraz University of Medical Science, Shiraz, Iran. Tel: +98.9171179541, Fax: +98.7132329040, Email: farporh@ 123456sums.ac.ir
                Article
                epj-09-5663
                10.19082/5663
                5783111
                29403602
                3bb8fe82-9093-4846-b2b2-1021edf53b66
                © 2017 The Authors

                This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

                History
                : 18 March 2017
                : 10 June 2017
                Categories
                Original Article

                intra-articular injection,knee,osteoarthritis,prolotherapy

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