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      Ultrasound-Guided Injection of High Molecular Weight Hyaluronic Acid versus Corticosteroid in Management of Plantar Fasciitis: A 24-Week Randomized Clinical Trial

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          Background and Aims

          Plantar fasciitis (PF) is the leading cause of heel pain in adults. This study was designed to evaluate the effect of hyaluronic acid (HA) injection in reducing the symptoms of PF, compared with corticosteroid (CS) injection as a conventional treatment.


          In this triple-blind, randomized, clinical trial, 75 patients who had the symptoms of PF for at least 3 months were randomly divided into two groups of 38 and 37 individuals. Then, each patient received either a single injection of high molecular weight (>2000 kDa) HA (1 mL HA 20 mg + 1 mL lidocaine 2%) or CS (1 mL methylprednisolone 40 mg + 1 mL lidocaine 2%) under the ultrasonography (US) guidance. Visual analog scale (VAS), foot ankle ability index (FAAI), pressure pain threshold (PPT), functional foot index (FFI), and plantar fascia thickness (PFT) were measured using US at baseline, 6 weeks and 24 weeks after the injection. Eventually, at the end of the treatment period, the patients’ satisfaction was measured. Intention to treat analysis was used to assess the results.


          After 24 weeks of follow-up, results from 60 subjects were fully obtained; however, results of 73 patients included into intention to treat analysis in the sixth-week follow-up. In both groups, VAS, PFT and FFI decreased, while FAAI and PPT increased significantly ( P <0.001). At the baseline and at the 24th-week, no significant difference between the two groups was observed in any of the variables. However, a comparison between the baseline and the sixth-week results shows a prominent decrease in PPT and PFT in the CS group compared to the HA group ( P = 0.004 and P = 0.011). Finally, there were no statistical differences between the two groups in treatment satisfaction ( P = 0.618).


          Both CS and HA were effective modalities for PF and can improve pain and function with no superiority in 24th-week follow-ups, although CS seems to have a faster trend of improvement in the short term.

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          Most cited references 45

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          Hyaluronan (hyaluronic acid) is a high-molecular-mass polysaccharide found in the extracellular matrix, especially of soft connective tissues. It is synthesized in the plasma membrane of fibroblasts and other cells by addition of sugars to the reducing end of the polymer, whereas the nonreducing end protrudes into the pericellular space. The polysaccharide is catabolized locally or carried by lymph to lymph nodes or the general circulation, from where it is cleared by the endothelial cells of the liver sinusoids. The overall turnover rate is surprisingly rapid for a connective tissue matrix component (t1/2 0.5 to a few days). Hyaluronan has been assigned various physiological functions in the intercellular matrix, e.g., in water and plasma protein homeostasis. Hyaluronan production increases in proliferating cells and the polymer may play a role in mitosis. Extensive hyaluronidase-sensitive coats have been identified around mesenchymal cells. They are either anchored firmly in the plasma membrane or bound via hyaluronan-specific binding proteins (receptors). Such receptors have now been identified on many different cells, e.g., the lymphocyte homing receptor CD 44. Interaction between a hyaluronan receptor and extracellular polysaccharide has been connected with locomotion and cell migration. Hyaluronan seems to play an important role during development and differentiation and has other cell regulatory activities. Hyaluronan has also been recognized in clinical medicine. A concentrated solution of hyaluronan (10 mg/ml) has, through its tissue protective and rheological properties, become a device in ophthalmic surgery. Analysis of serum hyaluronan is promising in the diagnosis of liver disease and various inflammatory conditions, e.g., rheumatoid arthritis. Interstitial edema caused by accumulation of hyaluronan may cause dysfunction in various organs.
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            Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters.

            To evaluate interrater reliability using 5 newly trained observers in the assessment of pressure pain threshold (PPT) using a fixed-angle algometer. The study design comprised 2 phases. Phase 1: 5 undergraduate physical therapists were trained in algometry at a predefined angle, at a rate of 5 Newtons (N)/s, to the first dorsal interosseous muscle. Each observer then underwent a competency test of the application speed. The aim was to achieve repeated applications at 5 N/s without visual feedback from the algometer. Phase 2: the 5 observers measured PPT of 13 healthy volunteers, at the first dorsal interosseous muscle. The sequence of observer measurements for each participant was randomized. Mean PPT values for each observer were analyzed using repeated measures analysis of variance, intraclass correlation coefficient (ICC2,1), and standard error of measurement, with 95% confidence intervals (CIs). No significant differences between observers' mean values were found (P=0.094), suggesting no bias. The ICC was 0.91 (95% CI 0.82, 0.97). The standard error of measurement value was 6.27 N/cm (95% CI 5.35, 7.59). Differences in PPT measurements of more than 17.39 N/cm (1.77 kg/cm) are likely to exceed the magnitude of measurement error, and could be used to indicate true change. This margin of error is, however, somewhat larger than a previously proposed minimum clinically important difference in PPT of 14.71 N/cm (1.5 kg/cm). This study provides new evidence that trained observers can apply an algometer at a consistent rate and provide highly reliable measures of PPT in healthy humans, when PPT is calculated as the mean of 3 trials.
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              Complications of plantar fascia rupture associated with corticosteroid injection.

               J Beskin,  J Acevedo (1998)
              From 1992 to 1995, 765 patients with a clinical diagnosis of plantar fasciitis were evaluated by one of the authors. Fifty-one patients were diagnosed with plantar fascia rupture, and 44 of these ruptures were associated with corticosteroid injection. The authors injected 122 of the 765 patients, resulting in 12 of the 44 plantar fascia ruptures. Subjective and objective evaluations were conducted through chart and radiographic review. Thirty-nine of these patients were evaluated at an average 27-month follow-up. Thirty patients (68%) reported a sudden onset of tearing at the heel, and 14 (32%) had a gradual onset of symptoms. In most cases the original heel pain was relieved by rupture. However, these patients subsequently developed new problems including longitudinal arch strain, lateral and dorsal midfoot strain, lateral plantar nerve dysfunction, stress fracture, hammertoe deformity, swelling, and/or antalgia. All patients exhibited diminished tension of the plantar fascia upon examination by the stretch test. Comparison of calcaneal pitch angles in the affected and uninvolved foot showed a statistically significant difference of 3.7 degrees (P = 0.0001). Treatment included NSAIDs, rest or cross-training, stretching, orthotics, and boot-brace immobilization. At an average 27-month follow-up, 50% had good/excellent scores and 50% had fair/poor scores. Recovery time was varied. Ten feet were asymptomatic by 6 months post rupture, four feet by 12 months post rupture, and 26 feet remained symptomatic 1 year post rupture. Our findings demonstrate that plantar fascia rupture after corticosteroid injection may result in long-term sequelae that are difficult to resolve.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                14 January 2020
                : 13
                : 109-121
                [1 ]Clinical Research Development Center, Shahid Modarres Hospital , Tehran, Iran
                [2 ]Physical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences , Tehran, Iran
                [3 ]Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran, Iran
                Author notes
                Correspondence: Mahtab Darvish Physical Medicine and Rehabilitation Research Center, Shahid Modarres Hospital , Saadat Abad St., Yadegare Imam Highway, Tehran1998734383, IranTel/Fax +982122832343 Email mahtab.darvish@sbmu.ac.ir
                Hadi Esmaily Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Niayesh Highway, Valiasr Ave, Tehran6153-14155, IranTel +98 9121579064 Email Esmaily_hadi@sbmu.ac.ir
                © 2020 Raeissadat et al.

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                Page count
                Figures: 7, Tables: 4, References: 56, Pages: 13
                Clinical Trial Report


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