Randomized controlled trial for the treatment of chronic dorsal wrist pain with dextrose prolotherapy

摘要

Objective: To compare the results of treating chronic dorsal wrist pain with lidocaine (placebo) versusnlidocaine/dextrose (dextrose) injection.nMethods: Of the 98 patients screened, 39 were entered into the trial. Patients were assessed at baseline, 3nand 12 months post-treatment with Patient RatedWrist Evaluation (PRWE), range of motion, and grip strength.nInjections were completed monthly, up to a total of six treatments. Injections to the periscaphoid, andnperilunate ligaments, using a peppering technique, for a total of 1 ml at each site, with 1% lidocaine or anmixture of 0.60% lidocaine and 20% dextrose were given. Blinding was done at all stages of the trial fornthe patient, study coordinator, prolotherapist, patient outcome measures, and statistician.nResults: Twenty patients were assigned to the dextrose solution, and 19 patients were assigned to the placebonsolution. There was no statistically significant difference in the PRWE change scores between the dextrosengroup and the placebo group (P=0.483) at 3 months. At 12 months, the adjusted mean reduction in scoresnwas 31.0 for patients treated with dextrose, and 20.9 for those treated with the placebo solution. Thisndifference of 10.1 was a statistically significant effect, with a P-value of 0.043, but is smaller than the minimalnclinically important difference of 20 points defined by MacDermid et al. Grip strength and range of motionnshowed no statistically significant difference between the two treatment groups throughout study.nConclusions: Due to the large treatment effect in the placebo group, it was very unlikely with further enrollmentnthat a clinically significant change of greater than 20 on the PRWE would be found and the trial wasndiscontinued. The efficacy of prolotherapy injections with an active agent relative to a control solution,ntherefore, has not yet been established. Further studies are needed to compare a treatment group with annon-injection group, subcutaneous needle injection, or dry needling.