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- Atroshi, Isam, et al.
(author)
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Methylprednisolone Injections for the Carpal Tunnel Syndrome A Randomized, Placebo-Controlled Trial
- 2013
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In: Annals of Internal Medicine. - : American College of Physicians. - 0003-4819. ; 159:5, s. 309-309
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Journal article (peer-reviewed)abstract
- Background: Steroid injections are used in idiopathic carpal tunnel syndrome (CTS), but evidence of efficacy beyond 1 month is lacking. Objective: To assess the efficacy of local methylprednisolone injections in CTS. Design: Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT00806871) Setting: Regional referral orthopedic department in Sweden. Patients: Patients aged 18 to 70 years with CTS but no previous steroid injections. Intervention: Three groups (37 patients each) received 80 mg of methylprednisolone, 40 mg of methylprednisolone, or placebo. The patients and treating surgeons were blinded. Measurements: Primary end points were the change in CTS symptom severity scores at 10 weeks (range, 1 to 5) and rate of surgery at 1 year. Three patients had missing 10-week data. All patients had 1-year data. Results: Improvement in CTS symptom severity scores at 10 weeks was greater in patients who received 80 mg of methylprednisolone and 40 mg of methylprednisolone than in those who received placebo (difference in change from baseline, -0.64 [95% CI, -1.06 to -0.21; P = 0.003] and -0.88 [CI, -1.30 to -0.46; P < 0.001], respectively), but there were no significant differences at 1 year. The 1-year rates of surgery were 73%, 81%, and 92% in the 80-mg methylprednisolone, 40-mg methylprednisolone, and placebo groups, respectively. Compared with patients who received placebo, those who received 80 mg of methylprednisolone were less likely to have surgery (odds ratio, 0.24 [CI, 0.06 to 0.95]; P = 0.042). With time to surgery incorporated, both the 80- and 40-mg methylprednisolone groups had lower likelihood of surgery (hazard ratio, 0.46 [CI, 0.27 to 0.77; P = 0.003] and 0.57 [CI, 0.35 to 0.94; P = 0.026], respectively). Limitation: The study was conducted at 1 center, and wrist splinting had previously failed for all patients. Conclusion: Methylprednisolone injections for CTS have significant benefits in relieving symptoms at 10 weeks and reducing the rate of surgery 1 year after treatment, but 3 out of 4 patients had surgery within 1 year.
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- Atroshi, Isam, et al.
(author)
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Open compared with 2-portal endoscopic carpal tunnel release: a 5-year follow-up of a randomized controlled trial.
- 2009
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In: The Journal of Hand Surgery. - : Elsevier BV. - 1531-6564 .- 0363-5023. ; 34:2, s. 266-272
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Journal article (peer-reviewed)abstract
- PURPOSE: The purpose of this investigation was to extend the previously reported short-term randomized trial of open and endoscopic carpal tunnel release in patients with carpal tunnel syndrome (CTS) to compare outcomes 5 years after surgery. METHODS: In a single-center randomized controlled trial, 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS were randomized immediately before surgery to open or 2-portal endoscopic release. The outcome measures included the validated CTS questionnaire's symptom severity and functional status scales (scored from 1 to 5) completed at baseline and 1 year postoperatively. At the extended follow-up of the trial 5 years after surgery, 2 patients had died and the other 126 participants (63 patients in each group) completed the CTS questionnaire. RESULTS: At the 5-year follow-up no difference between the groups was found in the CTS symptom severity score. The mean (SD) score in the open group was 1.42 (0.7) and in the endoscopic group was 1.45 (0.7), and the mean difference in score change from baseline was 0.03 (95% confidence interval, -0.21 to 0.27). Between 1 year and 5 years postoperatively, the CTS symptom severity score had deteriorated by at least 0.4 point in 9 patients in the open group and in 10 patients in the endoscopic group. The mean (SD) CTS functional status score was 1.29 (0.5) in the open group and 1.30 (0.5) in the endoscopic group. At 5 years, 11 patients in the open group and 10 patients in the endoscopic group reported persistent pain in the scar or proximal palm. Three patients in each group had repeat surgery on the operated hand because of persistent or recurrent symptoms. CONCLUSIONS: The improvements in symptoms of CTS and hand-related disability 5 years after open and 2-portal endoscopic carpal tunnel release were equivalent. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.
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| 4. |
- Atroshi, Isam, et al.
(author)
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Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial.
- 2006
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In: BMJ. - 0959-8138. ; 332(7556):1473, s. 1473-1476
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Journal article (peer-reviewed)abstract
- Objectives To compare endoscopic and open carpal tunnel release surgery among employed patients with carpal tunnel syndrome. Design and setting Randomised controlled trial at a single orthopaedic department. Participants 128 employed patients aged 25-60 years with clinically diagnosed and electrophysiologically confirmed idiopathic carpal tunnel syndrome. Main outcome measures The primary outcome was severity of postoperative pain in the scar or proximal palm and the degree to which pain or tenderness limits activities, each rated on a 4 point scale, transformed into a combined score of 0 (none) to 100 (severe pain or tenderness causing severe activity limitation). The secondary outcomes were length of postoperative work absence, severity of symptoms of carpal tunnel syndrome and functional status scores, SF-12 quality of life score, and hand sensation and strength (blinded examiner); follow-up at three and six weeks and three and 12 months. Results 63 patients were allocated to endoscopic surgery and 65 patients to open surgery, with no withdrawals or dropouts. Pain hi the scar or proximal palm was less prevalent or severe after endoscopic surgery than after open surgery but die differences were generally small. At three months, pain in the scar or palm was reported by 33 patients (52%) in the endoscopic group and 53 patients (82%) in the open group (number needed to treat 3.4,95% confidence interval 2.3 to 7.7) and the mean score difference for severity of pain in scar or palm and limitation of activity was 13.3 (5.3 to 21.3). No differences between the groups were found in the other outcomes. The median length of work absence after surgery was 28 days in both groups. Quality of life measures improved substantially. Conclusions In carpal tunnel syndrome, endoscopic surgery was associated with less postoperative pain than open surgery, but the small size of the benefit and similarity in other outcomes make its cost effectiveness uncertain.
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- Hofer, Manfred, et al.
(author)
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Extended Follow-up of Local Steroid Injection for Carpal Tunnel Syndrome : A Randomized Clinical Trial
- 2021
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In: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 4:10
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Journal article (peer-reviewed)abstract
- Importance: Local steroid injection is commonly used in treating patients with idiopathic carpal tunnel syndrome, but evidence regarding long-term efficacy is lacking. Objective: To assess the long-term treatment effects of local steroid injection for carpal tunnel syndrome. Design, Setting, and Participants: This exploratory 5-year extended follow-up of a double-blind, placebo-controlled randomized clinical trial was conducted from November 2008 to March 2012 at a university hospital orthopedic department. Participants included patients aged 22 to 69 years with primary idiopathic carpal tunnel syndrome and no prior treatment with local steroid injections. Data were analyzed from May 2018 to August 2018. Interventions: Patients were randomized to injection of 80 mg methylprednisolone, 40 mg methylprednisolone, or saline. Main Outcomes and Measures: The coprimary outcomes were the symptom severity score and rate of subsequent carpal tunnel release surgery on the study hand at 5 years. Secondary outcomes were time from injection to surgical treatment, SF-36 bodily pain score, and score on the 11-item disabilities of the arm, shoulder, and hand scale. Results: A total of 111 participants (mean [SD] age at follow-up, 52.9 [11.6] years; 81 [73.0%] women and 30 [27.0%] men) were randomized, with 37 in the 80 mg methylprednisolone group, 37 in the 40 mg methylprednisolone group, and 37 in the saline placebo group. Complete 5-year follow-up data were obtained from all 111 participants with no dropouts (100% follow-up). At baseline, mean (SD) symptom severity scores were 2.93 (0.85) in the 80 mg methylprednisolone group, 3.13 (0.70) in the 40 mg methylprednisolone group, and 3.18 (0.75) in the placebo group, and at the 5-year follow up, mean (SD) symptom severity scores were 1.51 (0.66) in the 80 mg methylprednisolone group, 1.59 (0.63) in the 40 mg methylprednisolone group, and 1.67 (0.74) in the placebo group. Compared with placebo, there was no significant difference in mean change in symptom severity score from baseline to 5 years for the 80 mg methylprednisolone group (0.14 [95%CI, -0.17 to 0.45]) or the 40 mg methylprednisolone group (0.12 [95%CI, -0.19 to 0.43]). After injection, subsequent surgical treatment on the study hand was performed in 31 participants (83.8%) in the 80 mg methylprednisolone group, 34 participants (91.9%) in the 40 mg methylprednisolone group, and 36 participants (97.3%) in the placebo group; the number of participants who underwent surgical treatment between the 1-year and 5-year follow-ups was 4 participants (10.8%) in the 80 mg methylprednisolone group, 4 participants (10.8%) in the 40 mg methylprednisolone group, and 2 participants (5.4%) in the placebo group. All surgical procedures were conducted while participants and investigators were blinded to type of injection received. The mean (SD) time from injection to surgery was 180 (121) days in the 80 mg methylprednisolone group, 185 (125) days in the 40 mg methylprednisolone group, and 121 (88) days in the placebo group. Kaplan-Meier survival curves showed statistically significant difference in time to surgical treatment (log-rank test: 80 mg methylprednisolone vs placebo, P =.002; 40 mg methylprednisolone vs placebo, P =.02; methylprednisolone 80 mg vs 40 mg, P =.37). Conclusions and Relevance: These findings suggest that in idiopathic carpal tunnel syndrome, local methylprednisolone injection resulted in statistically significant reduction in surgery rates and delay in need for surgery. Trial Registration: ClinicalTrials.gov Identifiers: NCT00806871 and NCT02652390.
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