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A randomized controlled trial to compare the effectiveness of smart dynamic fabric actuator with exercises in chronic musculoskeletal leg pain associated with prolonged standing in a hospital setting
Kashyap V, Venkataraman S, Kumar B, Handa G, Pandey RM
Indian Journal of Occupational and Environmental Medicine 2024 Oct-Dec;28(4):319-325
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: There are adverse effects on the health outcomes of workers whose occupation involves prolonged standing, such as lower back pain, leg pain, cardiovascular diseases, fatigue, discomfort, and pregnancy-related health outcomes. The effectiveness of massage therapy as an intervention for managing leg pain associated with prolonged standing needs to be addressed. AIMS: This study aimed to evaluate the smart dynamic fabric actuator's effectiveness in treating chronic musculoskeletal leg pain in persons with occupations involving prolonged standing. SETTING: Tertiary care hospital. DESIGN: Randomized controlled trial. METHODS: Thirty participants with chronic leg pain satisfying the inclusion and exclusion criteria participated in the study. The intervention group used the device for 15 minutes for each leg once a day and stretching exercises twice a day for six weeks. The control group performed stretching exercises twice a day for six weeks. The outcome was assessed at baseline, three weeks, and six weeks with a Numeric Rating Scale for pain and fatigue, short form-McGill Pain Questionnaire for pain, and SF-36 for quality of life. STATISTICAL ANALYSIS: The groups were compared using the two-sample t-test with equal variances, the two-sample Wilcoxon rank-sum test, and the Chi2 exact test as appropriate. RESULTS: Thirty medical (nursing officers and doctors) and nonmedical professionals (security guards and sales assistants) with a mean age of 32.9 +/- 5.6 years (intervention group) and 36.2 +/- 5.1 years (control group) participated in the study. At six weeks, a significant improvement in pain (4.80 +/- 1.14 to 1.66 +/- 1.04 versus 4.66 +/- 0.89 to 2.6 +/- 0.91, p = 0.014), quality of life (58.77 +/- 9.06 to 71.76 +/- 8.43 versus 51.39 +/- 8.26 to 63.87 +/- 7.61, p = 0.012), and reduced fatigue (5 to 2 versus 5 to 3, p = 0.003) was observed in the intervention group when compared with the control group. No adverse events were observed. CONCLUSION: A smart dynamic fabric actuator can be used as an adjunct to exercises for reducing leg pain and fatigue associated with prolonged standing.

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