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Randomized study of the impact of a therapeutic education program on patients suffering from chronic low-back pain who are treated with transcutaneous electrical nerve stimulation |
Garaud T, Gervais C, Szekely B, Michel-Cherqui M, Dreyfus JF, Fischler M |
Medicine 2018 Dec;97(52):e13782 |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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: Transcutaneous electrical nerve stimulation (TENS) is often used for the treatment of low-back pain (LBP). However, its effectiveness is controversial. OBJECTIVE: To determine the efficacy of TENS in the treatment LBP when associated to a therapeutic education program (TEP). DESIGN: Open randomized monocentric study. SETTING: University hospital between 2010 and 2014. PATIENTS: A total of 97 patients suffering from LBP. INTERVENTIONS: Routine care (TENS group) or routine care plus a therapeutic education program (TENS-TEP group) based on consultation support by a pain resource nurse. MAIN OUTCOME MEASURES: EIFEL and Dallas Pain Questionnaire scores. RESULTS: Twenty-two patients (44%) were still assessable at the end-of-study visit, whereas 33 (70%) were assessable at the same time point in the TENS-TEP group (p = 0.013). The EIFEL score and the Dallas score had a similar evolution over time between groups (p = 0.18 and p = 0.50 respectively). Similarly, there were no significant differences between the groups with respect to resting pain scores (p = 0.94 for back pain and p = 0.16 for leg pain) and movement pain scores (p = 0.52 for back pain and p = 0.56 for leg pain). At Month 6, there was no significant difference between the groups (p = 0.85) with regard to analgesics and social impact. Two patients presented a serious adverse event during the study (one in each group) but non-attributable to the treatment studied. CONCLUSION: This study does not support the use of TENS in the treatment of patients with chronic LBP even though patients benefited from a therapeutic education program by a pain resource nurse. However, the higher number of premature withdrawals in the TENS group may be due to early withdrawal of patients who did not experience improvement of their symptoms.
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