Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.
College of Public Health, University of Iowa, Iowa City, IA, United States.
Pain. 2021 May 1;162(5):1545-1555. doi: 10.1097/j.pain.0000000000002144.
We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.
我们之前的研究表明，电神经刺激（TENS）治疗 1 个月可减轻纤维肌痛（FM）女性的运动诱发疼痛和疲劳。使用这项研究（TENS 纤维肌痛活动研究[FAST]）的数据，我们进行了应答者分析，以确定 TENS 治疗疼痛和疲劳改善的预测因素，使用接受者操作特征验证这些模型，并确定需要治疗的人数和需要伤害的人数。参与者被随机分配到经皮电神经刺激（2-125 Hz；可耐受的最高强度）、安慰剂电神经刺激或不接受电神经刺激治疗 1 个月。在随机阶段结束时，安慰剂电神经刺激和不接受电神经刺激组接受 1 个月的经皮电神经刺激治疗。预测模型是使用经皮电神经刺激治疗组的随机阶段数据（n=103）开发的，并在经皮电神经刺激治疗 1 个月后使用安慰剂电神经刺激和不接受电神经刺激组的数据进行验证（n=155）。参与者的特征、对疼痛和疲劳的初始 TENS 反应、睡眠、心理因素和功能，都使用逻辑回归模型进行了筛选，以评估其与疼痛或疲劳变化的关联。疼痛临床改善的预测因素是疼痛和广泛性疼痛指数的初始反应（曲线下面积为 0.80；95%置信区间：0.73-0.87）。疲劳临床改善的预测因素是婚姻状况、睡眠障碍和 TENS 的初始反应（曲线下面积为 0.67；95%置信区间：0.58-0.75）。疼痛和疲劳的治疗人数在 3.3 到 5.3 之间。轻微的与 TENS 相关的不良反应需要治疗的人数从 20 到 100 不等。对初始 30 分钟 TENS 治疗的反应预测了谁会对 FM 女性的长期 TENS 治疗有反应，这是一种临床有用的方法。需要治疗的人数和需要伤害的人数表明，TENS 对 FM 的疼痛和疲劳管理有效且安全。
