Wheeler Patrick C
Department of Sport & Exercise Medicine, University Hospitals of Leicester NHS Trust, Leicester, UK.
School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.
BMJ Open Sport Exerc Med. 2017 Jun 13;3(1):e000234. doi: 10.1136/bmjsem-2017-000234. eCollection 2017.
To identify any improvements in pain or function in patients with chronic plantar fasciitis following the use of a tension night splint (TNS).
Single-blinded randomised controlled trial, with participants split evenly between intervention group (TNS + home exercise programme/HEP) and control group (HEP only). Follow-up at 3 months, with interim data at 6 weeks.
40 patients recruited. Mean age 52.1 years, 33% male, mean body mass index 30.8 kg/m, mean duration of symptoms of 25 months. Improvement in self-reported 'average pain' in the intervention group from 6.8/10 at baseline to 5.6/10 at 6 weeks, and 5.3/10 at 3 months (both clinically and statistically significant at both time points), compared with control group of 7.1/10 at baseline to 6.2/10 at 6 weeks and 5.6/10 at 3 months (significant only at 3 months). Improvements in self-reported 'worst pain', 'pain walking' and 'pain first thing in the morning' in both groups at all time periods. Improvements were seen in revised Foot Function Index at all time points in both groups, but limited changes seen in flexibility and no significant changes in anxiety or depression Hospital Anxiety and Depression Scale domains or sleep quality in either group. However, no differences were seen between the outcomes seen in the two groups for the majority of the measures studied.
Improvements in pain and some functional measures seen in both groups, with few, if any, differences seen in outcomes between the intervention group compared with the control group. However, ongoing pain symptoms were reported in both groups, suggesting that 'help' rather than 'cure' was obtained for the majority. There is a possibility of earlier benefit seen in the intervention group compared with the control group, but data are unclear and further work may be needed.
ClinicalTrials.gov: NCT02546115; results.
确定使用张力夜间夹板(TNS)后慢性足底筋膜炎患者在疼痛或功能方面是否有任何改善。
单盲随机对照试验,参与者平均分为干预组(TNS + 家庭锻炼计划/HEP)和对照组(仅HEP)。在3个月时进行随访,在6周时有中期数据。
招募了40名患者。平均年龄52.1岁,33%为男性,平均体重指数30.8 kg/m,平均症状持续时间25个月。干预组自我报告的“平均疼痛”从基线时的6.8/10改善到6周时的5.6/10,3个月时为5.3/10(在两个时间点均具有临床和统计学意义),而对照组从基线时的7.1/10改善到6周时的6.2/10,3个月时为5.6/10(仅在3个月时有显著改善)。两组在所有时间段自我报告的“最严重疼痛”、“行走疼痛”和“早晨醒来时的疼痛”均有改善。两组在所有时间点的修订足部功能指数均有改善,但灵活性变化有限,两组在焦虑或抑郁(医院焦虑抑郁量表领域)或睡眠质量方面均无显著变化。然而,在大多数研究指标中,两组的结果没有差异。
两组在疼痛和一些功能指标上均有改善,干预组与对照组的结果差异很小(如果有差异的话)。然而,两组均报告有持续的疼痛症状,这表明大多数患者得到的是“帮助”而非“治愈”。与对照组相比,干预组可能有更早的获益,但数据不明确,可能需要进一步研究。
ClinicalTrials.gov:NCT02546115;结果