Van Der Heijden G J, Leffers P, Wolters P J, Verheijden J J, van Mameren H, Houben J P, Bouter L M, Knipschild P G
Institute for Rehabilitation Research, Hoensbroek, The Netherlands.
Ann Rheum Dis. 1999 Sep;58(9):530-40. doi: 10.1136/ard.58.9.530.
To assess the efficacy of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (SD).
Randomised placebo controlled trial with a two by two factorial design plus an additional control group in 17 primary care physiotherapy practices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without underlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were randomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment.
recovery, functional status, chief complaint, pain, clinical status, and range of motion.
After written informed consent 180 patients were randomised: both the active treatments were given to 73 patients, both the dummy treatments to 72 patients, and 35 patients received no adjuvants. Prognosis of groups appeared similar at baseline. Blinding was successfully maintained. At six weeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable thereafter. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero.
Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.
评估双极干扰电疗法（ET）和脉冲超声（US）作为运动疗法辅助手段治疗肩部软组织疾病（SD）的疗效。
在荷兰南部17家初级保健物理治疗机构进行的一项采用二乘二析因设计加一个额外对照组的随机安慰剂对照试验。因软组织损伤而非潜在特定或全身性疾病导致肩部疼痛和/或肩部活动受限的患者，若在两周内接受六次运动疗法后仍未康复，则纳入研究。他们被随机分为接受：（1）活性ET加活性US；（2）活性ET加假US；（3）假ET加活性US；（4）假ET加假US；或（5）不使用辅助手段。此外，他们在六周内最多接受12次运动疗法。基线、6周以及3、6、9和12个月后的测量对治疗是盲法的。
恢复情况、功能状态、主要诉求、疼痛、临床状态和活动范围。
在获得书面知情同意后，180名患者被随机分组：73名患者接受两种活性治疗，72名患者接受两种假治疗，35名患者不使用辅助手段。各小组在基线时的预后情况相似。成功维持了盲法。六周时，7名（20%）不使用辅助手段的患者报告有非常大的改善（包括完全康复），接受活性和假ET的患者分别有17名（23%）和16名（22%），接受活性和假US的患者分别有19名（26%）和14名（19%）。这些比例在三个月时增至约40%，但此后基本保持稳定。随访至12个月，所有观察指标组间差异的95%置信区间均包含零。
对于肩部软组织疾病，ET和US作为运动疗法的辅助手段均未被证明有效。
