Department of Physical Medicine and Rehabilitation, Izzet Baysal Physical Medicine and Rehabilitation Training and Research Hospital, Bolu, Turkey.
Department of Medical Ecology and Hydroclimatology, Usak University Faculty of Medicine, Uşak, Turkey.
Complement Ther Med. 2020 Nov;54:102550. doi: 10.1016/j.ctim.2020.102550. Epub 2020 Sep 4.
This study aimed to compare whether there are positive effects of balneotherapy(BT) on pain, quality of life and disability of individuals receiving physical therapy(PT) for chronic low back pain and to examine the effect of body mass index(BMI) on treatment.
This prospective, controlled, single blind study was conducted. Patients were randomized into two groups through a simple randomization in a 1:1 ratio. The clinician and biostatistics expert were blinded. PT group was applied PT, BT + PT group was applied PT + BT. All patients were included in the study for 3 weeks (total of 15 sessions, 5 days per week). All patients applied hot pack, transcutaneous electrical nerve stimulation and ultrasound. Patients in the BT + PT group applied BT in thermo mineralized water pool (20 min at 38-40 °C). Assessments were made using Pain-Visual Analog Scale(VAS), EQ-5D-3 L Scale(EQ5), EQ-VAS, Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F), Roland-Morris Disability Questionnaire(RMDQ) and Quebec Back Pain Disability Scale(QBPDS) at the beginning (W0) and end (W3) of treatment. While performing statistical analysis, patients were divided into 3 categories of BMI1(18.5-24.9 kg/m), BMI2 (25.0-29.9 kg/m) and BMI3(≥30.0 kg/m).
270 patients were randomized. 129 patients in PT group and 133 patients in PT + BT group completed the study. In the BT + PT group, there were increases in the EQ5 and EQ-VAS variables and decreases in all other variables compared to the PT group which were found to be statistically significant (for QBPDS p < 0.05, the others p < 0.01). The differences in all variables W0 and W3 were at least half reductions and increases which were found to be statistically significant (p < 0.01). In terms of BMI, there were significant differences for all groups, especially BMI3 had higher means for all variables apart from EQ5 and EQ-VAS than the other two categories. BMI1 was the BMI category with highest means for EQ5 and EQ-VAS. The Group × Time interaction was found to be statistically significant for Pain-VAS, EQ5, EQ-VAS, FACIT-F, QBPDS and RMDQ(p < 0.01). For Pain-VAS, the effect of the Group × Time × BMI interaction was found to be statistically significant(p < 0.05).
BT plus PT was more effective than PT. BT may have positive contributions to reducing pain, functionality of patients, quality of life, fatigue and disability status.
本研究旨在比较温泉浴疗法（BT）对接受物理治疗（PT）的慢性下腰痛患者的疼痛、生活质量和残疾的积极影响，并检验体重指数（BMI）对治疗的影响。
这是一项前瞻性、对照、单盲研究。患者通过简单随机化以 1:1 的比例随机分为两组。临床医生和生物统计学专家均设盲。PT 组接受 PT 治疗，BT+PT 组接受 PT+BT 治疗。所有患者均接受 3 周（共 15 次，每周 5 天）的治疗。所有患者均应用热包、经皮神经电刺激和超声治疗。BT+PT 组患者在 38-40°C 的热矿化水中池应用 BT（20 分钟）。在治疗开始时（W0）和结束时（W3），使用疼痛视觉模拟量表（VAS）、EQ-5D-3L 量表（EQ5）、EQ-VAS、慢性疾病治疗疲劳功能评估量表（FACIT-F）、Roland-Morris 残疾问卷（RMDQ）和魁北克腰痛残疾量表（QBPDS）对患者进行评估。在进行统计分析时，患者被分为 3 个 BMI 类别：BMI1（18.5-24.9kg/m）、BMI2（25.0-29.9kg/m）和 BMI3（≥30.0kg/m）。
共纳入 270 名患者，其中 PT 组 129 例，PT+BT 组 133 例完成了研究。与 PT 组相比，BT+PT 组的 EQ5 和 EQ-VAS 变量增加，所有其他变量减少，差异有统计学意义（QBPDS 为 p<0.05，其余为 p<0.01）。W0 和 W3 时所有变量的差异至少减少了一半，差异有统计学意义（p<0.01）。就 BMI 而言，所有组之间均存在显著差异，尤其是 BMI3 在除 EQ5 和 EQ-VAS 以外的所有变量上的平均值均高于其他两个类别。BMI1 是 EQ5 和 EQ-VAS 平均值最高的 BMI 类别。Pain-VAS、EQ5、EQ-VAS、FACIT-F、QBPDS 和 RMDQ 等变量的组×时间交互作用具有统计学意义（p<0.01）。对于 Pain-VAS，发现组×时间×BMI 交互作用具有统计学意义（p<0.05）。
BT+PT 比 PT 更有效。BT 可能对减轻疼痛、改善患者的功能、生活质量、疲劳和残疾状况有积极贡献。
