Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pain using VAS
研究概览
简要总结
Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.
Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.
Hypothesis - abdominal belt will improve pain in chronic low back pain patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from both genders,
- •between 18 and 65 years of age,
- •who sought medical care for a complaint of lumbar pain,
- •diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
- •who agreed to participate in the study and signed terms of informed consent.
排除标准
- •diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
- •fibromyalgia,
- •previous spinal surgery,
- •litigation (patients on leave from work or in work leave processes due to low back pain);
- •having changed physical activity in previous three months;
- •body mass index (BMI) higher than 30;
- •acupuncture treatment or physiotherapy in the previous three months
研究组 & 干预措施
Control group
Patients in the control group did not use an abdominal belt.
Experimental group
Patients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose.
干预措施: Abdominal belt (Device)
结局指标
主要结局
Change in pain using VAS
时间窗: Baseline, after 1,3, and 6 months
次要结局
- Change in functional capacity (Roland-Morris questionnaire)(Baseline, after 1,3 and 6 months)
- Change in hours of abdominal belt use(Baseline, after 1,3 and 6 months)
- Change in patient satisfaction with treatment using VAS(Baseline, after 1,3 and 6 months)
研究者
Jamil Natour
Head of Rheumatology Division
Federal University of São Paulo