Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Low back of pain intensity measured with Numeric Pain Rating Scale
研究概览
简要总结
Non-specific low back pain is a common condition. Insoles are one of the many treatment form for chronic nonspecific LBP. The investigators hypothesized the contact total insole group will present pain reduction and functional improvement.
The aim of this study is to assess the effectiveness of contact total insole for people with nonspecific chronic low back pain and the impact of this insole on function, quality of life, load distribution in the plantar region, gait variables and satisfaction with insole use.
详细描述
A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Eighty-four patients with nonspecific chronic low back pain will be randomly into a study group and control group. One week following the baseline evaluation, the study group will receive a contact total insole made of ethyl vinyl acetate and the control group will receive a flat insole made of the same material, color and density. The groups will be evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters will be employed: low back pain numerical pain scale; functional capacity (Oswestry and roland morris questionnaire, six minute walk test and timed to up and go test); quality of life (Short Form-36) and foot pressure analysis using the AMCube FootWalk Pro program.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain for more than 3 months, with numeric pain scale between 3 - 8 cm;
- •Over 18 years;
- •No distinction of sex;
- •Understand Portuguese well enough to be able to fill in the questionnaires;
- •Agree to participate of the study and sign the informed consent form.
排除标准
- •Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
- •Litigation;
- •Fibromyalgia;
- •Other symptomatic musculoskeletal diseases in lower limbs;
- •Symptomatic diseases of the central and peripheral nervous system;
- •Diabetes Mellitus;
- •Rigid deformities on foot;
- •Use of insoles in the last three months;
- •Medical or physiotherapeutic treatment for low back pain or any problem in lower limbs in the last three months;
- •People who had changed physical activity or undergone physical therapy in the previous 3 months;
- •Pregnancy;
- •Difference of lower limbs greater than 2 cm
- •Less than 6 months after lumbar spine, lower limb or abdomen surgery
- •Previous spinal surgery;
- •Previous spinal infiltration for pain relief in the last 3 months;
- •Serious scoliosis;
- •Allergy to the material of the insole.
- •Planned travel in the next 12 weeks;
- •Geographic inaccessibility.
研究组 & 干预措施
Total Contact Insole Group
Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months.
干预措施: Total Contact Insole (Device)
Flat Insole group
Flat insole made the same material ethyl vinyl acetate, every 6 months.
干预措施: Ethyl vinyl acetate flat insole (Device)
结局指标
主要结局
Low back of pain intensity measured with Numeric Pain Rating Scale
时间窗: Baseline, 45, 90 and 180 days
It will be measured by the Brazilian version of the Numeric Pain Rating Scale 10 cm. The Numeric Pain Rating Scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last week. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.
次要结局
- Quality of life measured with Short form-36 questionnaire(Baseline, 45, 90 and 180 days)
- Functional capacity measured with Oswestry Disability Index(Baseline, 45, 90 and 180 days)
- Amount Medication consumption(45, 90 and 180 days after baseline)
- Patient's global impression of recovery measured with a likert scale(45, 90 and 180 days after baseline)
- Foot pressure analysis using the AMCube FootWalk Pro program(baseline, 90 and 180 days after baseline)
- Functional capacity measured with Roland Morris Disability(Baseline, 45, 90 and 180 days)
- Functional capacity measured with the 6-minute walk test(Baseline, 45, 90 and 180 days)
- Functional capacity measured with the timed to up and go test(Baseline, 45, 90 and 180 days)
研究者
Anamaria Jones
Head of Rheumatology Rehabilitation Section - Rheumatology Division
Federal University of São Paulo