Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lumbar pain change with the Pain Detect Questionnaire
研究概览
简要总结
A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. The interventions are conducted in 3 sessions provided during 3 weeks.The lumbar pain and disability are assessed before and after the intervention, and lumbar flexion and extension pain are assessed before and after each session in all the participants.
详细描述
This study is a randomized controlled trial evaluating clinical effects of a protocol of Physical Therapy Treatment (PTT), via manual therapy and active mobilization, adding or not a magnetic field therapy in people with non-specific low back pain lasting at least 6 weeks. Participants were randomized to receive either a PTT protocol including a magnetic stimulation treatment or the same PTT protocol with a sham magnetic intervention. The interventions are conducted in 3 sessions provided during 3 weeks.
Intervention:
A description of the 2 groups of treatment:
-
- Experimental group 1: a protocol of physical therapy treatment including:
- Manual therapy techniques for inhibition of piriformis, quadratus lumbar, and paravertebral muscles in prone position and bilaterally.
- 2 functional techniques applied to the sacrum in prone position.
- A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
- Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
- Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
- Active gluteus maximus contraction in supine position bilaterally.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
To participants: the intervention applied to both groups is the same Physical Therapy Treatment protocol and the use of the same magnetic field therapy device during the same time (for the sham group: the device is disconnected and the sound is simulated with a recording).
The investigator assessing the outcomes is blinded to the group assignments
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
- •The inclusion criteria were individuals aged between 18 and 65 years with a diagnosis of non-specific low back pain, with or without lower limb irradiation, lasting at least 6 weeks.
排除标准
- •Pregnancy, spinal tumor or infection, diabetes, spinal fracture or previous spine surgery.
- •Patients with a history of rehabilitation treatment for back pain within the preceding month
- •Unstable medical disorder not controlled by standard treatment and those with a cardiac pacemaker or using any other electrical devices or prosthesis.
研究组 & 干预措施
Group 1 (Physical Therapy+Magnetic Field Therapy)
Physical Therapy Protocol plus Magnetic Field Therapy
A protocol of physical therapy treatment including:
- Manual therapy techniques for inhibition of piriformis, quadratus lumbaris, and paravertebral muscles in prone position and bilaterally.
- 2 functional techniques applied to the sacrum in prone position.
- A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
- Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
- Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
- Active gluteus maximus contraction in supine position bilaterally.
To this protocol, a 15 minutes of Magnetic Field Therapy using the Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) applied to the lumbosacral region in prone position is added.
干预措施: Group 1 (Physical Therapy+Magnetic Field Therapy) (Other)
Group 2 (Physical Therapy)
Physical Therapy Protocol alone:
The same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected Zimmer EmfieldPro device (Zimmer MedizinSysteme, Germany) during 15 minutes.
干预措施: Group 2 (Physical Therapy) (Other)
结局指标
主要结局
Lumbar pain change with the Pain Detect Questionnaire
时间窗: Change from Baseline Lumbar pain at 4 weeks.
lumbar pain at this moment and in the last 4 weeks evaluated with the Pain Detect Questionnaire. The Questionnaire has a maximum score of 35 and a minimum score of 0. Lower scores mean a better outcome.
Disability Questionnaire 1 change
时间窗: Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire assessed with the Roland-Morris Questionnaire. The Questionnaire has a maximum score of 24 and a minimum score of 0. Lower scores mean a better outcome.
Disability Questionnaire 2 change
时间窗: Change from Baseline degree of diability at 4 weeks.
Disability Questionnaire 2 assessed with the Oswestry Disability Index. The Oswestry Disability Index is scored from 0 (absence of disability) to 100 (maximum disability). This questionnaire has 10 multiple-choice questions, each of which may be scored between 0 (no disability) and 5 (maximum disability). Lower scores mean a better outcome.
次要结局
- Lumbar flexion Numerical Rating Scale(4 weeks (immediately before and after each of the sessions))
- Lumbar extension Numerical Rating Scale(4 weeks (immediately before and after each of the sessions))
- Finger to Floor test(4 weeks (immediately before and after each of the sessions))