Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Visual Scale Analogue (VAS)
研究概览
简要总结
The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.
详细描述
The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.
The project is a longitudinal, single-blind and randomized study with two treatment groups:
GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.
GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.
Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 70 years.
- •Diagnosis of back pain from a trauma.
- •Untreated pain (except acetaminophen).
- •Informed consent.
排除标准
- •Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
- •Cognitive impairment of any etiology.
- •Exercise intolerance for any reason.
- •Patients who have completed physical therapy in the last 3 months.
- •Patients who have received infiltration injections in the last 6 weeks.
研究组 & 干预措施
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
干预措施: Core Stability Exercises (CSE) (Procedure)
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
干预措施: TENS (Device)
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
干预措施: Infra-red (Device)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
干预措施: Traditional Back School (Procedure)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
干预措施: TENS (Device)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
干预措施: Infra-red (Device)
结局指标
主要结局
Changes in Visual Scale Analogue (VAS)
时间窗: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
The VAS scale represents the pain intensity on a line of 10 cm, and one end there are the words "no pain" and the other end "the worst imaginable pain" written the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain.
次要结局
- Changes in the Roland- Morris Disability Questionnaire(Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.)
研究者
M. Rosa Nogués
Pharm. D.
University Rovira i Virgili