Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
研究概览
简要总结
Background:
Low back pain is the leading cause of disability, affecting the quality of life and work productivity.
It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment
- Study objectives:
To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy. 2. Study hypotheses:
The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.
- Pain reduction.
- Less disability - improvement in daily activities.
- Better feeling of health and well-being.
- Increased and better compliance to daily sport activities.
- BMI reduction.
- Reduction of cigarette smoking.
- Reduction of usage of anti-analgesics and anti-inflammatory medications.
- Reduction in number of visits to Physical Therapy clinics due to low back pain.
- Methods:
The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.
These individuals will be randomized to one of the following two groups:
- Conventional Physical Therapy.
- Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.
Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age 25-55 years old
- •Chronic / recurrent low back pain (over 3 months)
- •With or without radiation
排除标准
- •Rheumatoid disease
- •Fibromyalgia
- •Back surgery
- •Road / work accidents
- •Non Hebrew speaking
- •Pregnancy
结局指标
主要结局
Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
时间窗: 3 months, 1, 2 and 5 years
次要结局
- Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years(3 months, 1, 2 and 5 years)