Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
研究概览
简要总结
This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.
详细描述
Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria.
The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group.
Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 60 years with chronic low back pain
- •Those who have complained of low back pain for at least 3 months
- •Individuals whose pain intensity is above 3.5 cm according to VAS
- •Pain and numbness that does not spread to the legs
排除标准
- •Situations that prevent the evaluation or communication with the individual
- •Illiterate individuals
- •Individuals who have undergone surgical operations on the spine and / or extremities
- •Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
- •Orthopedic and neurological problems that prevent evaluation and / or treatment
- •Complaints of pain and numbness spreading to the lower extremities
- •Individuals with a diagnosed psychiatric illness
- •Individuals who have received physiotherapy in the last 6 months
- •Individuals who use another treatment method during the study
- •Individuals with musculoskeletal pain in any other part of the body during work
研究组 & 干预措施
Conventional Physiotherapy
Classical electrotherapy method consisting of tens, hotpack and ultrasound. Procedure/Device: Conventional Physiotherapy Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm2 and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
干预措施: conventional physiotherapy (Other)
Conventional Physiotherapy + Kinesiotaping
Kinesiotaping application in addition to classical electrotherapy method consisting of tens, hotpack and ultrasound.It will be applied to reduce pain, increase proprioception and awareness. Kinesiotaping will be re-applicated every day. Space taping will be applied to the waist area. Space taping creates a vacuum effect on the skin, loosening the adhesions in the tissue layers. With this lifting effect, it creates a space under the skin, causing an increase in circulation and a decrease in pain. Four pieces of I-tape will be used for taping. The middle point of the first tape will be attached with maximum tension. The ends of the tape will be tensionless. The second tape will also be applied at a 90 degree angle. The third and fourth tapes will be taped at an angle of 45 degrees.
干预措施: conventional physiotherapy plus kinesiotaping (Other)
结局指标
主要结局
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Modified Schober Test
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Repeated Sit-to-Stand Test
Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Timed Up and Go Test
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.
Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.
Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.
Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks
时间窗: Baseline, 3 weeks, 6 weeks
Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
时间窗: Baseline, 3 weeks, 6 weeks
Roland Morris Disability Questionnaire.
次要结局
未报告次要终点
研究者
Özgür Nadiye Karaman
Physiotherapist, MSc
Pamukkale University