Efficiency of Sensory Discrimination Training in 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
- 27
- 试验地点
- 2
- 主要终点
- Pain pressure threshold
研究概览
简要总结
In this study, the effect of sensory discrimination training on cortical reorganization, pain and functionality in chronic nonspecific low back pain in which central sensitization is dominant will be investigated.
详细描述
Patients who agree to participate in the study will be assigned to Group I (core stabilization) or Group II (core stabilization+sensorial discrimination training) after being screened and randomized according to the inclusion criteria on day one. On the first day, all evaluations will be carried out by taking informed consent form from the participants. With the participants in Group I, progressive core stabilization exercises will be practiced for 20-30 minutes a day, 2 days a week for 10 weeks. In Group II, sensorial discrimination training will be studied for 20 minutes before core stabilization exercises. Core stabilization exercise will be performed in accompany with a physiotherapist who has a I. Level mat exercises certificate. At the end of each week, participants will be questioned about the use of an adjunctive intervention to treatment, including changes in medication use, or the presence of an unexpected reaction to treatment, and their responses recorded. All assessments will be repeated before treatment, at the end of the 6th week, and at the end of the 10th week. The primary outcome is cortical reorganisation which will be assessed with tactile localization, two point discrimination, pressure pain threshold. Also, proprioception of the lumbal region, lumbopelvic control, pain intensity, functionality, central sensitization, pain catastrophizing, kinesiophobia, and quality of life of the participants will be assessed. Power and Sample Size Program was used to calculate the sample size. Minimal clinically important difference (MCID) and standard deviation (SD) values were used during the calculation. For the Numerical Rating Scale, the MCID value was 4.15 and the Standard Deviation value was 3. It was calculated that a total of 15 participants, 15 participants in both groups, should be included in the study. A total of 36 participants will be included in the study by calculating a 20% probability due to the possibility of the participants being excluded from treatment or dropped out.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be between 30 and 60 years old
- •To have pain lasting longer than 3 months
- •To have pain intensity greater than 4 out of 10
- •To have pain that is not compatible with anatomical structures and is widespread
- •To get score of 40 or more from the Central Sensitization Inventory
排除标准
- •Inability to perceive the sense of touch in the waist
- •Being pregnant
- •Using a pacemaker or being diagnosed with heart disease
- •Having an open wound in the waist
- •Using drugs that affect the central system (dopamine, etc.)
- •Having a history of surgery related to the spine
- •Presence of a neurological injury or disease
- •Having a Body Mass Index of 30 or more
- •To have a diagnosis of fibromyalgia
研究组 & 干预措施
Control group
干预措施: Core stabilization (Other)
Training Group
干预措施: Sensorial Discrimination Training (Other)
Training Group
干预措施: Core stabilization (Other)
结局指标
主要结局
Pain pressure threshold
时间窗: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
Pain pressure threshold (PPT) will be assessed as a clinical sign of cortical reorganisation. Within the scope of the study, PPT measurement will be made using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). The tests will be applied to the Gluteus medius (middle and posterior part), Gluteus minimus, Gluteus maximus, Piriformis, Quadratus lumborum and Iliopsoas muscles by using a 1 cm2-pointer and increasing the pressure intensity by 1 kg/cm2 every second. The participants will be asked to tell the evaluator the point where the pressure to be applied turns into mild pain, and the average of three tests performed at 30-second intervals will be recorded in kg/cm2.
Tactile localization
时间窗: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
Tactile localization will be assessed as a clinical sign of cortical reorganisation. The participant will be asked to hold a pencil perpendicular to the surface at the level of the 12th thoracic vertebra in the hand ipsilateral to the tested body side (right hand if the right side of the back has been tested). The researcher will lightly touch one of the predetermined localizations and the participant will be instructed as "Use your pen to touch the point I touched as accurately as possible. Don't slide, lift the pen.". For statistical analysis, the distance between the pre-marked points and the points defined by the participant will be recorded by measuring with the caliper. This procedure will measure three times for each of the six designated points. The reliability of this test has been demonstrated in previous studies.
Two-point discrimination
时间窗: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
Two-point discrimination (TPD) will be assessed as a clinical sign of cortical reorganisation. TPD is a reliable measure for detecting touch accuracy. A digital caliper (Powerfix) will be used for TPD measurements and the participant will not see the caliper during the measurement. With the participant lying prone, the researcher will measure horizontal TPD at the L4 level bilaterally. The distance between the tips of the caliper varies between 100 mm and 5 mm, the test will be started at the maximum aperture, The distance will be reduced by 10 mm for each correct detection and increased by 5 mm for each false detection. This process will be repeated three times in descending and ascending order, and the average of the smallest distance between the caliper tips at which the participant can distinguish two separate points will be recorded as the TPD value. This measurement protocol was taken from a previous study.
次要结局
- Lumbopelvic motor control(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Pain intensity(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Pain catastrophizing(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Central Sensitization(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Proprioception(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Functionality(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Kinesiophobia(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
- Short Form-12(Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment))
研究者
Aybike Senel
Research Assistant, PT, MSc, Research Assistant, Principal investigator
Istanbul University - Cerrahpasa