Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- pressure pain threshold (PPT)
研究概览
简要总结
Background & Purpose: Cervical radiculopathy is a neurological disorder, which commonly results because of nerve compression. There are different types of physical therapy interventions that are used for cervical radiculopathy. The evidence of effectiveness of manual therapy in cervical radiculopathy is still limited. Short-term hypoalgesic effects after manual therapy was found in different musculoskeletal conditions. However, the effectiveness of manual therapy in patients with cervical radiculopathy hasn't been investigated yet. Therefore, the aim of study is to examine the short-term effect of manual therapy (mobilization) on the sensory features in patients with chronic cervical radiculopathy.
详细描述
Participants:
The sample size was calculated using G*power 3.1(F test, analysis of variance [ANOVA]: repeated measure, within between interaction, and a priori: compute required sample size). A result of 10 participants (treatment group=5 and sham group=5) was used to calculate the effect size (ES) of 0.44 for the pressure pain threshold on the cervical spine after the intervention(immediate effect) between group. The power estimated for ANOVA for the two group with a significance of 0.05 revealed that a total sample size of 28 participants was necessary to obtain a power of 0.80. . a minimum of 14 needed to be recruited in this study Participants with unilateral neck pain and radiating symptoms to upper extremity of more than three months were recruited from King Abdul-Aziz Hospital and East Jeddah general hospital in Jeddah, Saudia Arabia All patients signed a consent form before they participate in the study after explaining all procedures to them. The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: PGS-20160-30-142) and was approved by ministry of health at Saudia Arabia (IRB number: H-02J-002). All electronic data pertinent to the patients were being saved in a secured laptop, whereas the paper document will be kept in a locked cabinet.
Data analysis:
All statistical analysis was performed using IBM SPSS version 20 (Armonk, NY: IBM Corp). Significance levels will be set at p ≤ 0.05. Mean and standard deviation will be calculated as descriptive statistics. One-way repeated measures analysis of variance (ANOVA) and post hoc comparison, if needed will calculate the differences in the outcome measures: Quantitive sensory testing (QST), pain intensity, and active CROM
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral neck pain and radiating to upper extremity > 3 months.
- •age :between 35 to 65 years old.
- •Presence 3 out of 4 positive findings:
- •spurling test.
- •distraction test,
- •upper limb neurodynamic test for median nerve
- •ipsilateral cervical rotation test less than 60 degrees.
排除标准
- •osteoporosis.
- •metabolic disease (DM,resting blood pressure are greater than 140/90).
- •rheumatoid arthritis.
- •history of whiplash injury.
- •myelopathy.
- •history of cervical or thoracic surgery
- •generalized neurological disorders .
- •leg surgery or disease (fracture) -
结局指标
主要结局
pressure pain threshold (PPT)
时间窗: Change from baseline in PPT at 3 weeks post intervention
An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).
次要结局
- The Neck Disability Index (NDI)(Change from baseline in NDI at 3 weeks post intervention)
- Active Cervical Range of Motion(Change from baseline in CROM at 3 weeks post intervention)
- Warmth/cold detection threshold and heat/cold pain threshold(Change from baseline in thermal detection & pain threshold at 3 weeks post intervention)
- Numerical Pain Rating Scale (NPRS)(Change from baseline in NPRS at 3 weeks post intervention)