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临床试验/NCT03329482
NCT03329482已完成不适用

Effect of Pulse Ultrasound and Kneading Massage Using Lofnac -Gel in the Management of NSCLBP

Obafemi Awolowo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The verbal rating scale

研究概览

简要总结

Back pain is one of humanity most frequent complains. About nine of ten adults experience back pain at some points in their life and five out of ten working adults have back pain every year. When continued for long period it may constitute a disability which tries the patient of the most stoical individual as well as the doctor called to bring relief to the suffering victim.

Kneading massage with topical analgesic is a common practice by physiotherapist especially in Nigeria in the management of low back pain, work has been done to know the efficacy of lofnac gel (topical analgesic) via phonophoresis in the management of low back pain(ojoawo,2015), but the comparison of the efficacy of kneading massage and phonophoresis in the management of low back pain has not been well documented. The purpose of this study therefore, is to compare the efficacy of kneading massage and phonophoresis using lofnac gel in the treatment of non-specific chronic low back pain.

详细描述

The subjects for the study were patients with chronic non-specific low back pain (CNSLBP) receiving treatment at Physiotherapy Department, Osun State Specialist Hospital, Oshogbo, Nigeria. The inclusion criteria for the patients were patients with non-specific low back pain with symptom of pain lasting more than three months. Patients with nerve roots symptoms, underlying systemic or visceral disease, and specific conditions such as neoplasms, fracture, ankylosing spondylitis, previous low back surgery, and pregnancy were excluded from the study. The design of the study was quasi-experimental design.

Among other screening procedures, spinal movements that provoked pain were noted because spinal pain of mechanical origin may be reproduced by movement which induces tension and neural sliding 15). Straight leg raising and Ely's test were carried out according to Nwuga 16) and were found to elicit pain at the lower back. X- ray report of each patient was also reviewed and none of the reports indicated osteoporosis, carcinoma, or pot disease.

In order to determine the number of subjects to be involved, a sample size equation to compare two means according to Eng,17) was used:

N= 4δ2(Zcrit + Zpower)2/D2 Where N is the sample size (the sum of sizes of both comparison group). Where δ is the standard deviation of each group (assumed to have a value of six and to be equal for both groups). Zcrit is the standard normal deviation corresponding to the selective significant criterion [i.e. 0.05 (95% =1.960)].

4 Zpower is the standard deviation corresponding to the selective statistical power (i.e 0.80=0.842).

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)

盲法说明

One of the Physiotherapist who carried out the assessment especially when the intervention started did not aware of the study

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mechanical low back pain who have had pain for more than three months were eligible for the study.

排除标准

  • Patients with nerve roots symptoms, underlying systemic or viscera disease and specific condition such as neoplasm, fracture, ankylosing spondylolytis, previous low back surgery and pregnancy were excluded

结局指标

主要结局

The verbal rating scale

时间窗: 6 Weeks

The verbal rating scale is a 10-point rating scale that measures present pain intensity of patients. The scale started from 0 and ends with 10. 0 indicate no pain, 1 indicate minimal pain while 5 indicates moderate pain and 10 indicates the most difficult pain called excruciating pain

次要结局

  • Roland Morris Disability Questionnaire(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adesola Ojo Ojoawo

Principal Investigator

Obafemi Awolowo University

研究点 (2)

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