Chronic Nonspecific Low back Pain (NLBP) is a common symptom in today's society. It causes serious health and economic burdens. Low back pain can be attributed to excessive physical exertion or trauma, resulting in damage or degradation of the vertebrae, intervertebral discs, or spinal muscles and nonspecific low back pain typically can account for 90% of the patients with 35 to 55 years old. Some guidelines endorse the cautious use of medication and surgery and take nonpharmacological and noninvasive treatments as a first-line treatment, including routine health education, exercise, psychotherapy, and physical therapies, owing to the risk of trauma and the cost. With a long history, Tuina is a one of the common nonsurgical methods to treat LBP in China.. The effect of Tuina is attributed to relaxing muscles and tendons, improving circulation, regulating spinal balance, decreasing edema and aseptic inflammation. Many clinical reports have confirmed its effectiveness, but more clinical trials are required to provide evidence of Tuina for low back pain. Therefore, this study was designed to compare the effectiveness of Tuina with Flurbiprofen Cataplasms for patients with low back pain on the basis treatment of health education and self-management exercise at home.
This study is a single-center, assessor- and analyst-blinded randomized controlled trial conducted in Beijing, China, at Dongzhimen hospital affiliated to Beijing university of Chinese medicine. In total, 90 patients will be recruited and randomly assigned to a Tuina group and a Flurbiprofen Cataplasms group in a 1:1 ratio. The Chinese Tuina group will be given twice per week for 14 days, and medicine group will be given Flurbiprofen Cataplasms twice daily for 14 days. We will ask some researchers who are blinded to assignment to accomplish the outcome assignment and statistical analyses independently. The outcome will be measured by three self-report questionnaires, which can reflect the lumbar dysfunction, pain, quality of life, and adverse events. Four time points will be used to assess outcomes, including baseline, 7 days, 14 days and 28 days after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Firstly, the patient is in the prone position, and the doctor use the method of rolling or kneading the Bladder meridians on both sides of the spine. The waist will be focused on to manipulate preferentially and then using the same technique on the patient's back, buttocks and lower limbs. Secondly, the physician will perform the manipulation on the patient's waist and the posterolateral side of the lower limbs by pressing, kneading, plucking. The doctors press the acupoints, including Mingmen(DU04),Shenshu(BL23),Yaoyangguan(DU03),Huantiao(GB30), Weizhong(BL40),Chengshan(BL57),and Ashi points, with the elbow or the thumb to achieve Deqi sensation. Thirdly, the The doctor uses the method of pressing acupoints, including Tianshu(ST25),Qichong(ST30),Chongmen(SP12),Daimai(GB26),Jingmen(GB25) on both sides. Fourthly, the patient is required to face the doctor in a lateral position for pulling manipulation on the both sides of lumbar vertebrae.
One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
Beiing university of Chinese medicine Dongzhimen Hospital
Beijing, Beijing Municipality, China
RECRUITINGChanges in NRS scores for pain intensity
The changes in NRS scores at 14 days after randomization.
Time frame: Change from baseline at 14 days
Changes in NRS scores for pain intensity
The NRS scores are measured at baseline, 7 days and 28days after randomization
Time frame: Change from baseline at 7 days and 28 days after randomization
Changes in the ODI scores for lumbar function
The ODI (Oswestry Low Back Pain Disability Index) scores are measured at baseline, 7 days, 14 days and 28 days after randomization
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Clinical effective rate
The clinical response rate is measured at baseline, 7 days, 14 days and 28 days after randomization
Time frame: Change from baseline at 7days,14days and 28 days after randomization
Changes in 7-level Likert Scale for patient assessment global improvement
The PAG with 7-level Likert Scale is measured at baseline, 7 days, 14 days and 28 days after randomization
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
The PAG with PROMIS® Scale v1.2 Scale is measured at baseline, 14 days after randomization
Time frame: Change from baseline at 14 days after randomization
Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
The Quebec Low Back Pain Disability Scale scores are measured at baseline and 14 days after randomization
Time frame: Change from baseline at 14 days after randomization
Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
The PROMIS® Item Bank v2.0-Physical Function-Short Form 8c 7-Day Scale scores are measured at baseline and 14 days after randomization
Time frame: Change from baseline at 14 days after randomization
Changes in Quality adjusted life years (QALY)
The quality adjusted life years (QALY) of the subjects were measured by TCM health-related life quality scale (CM-QOL), five-dimensional health scale (EQ-5D) and SF-6D at baseline, 7 days, 14 days and 28 days after randomization
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Incidence of adverse events
The incidence of adverse events during treatment will be calculated
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Cost-Effectiveness Analysis (CEA) ratio
The cost-effectiveness ratio (C/E) is measured at baseline,7days,14 days and 28 days after randomization
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Cost-utility analysis (CUA) ratio
The cost-utility ratio (C/U) is measured at baseline,7days,14 days and 28 days after randomization
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Incremental cost-effectiveness ratio and Incremental cost-utility ratio
Incremental cost-effectiveness ratio and Incremental cost-utility ratio are measured at baseline,7days,14 days and 28 days after randomization.
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
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