Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness, Safety and Economic Evaluation of Chinese Tuina (Chinese Massage and Flurbiprofen Cataplasms) in the Treatment of Chronic Nonspecific Low Back Pain

Conditions
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Chronic Nonspecific Low Back Pain

Intervention / Treatment
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* Behavioral: Chinese Tuina therapy
* Drug: Flurbiprofen Cataplasms group (FCG).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-specific low back pain; Aged between 18 and 65,male and female; Duration of low back pain as the main symptom for at least 12 weeks; pain intensity with NRS score equals or more than 4; X-ray or CT on low back helped to confirm no lumbar diseases; Ability to understand and complete the questionnaires; Any treatments aiming to CNLBP need more than 1 month washout period; Volunteer to participate in the study and informed consent form. Exclusion Criteria: Sciatica, myelopathy, displacement, or radiculopathy due to lumbar intervertebral disc disorders or Spondylolisthesis； Chronic low back pain caused by local disease (e.g., lumbar fracture, lumbar tumor, lumbar tuberculosis, lumbar spine surgery or trauma)； Immune diseases such as rheumatoid joints and ankylosing spondylitis； Severe primary disease such as cardiovascular, lung, kidney, and hematopoietic disease; Pregnant or lactating women; patients with skin injury; Allergy or intolerance to Non-steroidal anti-inflammatory drug (e.g., asthma, gastrointestinal ulcers, and bleeding); Mental illness； Poor compliance of examination and treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms recruit and evaluate the participants at the same time, and the included participants have the equal opportunity to either the Chinese Tuina or the Flurbiprofen Cataplasms treatment groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Tuina group (CTG)<br>The participants in Chinese Tuina group will receive the traditional Chinese Tuina therapy on the basis of health education and home-exercise. All the treatment will cost 20-25 minutes. Patients in this group received 4 treatments over 14 days. | Behavioral: Chinese Tuina therapy<br>* 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.<br>|
| Active Comparator: Flurbiprofen Cataplasms group (FCG)<br>The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days. | Drug: Flurbiprofen Cataplasms group (FCG).<br>* One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days<br>* Other names: ZePuSi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in NRS scores for pain intensity | The changes in NRS scores at 14 days after randomization. | Change from baseline at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in NRS scores for pain intensity | The NRS scores are measured at baseline, 7 days and 28days after randomization | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Change from baseline at 7 days,14 days and 28 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Tuina, Traditional Chinese medicine, CEA, CUA, ICER