Clinical trial NCT04976790: Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain
Official title: Effectiveness, Safety and Economic Evaluation of Chinese Tuina (Chinese Massage and Flurbiprofen Cataplasms) in the Treatment of Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: Massage
Tuina
Traditional Chinese medicine
CEA
CUA
ICER
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in NRS scores for pain intensity
timeFrame: Change from baseline at 14 days
Secondary outcomes:
measure: Changes in NRS scores for pain intensity
timeFrame: Change from baseline at 7 days and 28 days after randomization
measure: Changes in the ODI scores for lumbar function
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Clinical effective rate
timeFrame: Change from baseline at 7days,14days and 28 days after randomization
measure: Changes in 7-level Likert Scale for patient assessment global improvement
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
timeFrame: Change from baseline at 14 days after randomization
measure: Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
timeFrame: Change from baseline at 14 days after randomization
measure: Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
timeFrame: Change from baseline at 14 days after randomization
measure: Changes in Quality adjusted life years (QALY)
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Incidence of adverse events
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Cost-Effectiveness Analysis (CEA) ratio
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Cost-utility analysis (CUA) ratio
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
measure: Incremental cost-effectiveness ratio and Incremental cost-utility ratio
timeFrame: Change from baseline at 7 days,14 days and 28 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beiing university of Chinese medicine Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
name: Xiyou Wang
role: PRINCIPAL_INVESTIGATOR
References: