- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04976790
Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain (CNLBPCT)
January 1, 2022 updated by: Changhe Yu, Beijing University of Chinese Medicine
Effectiveness, Safety and Economic Evaluation of Chinese Tuina (Chinese Massage and Flurbiprofen Cataplasms) in the Treatment of Chronic Nonspecific Low Back Pain
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Changhe Yu
- Phone Number: 0086-18601159559
- Email: yakno2@163.com
Study Contact Backup
- Name: Xiyou Wang
- Phone Number: 0086-8610111889
- Email: dwxy658@163.com
Study Locations
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Beijing
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Beijing, Beijing, China
- Recruiting
- Beiing university of Chinese medicine Dongzhimen Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chinese Tuina group (CTG)
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.
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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.
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Active Comparator: Flurbiprofen Cataplasms group (FCG)
The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days.
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One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in NRS scores for pain intensity
Time Frame: Change from baseline at 14 days
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The changes in NRS scores at 14 days after randomization.
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Change from baseline at 14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in NRS scores for pain intensity
Time Frame: Change from baseline at 7 days and 28 days after randomization
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The NRS scores are measured at baseline, 7 days and 28days after randomization
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Change from baseline at 7 days and 28 days after randomization
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Changes in the ODI scores for lumbar function
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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The ODI (Oswestry Low Back Pain Disability Index) scores are measured at baseline, 7 days, 14 days and 28 days after randomization
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Change from baseline at 7 days,14 days and 28 days after randomization
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Clinical effective rate
Time Frame: Change from baseline at 7days,14days and 28 days after randomization
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The clinical response rate is measured at baseline, 7 days, 14 days and 28 days after randomization
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Change from baseline at 7days,14days and 28 days after randomization
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Changes in 7-level Likert Scale for patient assessment global improvement
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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The PAG with 7-level Likert Scale is measured at baseline, 7 days, 14 days and 28 days after randomization
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Change from baseline at 7 days,14 days and 28 days after randomization
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Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
Time Frame: Change from baseline at 14 days after randomization
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The PAG with PROMIS® Scale v1.2 Scale is measured at baseline, 14 days after randomization
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Change from baseline at 14 days after randomization
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Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
Time Frame: Change from baseline at 14 days after randomization
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The Quebec Low Back Pain Disability Scale scores are measured at baseline and 14 days after randomization
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Change from baseline at 14 days after randomization
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Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
Time Frame: Change from baseline at 14 days after randomization
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The PROMIS® Item Bank v2.0-Physical
Function-Short Form 8c 7-Day Scale scores are measured at baseline and 14 days after randomization
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Change from baseline at 14 days after randomization
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Changes in Quality adjusted life years (QALY)
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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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
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Change from baseline at 7 days,14 days and 28 days after randomization
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Incidence of adverse events
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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The incidence of adverse events during treatment will be calculated
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Change from baseline at 7 days,14 days and 28 days after randomization
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Cost-Effectiveness Analysis (CEA) ratio
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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The cost-effectiveness ratio (C/E) is measured at baseline,7days,14 days and 28 days after randomization
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Change from baseline at 7 days,14 days and 28 days after randomization
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Cost-utility analysis (CUA) ratio
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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The cost-utility ratio (C/U) is measured at baseline,7days,14 days and 28 days after randomization
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Change from baseline at 7 days,14 days and 28 days after randomization
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Incremental cost-effectiveness ratio and Incremental cost-utility ratio
Time Frame: Change from baseline at 7 days,14 days and 28 days after randomization
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Incremental cost-effectiveness ratio and Incremental cost-utility ratio are measured at baseline,7days,14 days and 28 days after randomization.
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Change from baseline at 7 days,14 days and 28 days after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2021
Primary Completion (Anticipated)
February 15, 2022
Study Completion (Anticipated)
May 15, 2022
Study Registration Dates
First Submitted
July 15, 2021
First Submitted That Met QC Criteria
July 15, 2021
First Posted (Actual)
July 26, 2021
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 1, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Flurbiprofen
Other Study ID Numbers
- 2021DZMEC-070-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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