Chronic Nonspecific Low Back PainCNLBPCTNCT04976790
Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain
A study testing Chinese Tuina therapy and Flurbiprofen Cataplasms group (FCG). in people with Chronic Nonspecific Low Back Pain, run by Beijing University of Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Chinese Tuina therapy and Flurbiprofen Cataplasms group (FCG).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Allergy or intolerance to Non-steroidal anti-inflammatory drug (e.g., asthma, gastrointestinal ulcers, and bleeding);
- Mental illness；
- Poor compliance of examination and treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beiing university of Chinese medicine Dongzhimen Hospital
Beijing, Beijing Municipality
Xiyou Wang, 01084013296, dwxy658@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Chinese Tuina therapy, Flurbiprofen Cataplasms group (FCG).
- Keywords
- Massage, Tuina, Traditional Chinese medicine, CEA, CUA, ICER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Tuina therapyBehavioural
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.
Flurbiprofen Cataplasms group (FCG).Drug
Also called ZePuSi
One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Chinese Tuina group (CTG) | Experimental | 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. Receives: Behavioral: Chinese Tuina therapy |
| Flurbiprofen Cataplasms group (FCG) | Active comparator | The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days. Receives: Drug: Flurbiprofen Cataplasms group (FCG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in NRS scores for pain intensity
The changes in NRS scores at 14 days after randomization.
Measured: Change from baseline at 14 days
Secondary outcomes (12)
Changes in NRS scores for pain intensity
The NRS scores are measured at baseline, 7 days and 28days after randomization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline at 7 days,14 days and 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start28 Oct 2021
- Primary completion15 Feb 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changhe Yu, Beijing University of Chinese Medicine
- Investigators
- Xiyou Wang, Principal investigator, Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976790
- Sponsor's protocol ID
- 2021DZMEC-070-01
- Acronym
- CNLBPCT
- Status last verified
- Jan 2022
- First submitted
- 15 Jul 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Economic Evaluation of Chinese Tuina (Chinese Massage and Flurbiprofen Cataplasms) in the Treatment of Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT04976790
- Acronym / sponsor ID
- CNLBPCT / 2021DZMEC-070-01
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Massage, Tuina, Traditional Chinese medicine, CEA, CUA, ICER
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chinese Tuina group (CTG) | Experimental | Behavioral: Chinese Tuina therapyThe 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. |
| Flurbiprofen Cataplasms group (FCG) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Tuina therapyFirstly, 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. | Behavioural | Chinese Tuina group (CTG) |
| Flurbiprofen Cataplasms group (FCG).Also: ZePuSiOne Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days | Drug | Flurbiprofen Cataplasms group (FCG) |
Primary outcome
Changes in NRS scores for pain intensity
Time frame: Change from baseline at 14 days
The changes in NRS scores at 14 days after randomization.
12 secondary outcomes
Changes in NRS scores for pain intensity
Time frame: Change from baseline at 7 days and 28 days after randomization
Changes in the ODI scores for lumbar function
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Clinical effective rate
Time frame: Change from baseline at 7days,14days and 28 days after randomization
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
Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
Time frame: Change from baseline at 14 days after randomization
Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
Time frame: Change from baseline at 14 days after randomization
Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
Time frame: Change from baseline at 14 days after randomization
Changes in Quality adjusted life years (QALY)
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Incidence of adverse events
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Cost-Effectiveness Analysis (CEA) ratio
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Cost-utility analysis (CUA) ratio
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Incremental cost-effectiveness ratio and Incremental cost-utility ratio
Time frame: Change from baseline at 7 days,14 days and 28 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiyou Wang principal investigator
Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Tuina therapy and Flurbiprofen Cataplasms group (FCG). in people with Chronic Nonspecific Low Back Pain, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changhe Yu (0086-18601159559, yakno2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in NRS scores for pain intensity (time frame: Change from baseline at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.