search
Back to results

Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain (CNLBPCT)

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese Tuina therapy
Flurbiprofen Cataplasms group (FCG).
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring Massage, Tuina, Traditional Chinese medicine, CEA, CUA, ICER

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beiing university of Chinese medicine Dongzhimen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chinese Tuina group (CTG)

Flurbiprofen Cataplasms group (FCG)

Arm Description

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.

The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days.

Outcomes

Primary Outcome Measures

Changes in NRS scores for pain intensity
The changes in NRS scores at 14 days after randomization.

Secondary Outcome Measures

Changes in NRS scores for pain intensity
The NRS scores are measured at baseline, 7 days and 28days 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
Clinical effective rate
The clinical response rate is measured at baseline, 7 days, 14 days 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
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
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
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
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
Incidence of adverse events
The incidence of adverse events during treatment will be calculated
Cost-Effectiveness Analysis (CEA) ratio
The cost-effectiveness ratio (C/E) is measured at baseline,7days,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
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.

Full Information

First Posted
July 15, 2021
Last Updated
January 1, 2022
Sponsor
Beijing University of Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT04976790
Brief Title
Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain
Acronym
CNLBPCT
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
Massage, Tuina, Traditional Chinese medicine, CEA, CUA, ICER

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Tuina group (CTG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Flurbiprofen Cataplasms group (FCG)
Arm Type
Active Comparator
Arm Description
The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days.
Intervention Type
Behavioral
Intervention Name(s)
Chinese Tuina therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen Cataplasms group (FCG).
Other Intervention Name(s)
ZePuSi
Intervention Description
One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
Primary Outcome Measure Information:
Title
Changes in NRS scores for pain intensity
Description
The changes in NRS scores at 14 days after randomization.
Time Frame
Change from baseline at 14 days
Secondary Outcome Measure Information:
Title
Changes in NRS scores for pain intensity
Description
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
Title
Changes in the ODI scores for lumbar function
Description
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
Title
Clinical effective rate
Description
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
Title
Changes in 7-level Likert Scale for patient assessment global improvement
Description
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
Title
Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
Description
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
Title
Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
Description
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
Title
Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
Description
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
Title
Changes in Quality adjusted life years (QALY)
Description
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
Title
Incidence of adverse events
Description
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
Title
Cost-Effectiveness Analysis (CEA) ratio
Description
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
Title
Cost-utility analysis (CUA) ratio
Description
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
Title
Incremental cost-effectiveness ratio and Incremental cost-utility ratio
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changhe Yu
Phone
0086-18601159559
Email
yakno2@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiyou Wang
Phone
0086-8610111889
Email
dwxy658@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiyou Wang
Organizational Affiliation
Beijing University of Chinese Medicine affiliated Dongzhimen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beiing university of Chinese medicine Dongzhimen Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiyou Wang
Phone
01084013296
Email
dwxy658@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain

We'll reach out to this number within 24 hrs