Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain

NCT04976790 | Unknown

• 1 other identifier: 2021DZMEC-070-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Massage; Tuina; Traditional Chinese medicine; CEA; CUA; ICER

Outcome Measures

Primary Outcomes (1)

• Changes in NRS scores for pain intensity

  The changes in NRS scores at 14 days after randomization.

  Change from baseline at 14 days

Secondary Outcomes (12)

• Changes in NRS scores for pain intensity

  Change from baseline at 7 days and 28 days after randomization

• Changes in the ODI scores for lumbar function

  Change from baseline at 7 days,14 days and 28 days after randomization

• Clinical effective rate

  Change from baseline at 7days,14days and 28 days after randomization

• Changes in 7-level Likert Scale for patient assessment global improvement

  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

  Change from baseline at 14 days after randomization

Study Arms (2)

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.

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.

Drug: Flurbiprofen Cataplasms group (FCG).

Interventions

Chinese Tuina therapy BEHAVIORAL

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.

Chinese Tuina group (CTG)

Flurbiprofen Cataplasms group (FCG). DRUG

One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days

Also known as: ZePuSi

Flurbiprofen Cataplasms group (FCG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Beiing university of Chinese medicine Dongzhimen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Xiyou Wang

  Beijing University of Chinese Medicine affiliated Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changhe Yu

CONTACT

0086-18601159559; yakno2@163.com

Xiyou Wang

CONTACT

0086-8610111889; dwxy658@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: October 28, 2021
• Primary Completion: February 15, 2022
• Study Completion: May 15, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)