ChiCTR2000040288 版本V1.0 版本创建时间2020/11/27 06:50:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000040288 

最近更新日期：

Date of Last Refreshed on：

 2020-11-27 06:50:43 

注册时间：

Date of Registration：

 2020-11-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

推拿治疗慢性腰痛的疗效：一项多中心随机对照试验（RCT）

Public title：

A Multi-center Randomized Controlled Trial (RCT) on the Effectiveness of T uina in Managing Chronic Low Back Pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

推拿治疗慢性腰痛的疗效：一项多中心随机对照试验（RCT）

Scientific title：

A Multi-center Randomized Controlled Trial (RCT) on the Effectiveness of T uina in Managing Chronic Low Back Pain

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

周旋 

研究负责人：

陈家旭 

Applicant：

Xuan Zhou 

Study leader：

Jiaxu Chen 

申请注册联系人电话：

Applicant telephone：

 13128235547

研究负责人电话：

Study leader's
telephone：

13910800582

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 xuetcm@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 chenjiaxu@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

广东省广州市天河区黄埔大道西601号

研究负责人通讯地址：

广东省广州市天河区黄埔大道西601号

Applicant address：

No.601, West Huangpu Avenue, Tianhe District, Guangzhou, China

Study leader's address：

No.601, West Huangpu Avenue, Tianhe District, Guangzhou, China

申请注册联系人邮政编码：

Applicant postcode：

 510632

研究负责人邮政编码：

Study leader's postcode：

 510632

申请人所在单位：

暨南大学中医学院

Applicant's institution：

School of Traditional Chinese Medicine, Jinan University

研究负责人所在单位：

暨南大学中医学院

Affiliation of the Leader：

School of Traditional Chinese Medicine, Jinan University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 KY-2019-042

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

暨南大学附属第一医院医学伦理委员会

Name of the ethic committee：

IRB of the First Affiliated Hospital of Jinan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-11-29 00:00:00

伦理委员会联系人：

罗老师

Contact Name of the ethic committee：

Mr luo

伦理委员会联系地址：

广州市天河区黄埔大道西613号

Contact Address of the ethic committee：

No.613, West Huangpu Avenue, Tianhe District, Guangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

暨南大学中医学院

Primary sponsor：

School of Traditional Chinese Medicine, Jinan University

研究实施负责（组长）单位地址：

广东省广州市天河区黄埔大道西601号

Primary sponsor's address：

No.601, West Huangpu Avenue, Tianhe District, Guangzhou, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

暨南大学中医学院

具体地址：

广东省广州市天河区黄埔大道西601号

Institution
hospital：

School of Traditional Chinese Medicine, Jinan University

Address：

601 West Huangpu Avenue, Tianhe District

经费或物资来源：

新加坡HEAD基金会

Source(s) of funding：

The HEAD Foundation

研究疾病：

慢性腰痛  

Target disease：

Chronic Low Back Pain

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

① 与物理治疗相比，观察推拿治疗慢性非特异性腰痛的疗效。 ② 与物理治疗、推拿治疗相比，探索推拿结合物理治疗治疗慢性非特异性腰痛的疗效。  

Objectives of Study：

(1)To observe the effectiveness of Tuina compared to the control group, which is routine management using Physiotherapy (PT) on patients with CNLBP. (2)In addition, we will also explore the effectiveness of Tuina combined with PT (T&P) as an intervention modality for CNLBP, comparing it with Tuina and PT management.

药物成份或治疗方案详述：

1. 推拿治疗方案 1.1 操作人员 手法操作人员均为取得执业医师资格证书，在临床治疗实践超过三年，并通过本课题临床标准操作培训合格的推拿医师。 1.2 推拿操作规范 ① 理顺腰背。 患者俯卧位，医生站于一侧，以掌推法，从上至下分别推腰背部督脉（大椎穴至长强穴）、两侧足太阳膀胱经（大杼穴至承山穴），每条经推5遍。（时间约5min） ② 揉法舒筋。 患者俯卧位，医生站于一侧，先以掌根揉法，从上至下往返作用于背部及腰骶部两侧肌肉，力度由轻至重；再以拇指按揉法，依次按揉腰骶部的肾俞穴（双侧）、腰阳关穴、气海俞穴（双侧）、大肠俞穴（双侧）、秩边穴（双侧），以穴位局部出现酸胀感为度，并用掌根揉法在痛点周围进行按揉。（时间约10min） ③ 点按止痛。 患者俯卧位。医生站于一侧，以点按法，依次点按小腿部的阳陵泉穴（双侧）、委中穴（双侧）、承山穴（双侧），以穴位局部出现酸胀感为度。（时间约3min） ④ 弹拨解痉。 患者俯卧位，医生站于一侧，以拇指拨法（以拇指指腹按于治疗部位，以上肢带动拇指，垂直于肌腹做往返推动）或掌指拨法（以一手拇指指腹置于治疗部位，另一手手掌置于该拇指之上，以掌发力，以拇指着力，垂直于肌腹做往返推动），从上至下沿脊椎两侧，左右弹拨两侧竖脊肌，以患者能耐受为度。（时间约5min） ⑤ 擦法温通。 患者俯卧位，医生站于一侧，以小鱼际擦法，先“直”擦腰背部两侧足太阳膀胱经，再“横”擦腰骶部，以手法作用部位产生热感为度。（时间约4min） ⑥ 牵拉腰背肌。 患者仰卧位，屈髋屈膝。医生站于一侧，以双手按压患者两侧膝前，使患者极度屈髋屈膝，以患者能耐受为度。（时间约3min） 1.3 治疗疗程 每1-2周1次，在8周内共治疗6次，每次治疗时间30min。 2. PT干预方案 2.1 操作人员 执业物理治疗师是持证的医护人员，已获得相关部门的资格证书并注册，可在其国家执业，这些治疗师要有至少一年的腰痛治疗经验。 2.2 PT操作规范 物理疗法治疗慢性腰痛将遵循以下通用方案： 2.2.1物理治疗评估 (1)对疼痛病史、疼痛性质和过去的治疗干预措施进行详细的主观评估。 (2)对受试者的背景进行心理社会评价。 (3)对肌肉骨骼组织进行详细的客观评估，以确定疼痛的位置、活动范围、功能强度或步态分析、紧绷和任何其他感觉或反射反应的丧失。 2.2.2物理治疗干预 (1)对受试者进行初步功能诊断，这将使物理治疗师能够根据受试者的症状决定具体的治疗方案。 (2)根据受试者的症状和功能障碍，通过临床推理制定治疗方案，可包括以下治疗方案： a.手法治疗：关节松动术或手法可用于减轻关节僵硬或下背部疼痛。 i. 根据需要，对关节进行针对性松动术与软组织松动术。 ii. 根据需要推拿腰椎。 b. 物理因子设备(EPA)：各种物理因子设备可用于减轻疼痛、缓解肌肉紧张和关节僵硬。 i. EPA的类型有热疗(来自各种加热设备，如热包、红外线灯等)、冷疗(如使用冰袋、冰块、冰雾等)、超声波治疗、经皮电刺激治疗、腰椎牵引(如果需要)等。 c. 教育：在工作、家庭和体育活动中提供有关姿势和体位的建议，可能可以帮助维持治疗后的疗效。 i姿势/身体力学-基础和简化 ii保持活动-这样做是安全的 iii限制久坐时间(卧床休息) iv.控制压力，睡好觉，吃好饭，努力减轻疼痛 d.有氧运动： i. 按照美国运动医学院(ASCM)推荐的指导方针逐步进行有氧运动，每次20-30分钟，每次强度达到最大心率的55%-90%，每周至少3天。 ii. 有氧运动例子：散步、游泳、骑自行车等，根据患者的舒适度/喜好而定。 iii. 将运动强度提高到每次训练30至60分钟，每周5-7天。 这些练习不会在所有的PT课程中进行。作为家庭锻炼计划的一部分，将指导受试者自己完成这一目标。PT课程时间有限。这些练习是推荐给受试者的，并不一定要在每次PT课程中进行。 e.柔韧性和核心强化练习(见下文)：本研究将教受试者一系列定制的练习，以拉伸软组织并增强脊柱和周围组织的核心肌肉。 i.下背部伸展和旋转牵拉 ii. 腹式呼吸 iii. 桥式运动 iv. 四点跪位 v. 平板支撑 2.3 治疗疗程 每1-2周1次，每次持续30分钟，8周内治疗6次。 3. 推拿结合PT干预方案 3.1 操作人员 同推拿或物理治疗。 3.2 操作规范 同推拿或物理治疗。 3.3 治疗疗程 每1-2周1次，每次持续30分钟，8周内治疗6次。推拿或物理治疗交替进行（即第奇数次接受推拿治疗，则第偶数次接受物理治疗，或者相反。 

Description for medicine or protocol of treatment in detail：

1 Tuina Intervention 1.1 Tuina Practitioner The Tuina Practitioners are all trained and experienced TCM practitioners. 1.2 Treatment Principle Dredging the meridians and collaterals to provide pain relief by reducing the pain of muscle spasms, promoting qi and blood circulation, as well as soothing the muscles and regulating sinews and joints. 1.3 Regions and Points Regions: Lumbosacral region, hip and lower limbs. Main points: BL23 (shènshù), BL25 (dàchángshù), BL27 (xiǎochángshù), ashi point, BL40 (wěizhōng); GB30 (huántiào) Adjunct acupoints according to syndrome: Damp-heat syndromeGB34（Yáng Líng Quán） Cold-damp syndrome: DU3 (yāoyángguān); Static blood syndrome: BL17 (géshù) Kidney deficiency syndrome: DU4 (mìngmén) and KI3 (tàixī); 1.4 Commonly used manipulations Rolling, kneading, pushing, plucking, pointing, pulling-stretching, pulling, rotation, scrubbing, and patting. 1.5 Standardized Operating Procedures The Tuina techniques that will be used for the treatment of CNLBP are as follows: a. Dredging the meridians and collaterals: Ask the patient to take a prone position. Standing on one side of the patient, apply rolling manipulation from the lumbar region to the lower limbs. Apply palm root-kneading manipulation on spinal erector muscles on both sides of back and lumbosacral region. Continue kneading the lumbosacral and lower limb regions along the Bladder Meridian of Foot Taiyang. (10 minutes) b. Pushing on the back and lumbosacral region: Ask the patient to take a prone position. Standing on one side of the patient, apply palm-pushing manipulation along the Governor Vessel (from DU14 (dàzhuī) to DU2 (yāoshù)) and bilateral courses of Bladder Meridian of Foot Taiyang (from BL11 (dàzhù) to BL30 (báihuánshù)) from the back to the lumbar region, for five times respectively. (2 minutes) c. Plucking manipulation to relieve spasms: Ask the patient to take a prone position. Standing on one side of the patient, apply plucking manipulation with the thumb (Extend the thumb straight, the tip of the thumb is taken as the working point, the other four fingers are placed on the relative areas to assist the thumb, press the thumb on the side of tendons or muscles, then make a transverse plucking movement, perpendicular to the tendons or muscular fibers, like plucking the string of a music instrument) or plucking manipulation with the palm and thumb (Extend the thumb straight, the tip of the thumb is taken as the working point, the palm of the other hand is placed on the thumb (working point) to exert force, press the thumb on the side of tendons or muscles, then make a transverse plucking movement to the vertical tendons or muscular fibers, like plucking the string of a music instrument) on sacrospinalis muscles of back and lumbosacral region bilaterally. Repeat the manipulation up and down for several times, using an amount of strength that the patient can accept. The degree of treatment is based on the patient's tolerance level. (4 minutes) d. Pointing-pressing acupoints to relieve pain: Ask the patient to take a prone position. Standing on one side of the patient, apply pointing-pressing manipulation on BL17 (géshù), BL23 (shènshù), BL25 (dàchángshù), BL27 (xiǎochángshù), ashi point, DU4 (mìngmén), DU3 (yāoyángguān), GB30 (huántiào), BL40 (wěizhōng), KI3 (tàixī), GB34（Yáng Líng Quán） (Selection of acupoints based on syndrome differentiation) located on the back, lumbosacral and leg region till the patient feels soreness and distention. (6 minutes) e. Pulling-stretching manipulation of waist: Ask the patient to take a prone position and hold the top side of the bed with both hands forcefully, the tuina practitioner stands at the foot side of the bed to pull the patient’s body, by holding his ankles with both hands and gradually increasing force. The movements of pulling-stretching manipulation should be stable and gentle. The strength applied increases from mild to strong during pulling to avoid accidents. (1 minutes) f. Pulling manipulation to adjust joints: The patient takes a lateral recumbent position, with the leg on the lower side extended and the upper leg bent at the hip and knee joint placed over the other leg. The Tuina practitioner places an elbow at the patient’s shoulder and the other on the back of the hip on the same side. Twist the patient’s waist by pushing the shoulder and pulling the hip in opposite directions until there is resistance. (2 minutes) g. Rotating the waist to relax the lumbar muscles: The patient takes a supine position with flexed knees and hips. Pressing two knees with one hand to close the knees together and holding the lower parts or ankles of the legs with the other hand, rotate the bent legs clockwise or counterclockwise for 3-5 times respectively to lead the movement of the waist. (1 minutes) h. Scrubbing manipulation to warm the back and lumbosacral region: Ask the patient to take a prone position. Standing on one side of the patient, apply scrubbing manipulation using the palm root of the hand (vertical scrubbing manipulation) along the bilateral courses of Bladder Meridian located on the back and lumbosacral region till a warm sensation is felt at the local area. Then apply scrubbing manipulation using the hypothenar region of the palm (transverse scrubbing manipulation) on the lumbosacral region until a warm sensation is felt at the local area. (3 minutes) i. Patting the waist to end the treatment: Ask the patient to take a prone position. Standing on one side of the patient, apply patting manipulation on the lower back, lumbosacral, buttock and lower limb in regular rhythm. (1 minutes) 1.6 Tuina Treatment Course Treatment will be given once weekly or biweekly as needed, each session lasting about 30-60 minutes, for 6 sessions, over a total of eight weeks. 2 Physiotherapy Intervention 2.1 Practicing Physiotherapists The practicing Physiotherapists are licensed healthcare practitioners and have obtained the qualification certificate or registration from the relevant authorities for practice in their country of practice. These Physiotherapists should have at least 1 year of experience in the management of low back pain. 2.2 Standardized Operating Procedures Physiotherapy treatment for chronic low back pain will follow the following general protocol: 2.2.1 Physiotherapy Assessment (1) A detailed subjective assessment of the history of the pain, the nature of the pain and past treatment interventions is conducted. (2) A psycho-social review of the subject’s background is also conducted. (3) A detailed objective assessment of the musculo-skeletal tissues to determine location of pain, range of motion, functional strength or gait analysis, tightness and any other loss of sensory or reflect responses. 2.2.2 Physiotherapy Intervention (1) A provisional functional diagnosis of the subject is made, which will enable the Physiotherapist to decide on a treatment plan specific to the subject’s symptoms. (2) A treatment plan based on the symptoms and the dysfunction of the subject is developed through clinical reasoning and may include the following treatment options: a. Manual therapy: Joint mobilization or manipulation may be used to reduce joint stiffness or pain from the low back. i. Joint specific mobilization versus soft tissue mobilization as needed. ii. Lumbar manipulation as needed. b. Electrophysical agents (EPA): Various electrophysical agents may be used to reduce pain, muscle tension and joint stiffness. i. The types of EPA are Heat therapy (from various heating devices, e.g. hot packs, infra-red lamps etc.), ice (e.g. using ice packs, ice cubes, ice sprays etc.), ultrasound therapy, transcutaneous electrical sensory stimulation, lumbar traction (if needed) etc. c. Education: Advice on posture and positions for functions at work, home and for sporting activities may be provided to help with ongoing therapy after treatment. i. Posture/body mechanics – basic and simplified ii. Stay active – it is safe to do so iii. Limit sedentary time (bed rest) iv. Manage stress, sleep well, and eat well in an effort to reduce pain d. Aerobic exercise: i. Graded exposure to aerobic exercise will follow the recommended American College of Sports Medicine (ASCM) guidelines of 20 to 30 minutes at any intensity that achieves 55 to 90% of the maximum heart rate, at least 3 days a week. ii. Examples of aerobic exercise: Walking, swimming, bicycling, etc. per patient comfort/preference iii. Advance exercise intensity to 30 to 60 minutes per session, 5-7 days per week. These exercises will not be performed in all PT sessions. Subjects will be instructed to achieve this on their own as part of a home exercise program. PT sessions are limited in time. These exercises are recommended for the subjects and are not necessarily done during each PT session. e. Flexibility and core strengthening exercises (see below): A customized series of exercises to provide stretching of soft tissues and strengthening of the core muscles of the spine and peripheral tissues will be taught to the subject. i. Low back stretch and rotation stretch ii. Abdominal bracing iii. Bridge iv. Quadruped arm/leg lifts v. Plank 2.3 Post Treatment Assessment A detailed re-evaluation of the subject’s pain, spinal ROM, functional assessment is conducted to evaluate the effectiveness of the session intervention and to plan for home exercise program and the next clinic appointment. 2.4 Home Exercise Program and Advice Home exercises to maintain the effects of treatment will also be provided so that subject can continue their treatment at home. Exercise materials may be provided for the subject so that they can review the positions, duration and number of repetitions at home until the next therapy session. 3 Tuina Combined with Physiotherapy Treatment Intervention 3.1 Practicing Clinicians As mentioned above. 3.2 Standardized Operating Procedures Tuina treatment and PT treatment should not be performed on the same session. They may be provided to the subject within the same week or alternate weeks as prescribed by the clinicians. There is no need to stipulate the sequence for the treatment. The same end point is used to discontinue therapy for these patients. 3.3 Treatment Course As mentioned above, the combined Tuina and PT group will have 3 sessions of PT and 3 sessions of Tuina within the 2 months period. 3.4 Permitted and Prohibited Concomitant Treatments Throughout the trial, participants will be discouraged from engaging with other forms of treatments of CNLBP, such as massage, Chiropractic, surgery etc. If subjects have residual pain and require further treatment, they will be recorded for data analysis and discussion. Any other form of treatment that subjects engage in for management of their back pain will also be required to be recorded in the case report form. 

纳入标准：

符合以下条件的人有资格参加研究。 CNLBP的特定诊断标准如下：
A.肋缘和下臀褶之间有病因不明的疼痛和不适，伴有或不伴有下肢疼痛，持续了超过12周。
B.可能是腰部肌肉无力，僵硬，活动受限或脊柱协调性降低。 卧床休息后疼痛症状减轻或消失。弯腰，久坐或长时间站立后，疼痛症状会加重。
C.体格检查显示疼痛区域的肌肉张力增加或明显的局部压痛点（触发点），直腿抬高试验阴性，无神经根病变的迹象。

Inclusion criteria

Those who meet the following criteria are eligible to participate in the study. The specific diagnostic criteria for CNLBP are as follows:
(1)Pain and discomfort of unknown etiology between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs), lasting for more than 12 weeks.
(2)There may be waist muscle weakness, stiffness, limited mobility or reduced spinal coordination. The symptoms of pain are lessened or disappeared after bed rest. While the symptoms of pain are aggravated after bending over, sedentary, or standing for a long time.
(3)Physical examination showed an increase in muscle tension or a significant localized tenderness point (trigger point) in the painful area, with negative straight-leg raising test, and no signs of nerve root lesions.

排除标准：

A. 伴有神经根受损的腰痛患者。
B. 患有严重皮肤疾病（例如皮肤癌，丹毒，严重湿疹，严重皮炎，严重牛皮癣和严重荨麻疹的患者）。
C. 严重的脊柱病变，例如骨折，肿瘤，炎症和感染性疾病。
D. 脊柱手术史。
E. 严重的心血管或代谢异常，如心衰或严重骨质疏松。
F. 精神疾病患者，如抑郁症、精神分裂症、双相情感障碍等。
G. 孕妇，或具有生育能力并在治疗阶段可能怀孕但不愿意使用可靠避孕方式的人也将被排除在外。可靠的避孕方式包括口服避孕药，隔膜或避孕套（含杀精子剂），注射剂，宫内节育器，手术消毒和禁欲。

Exclusion criteria：

Those who meet any of the below exclusion Criteria shall be excluded from the study.
(1) Patients with low back pain associated with nerve root compromise.
(2) Patients with severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus).
(3) Serious spinal pathologies such as fractures, tumors, inflammatory and infectious diseases.
(4) History of spine surgery.
(5) Serious cardiovascular or metabolic disorders, such as heart failure, severe osteoporosis
(6) Patients diagnosed with cognitive issues such as major depression, and moderate to severe dementia severe psychiatric diseases (such as schizophrenia, bipolar affective disorder, paranoid psychosis).
(7) Women who are pregnant, or who are of childbearing potential and are likely to become pregnant during the treatment phase but are not willing to use a reliable form of contraception, will also be excluded. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence.

研究实施时间：

Study execute time：

从 From 2020-12-01 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-12-01 00:00:00 至 To 2022-03-31 00:00:00

干预措施：

Interventions：

组别：

对照组（PT）

样本量：

 204

Group：

control group (PT)

Sample size：

干预措施：

物理治疗

干预措施代码：

Intervention：

Physiotherapy

Intervention code：

组别：

测试组1

样本量：

 204

Group：

Experimental group 1

Sample size：

干预措施：

推拿

干预措施代码：

Intervention：

Tuina

Intervention code：

组别：

测试组2

样本量：

 204

Group：

Experimental group 2

Sample size：

干预措施：

推拿联合物理治疗

干预措施代码：

Intervention：

Tuina and Physiotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 暨南大学附属第一医院 

单位级别：

 三甲医院 

Institution
hospital：

The First Affiliated Hospital of Jinan University

Level of the institution：

Tertiary A Hospital

国家：

 新加坡

省(直辖市)：

 新加坡 

市(区县)：

  

Country：

Singapore

Province：

Singapore

City：

单位(医院)：

 新加坡中央医院 

单位级别：

 三甲医院 

Institution
hospital：

singapore general hospital

Level of the institution：

Tertiary A Hospital

国家：

 美国

省(直辖市)：

 明尼苏达 

市(区县)：

  

Country：

United States

Province：

Minnesota

City：

单位(医院)：

 梅奥诊所 

单位级别：

 三甲医院 

Institution
hospital：

Mayo Clinic

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

疼痛

指标类型：

主要指标

Outcome：

Pain

Type：

Primary indicator

测量时间点：

-1, 9-，20-周

测量方法：

VAS评分

Measure time point of outcome：

-1, 9-and 20-week

Measure method：

VAS scale

指标中文名：

ODI评分

指标类型：

次要指标

Outcome：

ODI score

Type：

Secondary indicator

测量时间点：

-1, 9-，20-周

测量方法：

Measure time point of outcome：

-1, 9-and 20-week

Measure method：

指标中文名：

脊柱ROM评分

指标类型：

次要指标

Outcome：

spinal ROM

Type：

Secondary indicator

测量时间点：

-1, 9-，20-周

测量方法：

Measure time point of outcome：

-1, 9-and 20-week

Measure method：

指标中文名：

SF-36评分

指标类型：

次要指标

Outcome：

SF-36 score

Type：

Secondary indicator

测量时间点：

-1, 9-，20-周

测量方法：

Measure time point of outcome：

-1, 9-and 20-week

Measure method：

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse events

Type：

Secondary indicator

测量时间点：

e) 追踪整个20周

测量方法：

Measure time point of outcome：

throughout the 20 weeks follow up.

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 21 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用分层区组随机方法。采用百奥知公司提供的随机平台进行随机分组，仅主要研究者可以知晓随机号。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study uses a stratified block random method. Random grouping is carried out using the random platform provided by BioZi. Only the main researcher can know the random number.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

由于推拿治疗的特殊性，研究对推拿师、物理治疗师与患者并不设盲，但对于进行疗效评价及随访观察、统计分析的人员，需要设盲。

Blinding：

Due to the particularity of Chinese medicine, Tuina and the PT intervention, the operators or intervention providers and the patients are not blinded. The research accessors perform the efficacy evaluations and follow-up observation, and statistical analysts, hence they will be blinded in this study.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

ResMan （www.medresman.org）

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

ResMan （www.medresman.org）

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1. 数据收集 （1）研究结果的测量：所有基线评估，2个月和5个月的随访数据将由对治疗方式或治疗组不了解的研究协调员收集。 （2）治疗过程评估：治疗前和治疗后评估数据，特别是VAS，将在每次治疗后由临床医生进行测量，并用于验证干预措施在2个月内的结束。也可以使用其他变量，并且可以包括脊柱ROM，ODI和中医证候评分。治疗前和治疗后的数据不用于统计分析，而是用于在2个月的干预阶段内监视受试者干预的结束。? （3）基线后2个月和5个月的随访评估包括VAS，脊柱ROM，ODI，SF-36和中医证候评分。 2. 病例报告表 应使用CRF及时准确地填写参与研究的所有临床研究病例。每个受试者CRF都应保存在上锁的柜子中，只有PI和研究协调员能有限地访问，并且不得随意更改或更改。在研究期结束后，对每个临床受试者进行身份再识别，并将其正确存档。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1Data Collection (1)Study outcome measurement: all baseline assessment, 2-month and 5-month follow up data will be collected by the research coordinator who is blind to the treatment modality or treatment groups. (2)Treatment session evaluation: pre and post treatment evaluation data especially VAS will be measured by the clinicians after each treatment session and used to verify the end of the intervention within the 2 months period. Other variables may also be used and may include spinal ROM, ODI, and TCM Syndrome Score. Pre and post treatment session data are not used for statistical analysis, instead, it is used to monitor the subject for end of intervention within the 2 months intervention phase. (3)Follow up assessment at 2 and 5 months after baseline include VAS, spinal ROM, ODI, SF36 and TCM Syndrome Score. All adverse events and additional treatment engaged by the subject during the follow up period will also be recorded for analysis. 2Case Report Form Record All the clinical research cases enrolled in the study should be filled out in a timely and accurate manner, using a standardized CRF. Each subject CRF should be kept in a locked cabinet with limited access to PI and research coordinators only, and should not be arbitrarily changed or altered. The test form and the test report are neatly pasted in the CRF where appropriate. Each clinical subject will be de-identified and should be properly archived after the end of the study period. All translated documents must be certified by the translators and verified for accuracy of translation.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-27 06:50:43