A Randomized Controlled Trial (RCT) on the Effectiveness of Tuina in Managing Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Change from baseline spinal Range of Motion at 2 months
研究概览
简要总结
Low back pain (LBP) is a common clinical symptom prompting patients to seek medical care. 80% of adults experience LBP during their lifetime. The causes of CNLBP are still not fully elucidated and there is currently no gold standard treatment for CNLBP. The mainstay of conservative treatment for CNLBP includes pharmacological interventions, weight loss and physiotherapy.
More recently, Tuina, a component of Traditional Chinese Medicine, has been used to treat CNLBP as well. Tuina is mainly applied to the meridians or acupoints by manipulation techniques such as pushing, grasping, pressing and rubbing of the soft tissues or muscles of the body. It is reported to improve circulation and the qi in the body. However, recent systematic reviews on the efficacy of Tuina in the management of CNLBP were not able to definitively conclude the effectiveness of Tuina due to the poor methodological quality of the studies.
Therefore, this study is a single blind, randomized controlled trial (RCT), which aims to determine the efficacy and safety of Tuina in the management of CNLBP. Similar studies are also conducted in China (First Affiliated Hospital of Jinan University) and USA (Mayo Clinic).
Patients from SGH Orthopaedic clinics with CNLBP, will be recruited for this RCT, and will be randomly divided into 3 intervention groups: Physiotherapy intervention group as the control group, Tuina intervention group, and combined intervention (Tuina + Physiotherapy) group. The intervention will last for 2 months, and follow up assessments will be conducted at the 5th month. Outcome measures include Visual Analog Scale (VAS), Spinal range of motion, Oswestry Disability Index (ODI), TCM Syndrome scale and quality of life 36 item short form survey, (SF-36).
详细描述
This is a randomised controlled study, single blind with the assessor blinded to the intervention groups of the study.
204 patients (68 per group) with CNLBP will be recruited from the Outpatient Spine Clinic of the Department of Orthopaedic Surgery, SGH, as referred by the Orthopaedic Surgeons.
They will be screened by the assessor, using the inclusion and exclusion criteria listed in K1 and K2 and if consent is given, baseline assessment of the outcomes variables will be conducted. After assessment, the subjects will be randomized into Tuina (TN) group and control physiotherapy (PT) group and Tuina combined physiotherapy (TP) group in a 1:1:1 ratio by the PI. Stratified blocked randomization method will be used in this study. The assessor remainds blind to the treatment groups for all outcome assessments. Standard Physiotherapy and Tuina procedures will be used in the treatment of the subjects according to their presenting symptoms. Education and home exercises will also be taught as appropriate. All subjects will be provided with a maximum of 6 treatment sessions, after which a post-intervention assessment will be conducted.
The intervention that is not standard is the combination of Tuina and Physiotherapy sessions, which is the intervention in Group TP.
Due to the particularity of Tuina and the PT intervention, the operators or intervention providers and the patients are not blinded to the treatment group. The Research Accessors perform the baseline evaluations and follow-up observation, and statistical analysis, hence they will be blinded in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the Principal Investigator would not be blinded. The randomizing scheme will be produced by using statistical analysis software SAS 9.3 with "proc plan" program or excel randomization program to generate the randomization codes. After production, it will be signed and sealed by the Principal Investigator. It will not be allowed to be checked by anyone except the Principal Investigator. Blinded research assessors in each center will be responsible for getting random envelopes from the PI.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participants aged 21 to 75 years old, regardless of gender, who has CNLBP according to the specific diagnostic criteria below:
- •Pain and discomfort of unknown etiology in the low back region, (with or without referred pain to the lower limbs), lasting for more than 12 weeks.
- •There may be muscle weakness, stiffness, limited mobility or reduced spinal coordination during spinal movement.
- •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 lesion
排除标准
- •Patients with severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus).
- •Recent (within the last month) episodes of spinal pathologies such as fractures, tumors, inflammatory and infectious diseases.
- •History of spine surgery.
- •Recent (within the last month) episodes of cardiovascular or metabolic disorders.
- •Patients diagnosed with psychosocial factors affecting the cognitive and mental faculties such as major depression, moderate to severe dementia and severe psychiatric diseases (such as schizophrenia, bipolar affective disorder, and paranoid psychosis).
- •Women who are Pregnant.
- •Full-time National Service men or on workmen compensation.
结局指标
主要结局
Change from baseline spinal Range of Motion at 2 months
时间窗: From date of randomization until date of first documented progression, up to 60 days
Degree of Spinal flexion and side/lateral flexion range of motion using goniometer and inclinometer
Change from baseline Oswestry Disability Index at 2 months
时间窗: From date of randomization until date of first documented progression, up to 60 days
A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Higher scores mean worse outcome.
Change from baseline Visual Analog Scale at 2 months
时间窗: From date of randomization until date of first documented progression, up to 60 days
Recording pain according to number on the scale. Min value is 0 and max value is 10. Higher scores mean worse outcome.
Change from post recruitment 2 months Oswestry Disability Index at 5 months
时间窗: From date of randomization until date of second documented progression, up to 150 days
A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Higher scores mean worse outcome.
Change from post recruitment 2 months Visual Analog Scale at 5 months
时间窗: From date of randomization until date of second documented progression, up to 150 days
Recording pain according to number on the scale. Min value is 0 and max value is 10. Higher scores mean worse outcome.
Change from post recruitment 2 months spinal Range of Motion at 5 months
时间窗: From date of randomization until date of second documented progression, up to 150 days
Degree of Spinal flexion and side/lateral flexion range of motion using goniometer and inclinometer
Change from post recruitment 2 months 36- item Short Form Survey at 5 months
时间窗: From date of randomization until date of second documented progression, up to 150 days
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Change from baseline Traditional Chinese Medicine Syndrome scale at 2 months
时间窗: From date of randomization until date of first documented progression, up to 60 days
The presence of a TCM syndrome is diagnosed when the individual syndrome's score is \>7. The severity level of the syndrome is further divided into mild (score, 7-14), moderate (score, 15-22), and severe (score ≥23), with 30 being the highest score.
Change from baseline 36- item Short Form Survey at 2 months
时间窗: From date of randomization until date of first documented progression, up to 60 days
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Change from post recruitment 2 months Traditional Chinese Medicine Syndrome scale at 5 months
时间窗: From date of randomization until date of second documented progression, up to 150 days
The presence of a TCM syndrome is diagnosed when the individual syndrome's score is \>7. The severity level of the syndrome is further divided into mild (score, 7-14), moderate (score, 15-22), and severe (score ≥23), with 30 being the highest score.
Physiotherapy / Tuina treatment satisfaction survey at 2mths
时间窗: From date of randomization until date of first documented progression, up to 60 days
Recording satisfaction according to number on the scale. Min value is 0 and max value is 4.
次要结局
未报告次要终点